Safety, Tolerability, and Immunogenicity Study of Homolog... | NCT02315703 | Trialant
NCT02315703
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Feb 4, 2025Actual
Enrollment
393Actual
Phase
Phase 1Phase 2
Conditions
Healthy
Interventions
Ad26.Mos.HIV
MVA-Mosaic
gp140 DP Low-dose
gp140 DP High-dose
Placebo
Countries
United States
Rwanda
South Africa
Thailand
Uganda
Protocol Section
Identification Module
NCT ID
NCT02315703
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR106152
Secondary IDs
ID
Type
Description
Link
HIV-V-A004
Other Identifier
Janssen Vaccines & Prevention B.V.
IPCAVD009
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
Official Title
A Phase 1/2a Trial to Evaluate the Safety/Tolerability and Immunogenicity of Homologous Ad26 Mosaic Vector Regimens or Ad26 Mosaic and MVA Mosaic Heterologous Vector Regimens, With High-Dose, Low-Dose or no Clade C gp140 Protein Plus Adjuvant for HIV Prevention
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 22, 2014Actual
Primary Completion Date
Aug 29, 2017Actual
Completion Date
Mar 28, 2022Actual
First Submitted Date
Dec 9, 2014
First Submission Date that Met QC Criteria
Dec 9, 2014
First Posted Date
Dec 12, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2020
Results First Submitted that Met QC Criteria
Oct 13, 2020
Results First Posted Date
Nov 4, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 1, 2017
Certification/Extension First Submitted that Passed QC Review
Feb 1, 2017
Certification/Extension First Posted Date
Feb 2, 2017Estimated
Last Update Submitted Date
Jan 31, 2025
Last Update Posted Date
Feb 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Vaccines & Prevention B.V.INDUSTRY
Collaborators
Name
Class
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
US Military HIV Research Program
NETWORK
Beth Israel Deaconess Medical Center
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.
Detailed Description
This is a multicenter (more than 1 hospital or medical school team work on a study), randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. All eligible participants will be randomly assigned to receive 1 of the 8 vaccine regimens. Participants will receive study vaccines (Ad26.Mos.HIV, MVA-Mosaic, gp140 DP, and placebo) 4 times as per assigned regimen. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants will be vaccinated at Baseline (Week 0), Week 12, Week 24 and Week 48), and a Follow-up Period (up to 48 weeks). A long-term follow-up period (approximately 2 years after Week 96) will continue for participants randomized to the regimen subsequently selected for future studies, based on analysis of Week 28 data. If Week 28 data are inconclusive, Week 52 data will be considered for regimen selection. If no clear decision can be made, the extended follow-up period could include participants from more than 1 group for assessing durability of immune responses. Participants' safety will be monitored throughout the study.
Conditions Module
Conditions
Healthy
Keywords
Healthy
Acquired Immuno-Deficiency Syndrome
Acquired Immunodeficiency Syndrome Virus
adenovirus serotype 26
Ad26.Mos.HIV
Modified Vaccinia Ankara
Glycoprotein
Adjuvant
Vaccine
Placebo
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
393Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Participants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: gp140 DP High-dose
Group 2
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: gp140 DP Low-dose
Group 3
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + placebo injection at Week 24 and 48.
Biological: Ad26.Mos.HIV
Drug: Placebo
Group 4
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by modified Vaccinia Ankara (MVA)-Mosaic vaccine + gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: MVA-Mosaic
Biological: gp140 DP High-dose
Group 5
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.Mos.HIV
Biological
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
Up to Week 49 (7 days post any dose)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination.
Up to Week 49 (7 days post any dose)
Percentage of Participants With Unsolicited Adverse Events Post Vaccination
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Up to Week 52 (28 days post vaccination)
Number of Participants With Serious Adverse Events (SAEs) Post Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, 4, 5, 6, 7, and 8). Other adverse events (AEs) were reported for the main study period up to Week 96 for all the groups
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG) and laboratory criteria, and vital signs measurement performed at Screening
Participants are negative for human immunodeficiency virus (HIV) infection at Screening
All female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at Screening, and a negative urine pregnancy test pre-dose on Week 0, 12, 24, and 48
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
Participants are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria:
Participant has chronic active hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
In the 12 months prior to enrollment, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
Participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
Participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
Participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months
Participant has a history of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow up)
Participant has an ECG (per examination and interpretation of a cardiologist) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, including any of the following: a) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS >=120 millisecond [ms], PR interval >=220 ms, any 2nd or 3rd degree AV block, or QTc prolongation [>450 ms]); b) significant repolarization (ST segment or T wave) abnormality; c) significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (for example frequent premature atrial contractions, 2 premature ventricular contractions in a row); d) ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction
Participant has a history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products
van Duijn J, Stieh D, Fernandez N, King D, Gilmour J, Tolboom J, Callewaert K, Willems W, Pau MG, De Rosa SC, McElrath MJ, Barouch DH, Hayes P. Mosaic HIV-1 vaccination induces anti-viral CD8+ T cell functionality in the phase 1/2a clinical trial APPROACH. J Virol. 2023 Oct 31;97(10):e0112623. doi: 10.1128/jvi.01126-23. Epub 2023 Oct 9.
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Periods
Title
Milestones
Reasons Not Completed
Main Study (From Week 0 up to Week 96)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 16, 2020
Mar 23, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
International AIDS Vaccine Initiative
NETWORK
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: MVA-Mosaic
Biological: gp140 DP Low-dose
Group 6
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + placebo injection at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: MVA-Mosaic
Drug: Placebo
Group 7
Experimental
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant + placebo injection at Week 24 and 48.
Biological: Ad26.Mos.HIV
Biological: gp140 DP High-dose
Drug: Placebo
Group 8
Placebo Comparator
Participants will receive 1 placebo injection at Week 0 and 12; followed by 2 placebo injections at Week 24 and 48.
Drug: Placebo
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
MVA-Mosaic
Biological
Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
Group 4
Group 5
Group 6
gp140 DP Low-dose
Biological
The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.
Group 2
Group 5
gp140 DP High-dose
Biological
The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Group 1
Group 4
Group 7
Placebo
Drug
Normal saline, 0.5 mL injection administered intramuscularly.
Group 3
Group 6
Group 7
Group 8
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively.
Week 28
Week 28, 52 and 96
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Week 28, 52 and 96
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1.
Week 16, 26, 28, 52, 78, and 96
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Week 28 and 52
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Week 16, 28, 52, 78, and 96
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value >P95 if baseline <P95 or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Week 26, 50, 78 and 96
Miami
Florida
United States
Rockville
Maryland
United States
Boston
Massachusetts
United States
Austin
Texas
United States
Kigali
Rwanda
Cape Town
South Africa
Durban
South Africa
Johannesburg
South Africa
Bangkok
Thailand
Entebbe
Uganda
Kampala
Uganda
Derived
Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6.
FG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
FG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
FG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
FG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
FG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
FG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
FG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
FG00050 subjects
FG00149 subjects
FG00249 subjects
FG00348 subjects
FG00449 subjects
FG00549 subjects
FG00650 subjects
FG00749 subjects
COMPLETED
FG00044 subjects
FG00139 subjects
FG00244 subjects
FG00339 subjects
FG00441 subjects
FG00543 subjects
FG00637 subjects
FG00742 subjects
NOT COMPLETED
FG0006 subjects
FG00110 subjects
FG0025 subjects
FG0039 subjects
FG0048 subjects
FG0056 subjects
FG00613 subjects
FG0077 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Lost to Follow-up
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0033 subjects
FG004
Other
FG0004 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
LTE (After Week 96 up to Week 336)
Type
Comment
Milestone Data
STARTED
FG00031 subjects
FG00132 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00029 subjects
FG00127 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
BG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
BG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
BG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
BG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
BG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
BG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
BG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00149
BG00249
BG00348
BG00449
BG00549
BG00650
BG00749
BG008393
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00029.8± 7.77
BG00129.6± 7.49
BG00231.1± 8.22
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00126
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
RWANDA
Title
Measurements
BG0007
BG0017
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Posted
Number
percentage of participants
Up to Week 49 (7 days post any dose)
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00050
OG00149
OG00249
OG003
Title
Denominators
Categories
Title
Measurements
OG00088.0
OG00183.7
OG00275.5
OG003
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination.
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Posted
Number
percentage of participants
Up to Week 49 (7 days post any dose)
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Primary
Percentage of Participants With Unsolicited Adverse Events Post Vaccination
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Posted
Number
percentage of participants
Up to Week 52 (28 days post vaccination)
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Primary
Number of Participants With Serious Adverse Events (SAEs) Post Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, 4, 5, 6, 7, and 8). Other adverse events (AEs) were reported for the main study period up to Week 96 for all the groups
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Primary
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively.
Per protocol immunogenicity (PPI) analysis set: participants who received at least first 3 vaccines as scheduled, had at least 1 post-vaccination immunogenicity blood draw and not diagnosed with HIV. N(number of participants analyzed): participants who were evaluable for this OM. n(number analyzed): participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of responders
Week 28
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 28, 52 and 96
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 28, 52 and 96
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 16, 26, 28, 52, 78, and 96
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 28 and 52
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 16, 28, 52, 78, and 96
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Secondary
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value >P95 if baseline <P95 or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Posted
Number
95% Confidence Interval
percentage of responders
Week 26, 50, 78 and 96
ID
Title
Description
OG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
Time Frame
Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
Description
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
0
50
8
50
40
50
EG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
0
49
3
49
36
49
EG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
0
49
3
49
42
49
EG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
0
48
4
48
42
48
EG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
0
49
4
49
34
49
EG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
0
49
5
49
41
49
EG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
0
50
2
50
43
50
EG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
0
49
5
49
38
49
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG0031 affected48 at risk
EG0040 affected49 at risk
EG0050 affected49 at risk
EG0060 affected50 at risk
EG0070 affected49 at risk
Mallory-Weiss Syndrome
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Local Swelling
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Corona Virus Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hiv Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tonsillitis Bacterial
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tubo-Ovarian Abscess
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Stab Wound
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Intraductal Proliferative Breast Lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Blighted Ovum
Pregnancy, puerperium and perinatal conditions
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Complication of Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Foetal Death
Pregnancy, puerperium and perinatal conditions
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Neonatal Disorder
Pregnancy, puerperium and perinatal conditions
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Adjustment Disorder
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Generalised Anxiety Disorder
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Miscarriage of Partner
Social circumstances
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pregnancy of Partner
Social circumstances
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG0030 affected48 at risk
EG0040 affected49 at risk
EG0050 affected49 at risk
EG0061 affected50 at risk
EG0070 affected49 at risk
Hypochromic Anaemia
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0012 affected49 at risk
EG0023 affected49 at risk
EG003
Atrioventricular Block First Degree
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Bundle Branch Block Right
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Conduction Disorder
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Deafness Unilateral
Ear and labyrinth disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Thyroid Mass
Endocrine disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Eye Irritation
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Eye Pain
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Eye Swelling
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Eyelid Pain
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hypermetropia
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Ocular Discomfort
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Photophobia
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0004 affected50 at risk
EG0011 affected49 at risk
EG0022 affected49 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0022 affected49 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Lip Blister
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Peptic Ulcer
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Salivary Hypersecretion
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tongue Dry
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tooth Impacted
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Asthenia
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Chest Discomfort
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Chills
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Face Oedema
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Fatigue
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Feeling Cold
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Feeling Hot
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Injection Site Bruising
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0012 affected49 at risk
EG0022 affected49 at risk
EG003
Injection Site Haemorrhage
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Injection Site Hypersensitivity
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Injection Site Pain
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Malaise
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pain
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Pyrexia
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Tenderness
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Food Allergy
Immune system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Abscess
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Acute Hiv Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Amoebiasis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Ascariasis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Bacterial Vaginosis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Body Tinea
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Candida Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Chlamydial Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dermatitis Infected
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0003 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Genital Herpes Simplex
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Gonorrhoea
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hookworm Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0004 affected50 at risk
EG0013 affected49 at risk
EG0025 affected49 at risk
EG003
Localised Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Malaria
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0012 affected49 at risk
EG0023 affected49 at risk
EG003
Oophoritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Parasitic Gastroenteritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Pharyngitis Streptococcal
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pyuria
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0022 affected49 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Skin Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Syphilis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tinea Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Typhoid Fever
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0005 affected50 at risk
EG0016 affected49 at risk
EG0022 affected49 at risk
EG003
Urethritis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Urethritis Chlamydial
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0012 affected49 at risk
EG0025 affected49 at risk
EG003
Urogenital Trichomoniasis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Varicella
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0023 affected49 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Vulvovaginitis Trichomonal
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0012 affected49 at risk
EG0020 affected49 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Muscle Contusion
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Post Procedural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Procedural Dizziness
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Procedural Headache
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Stress Fracture
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0006 affected50 at risk
EG0013 affected49 at risk
EG0022 affected49 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0004 affected50 at risk
EG0011 affected49 at risk
EG0024 affected49 at risk
EG003
Blood Creatine Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Creatinine Decreased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0003 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Pressure Diastolic Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Pressure Systolic
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Pressure Systolic Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Blood Urine Present
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Electrocardiogram QT Prolonged
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0023 affected49 at risk
EG003
Eosinophil Percentage Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0012 affected49 at risk
EG0024 affected49 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0022 affected49 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0012 affected49 at risk
EG0020 affected49 at risk
EG003
Protein Urine
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Red Blood Cells Urine
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
White Blood Cells Urine
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Abnormal Loss of Weight
Metabolism and nutrition disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0013 affected49 at risk
EG0023 affected49 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Burning Sensation
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Dizziness Exertional
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0023 affected49 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0014 affected49 at risk
EG0025 affected49 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Parosmia
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Affective Disorder
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Libido Disorder
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0022 affected49 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0004 affected50 at risk
EG0014 affected49 at risk
EG0022 affected49 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Breast Tenderness
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Genital Discharge
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Genital Rash
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Genital Ulceration
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0022 affected49 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Premenstrual Syndrome
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Vaginal Discharge
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Allergic Sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Dry Throat
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Cold Sweat
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Dermatosis
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected49 at risk
EG003
Rash Generalised
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Pregnancy of Partner
Social circumstances
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected49 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected49 at risk
EG003
Systolic Hypertension
Vascular disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected49 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00050
OG00149
OG00249
OG00348
OG00449
OG00549
OG00650
OG00749
Title
Denominators
Categories
Title
Measurements
OG00088.0
OG00185.7
OG00273.5
OG00375.0
OG00487.8
OG00573.5
OG00662.0
OG00759.2
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00050
OG00149
OG00249
OG00348
OG00449
OG00549
OG00650
OG00749
Title
Denominators
Categories
Title
Measurements
OG00080.0
OG00173.5
OG00285.7
OG00387.5
OG00469.4
OG00583.7
OG00686.0
OG00777.6
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00050
OG00149
OG00249
OG00348
OG00449
OG00549
OG00650
OG00749
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
OG0023
OG0034
OG0044
OG0055
OG0062
OG0075
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00049
OG00141
OG00246
OG00344
OG00444
OG00542
OG00644
OG00746
Title
Denominators
Categories
Clade A (92UG037.1)
ParticipantsOG00048
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00344
ParticipantsOG00443
ParticipantsOG00542
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG000100.0(92.6 to 100)
OG00197.6(87.14 to 99.94)
OG00297.8(88.47 to 99.94)
OG003
Clade B (1990a)
ParticipantsOG00048
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00342
Clade C (Con C)
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00344
Clade C (C97ZA.012)
ParticipantsOG00048
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00344
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00047
OG00141
OG00246
OG00345
OG00442
OG00540
OG00644
OG00745
Title
Denominators
Categories
Clade C (C97ZA.012) IgG1 at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
ParticipantsOG00442
ParticipantsOG00540
ParticipantsOG00644
ParticipantsOG00745
Title
Measurements
OG00078.7(64.34 to 89.3)
OG00180.5(65.13 to 91.18)
OG00250.0(34.9 to 65.1)
OG003
Clade C (C97ZA.012) IgG1 at Week 52
ParticipantsOG00044
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
Clade C (C97ZA.012) IgG1 at Week 96
ParticipantsOG00041
ParticipantsOG00138
ParticipantsOG00223
ParticipantsOG00321
Clade C (C97ZA.012) IgG2 at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
Clade C (C97ZA.012) IgG2 at Week 52
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
Clade C (C97ZA.012) IgG3 at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00344
Clade C (C97ZA.012) IgG3 at Week 52
ParticipantsOG00044
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
Clade C (C97ZA.012) IgG3 at Week 96
ParticipantsOG00041
ParticipantsOG00136
ParticipantsOG00225
ParticipantsOG00322
Clade C (C97ZA.012) IgG4 at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00245
ParticipantsOG00345
Clade C (C97ZA.012) IgG4 at Week 52
ParticipantsOG00044
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00049
OG00141
OG00246
OG00344
OG00444
OG00542
OG00644
OG00746
Title
Denominators
Categories
Consensus C (Con C) at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00344
ParticipantsOG00443
ParticipantsOG00542
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG000100(92.45 to 100)
OG001100.0(91.4 to 100)
OG002100.0(92.29 to 100)
OG003
Consensus C (Con C) at Week 52
ParticipantsOG00044
ParticipantsOG00140
ParticipantsOG00242
ParticipantsOG00341
Mos1 at Week 28
ParticipantsOG00046
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
Mos1 at Week 52
ParticipantsOG00044
ParticipantsOG00140
ParticipantsOG00241
ParticipantsOG00340
Mos1 at Week 96
ParticipantsOG00042
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00338
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00047
OG00141
OG00246
OG00345
OG00442
OG00542
OG00644
OG00746
Title
Denominators
Categories
Clade A (92UG037.1) at Week 16
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG0048
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0078
Title
Measurements
OG00020.0(2.52 to 55.61)
OG00120.0(2.52 to 55.61)
OG00210.0(0.25 to 44.5)
OG003
Clade A (92UG037.1) at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
Clade B (1990a) at Week 16
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Clade B (1990a) at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
Clade C (Con C) at Week 16
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Clade C (Con C) at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
Clade C (C97ZA.012) at Week 16
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Clade C (C97ZA.012) at Week 26
ParticipantsOG00046
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (C97ZA.012) at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
Clade C (C97ZA.012) at Week 52
ParticipantsOG00045
ParticipantsOG00139
ParticipantsOG00242
ParticipantsOG00341
Clade C (C97ZA.012) at Week 78
ParticipantsOG00044
ParticipantsOG00139
ParticipantsOG0020
ParticipantsOG0030
Clade C (C97ZA.012) at Week 96
ParticipantsOG00042
ParticipantsOG00138
ParticipantsOG00225
ParticipantsOG00322
Mos1 at Week 16
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Mos1 at Week 28
ParticipantsOG00047
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00048
OG00141
OG00246
OG00345
OG00444
OG00542
OG00644
OG00746
Title
Denominators
Categories
Clade C (MW965.26) Tier 1 at Week 28
ParticipantsOG00048
ParticipantsOG00141
ParticipantsOG00246
ParticipantsOG00345
ParticipantsOG00444
ParticipantsOG00541
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG00054.2(39.17 to 68.63)
OG00141.5(26.32 to 57.89)
OG00221.7(10.95 to 36.36)
OG003
Clade C (MW965.26) Tier 1 at Week 52
ParticipantsOG00045
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00048
OG00140
OG00246
OG00344
OG00444
OG00544
OG00643
OG00745
Title
Denominators
Categories
HIV ENV Con S gp140 CFI(Clade M)IgG1 Ab Week(W)16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00076.6(61.97 to 87.7)
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG00344
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG00340
HIV ENV gp41 IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG00344
HIV ENV gp41 IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG00340
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG003
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG00344
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG00340
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W28
ParticipantsOG00048
ParticipantsOG00137
ParticipantsOG00246
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W52
ParticipantsOG00045
ParticipantsOG00134
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV gp41 IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
HIV ENV gp41 IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG00340
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG00340
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
43HIV ENV gp41 IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG00338
HIV ENV gp41 IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG00338
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00241
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W16
ParticipantsOG00047
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00245
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W52
ParticipantsOG00043
ParticipantsOG00137
ParticipantsOG00240
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W78
ParticipantsOG00043
ParticipantsOG00138
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W96
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV gp41 IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
HIV ENV gp41 IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG00338
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG00343
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG00338
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W16
ParticipantsOG00048
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W28
ParticipantsOG00048
ParticipantsOG00140
ParticipantsOG00246
ParticipantsOG003
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W52
ParticipantsOG00045
ParticipantsOG00137
ParticipantsOG00242
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG003
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W52
ParticipantsOG00035
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG003
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W52
ParticipantsOG00035
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG003
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W52
ParticipantsOG00035
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG003
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG00335
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG00335
HIV ENV gp41 IgA Ab at W16
ParticipantsOG00040
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
HIV ENV gp41 IgA Ab at W28
ParticipantsOG00039
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG00335
HIV ENV gp41 IgA Ab at W52
ParticipantsOG00035
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG00326
Clade A (51802) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade A (51802) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade A (51802) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade A (51802) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade A (51802) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade AE (254008) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade AE (254008) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade AE (254008) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade AE (254008) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade AE (254008) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade AE (A244) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade AE (A244) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade AE (A244) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade AE (A244) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade AE (A244) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (B.6240) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (B.6240) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (B.6240) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (B.6240) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (B.6240) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (BORI) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (BORI) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (BORI) IgG-t Ab at Week 52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (BORI) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (BORI) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp120 IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp120 IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (TT31P) gp120 IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (TT31P) gp120 IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp120 IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade BC (CNE20) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade BC (CNE20) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade BC (CNE20) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade BC (CNE20) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade BC (CNE20) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade BC(BJOX002) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade BC(BJOX002) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade BC(BJOX002) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade BC(BJOX002) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade BC(BJOX002) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C(1086C_D7) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C(1086C_D7) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C(1086C_D7) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C(1086C_D7) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C(1086C_D7) IgG-t Ab at Week 96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
B Clade M (Con 6) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
B Clade M (Con 6) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
B Clade M (Con 6) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
B Clade M (Con 6) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
B Clade M (Con 6) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (SC42261) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (SC42261) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (SC42261) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (SC42261) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (SC42261) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C (CH505TF) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (CH505TF) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (CH505TF) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (CH505TF) IgG-t Ab at W78
ParticipantsOG00038
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C (CH505TF) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
C Clade A (9004S) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C Clade A (9004S) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
C Clade A (9004S) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
C Clade A (9004S) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
C Clade A (9004S) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
C Clade B (RHPA) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C Clade B (RHPA) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
C Clade B (RHPA) IgG-t Ab at Week 52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
C Clade B (RHPA) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
C Clade B (RHPA) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
C Clade B (WITO) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C Clade B (WITO) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
C Clade B (WITO) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
C Clade B (WITO) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
C Clade B (WITO) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
C Clade C (1086C) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C Clade C (1086C) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
C Clade C (1086C) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
C Clade C (1086C) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
C Clade C (1086C) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
C Clade C (BF1266) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C Clade C (BF1266) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
C Clade C (BF1266) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
C Clade C (BF1266) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
C Clade C (BF1266) IgG-t Ab at Week 96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
CF Clade AE (conAE) IgG-t Ab at 16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CF Clade AE (conAE) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
CF Clade AE (conAE) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
CF Clade AE (conAE) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
CF Clade AE (conAE) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
CFI Clade M(Con S) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CFI Clade M(Con S) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
CFI Clade M(Con S) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
CFI Clade M(Con S) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
CFI Clade M(Con S) IgG-t Ab at Week 96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade A (191084) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade A (191084) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade A (191084) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade A (191084) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade A (191084) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade AE (C2101) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade AE (C2101) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade AE (C2101) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade AE (C2101) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade AE (C2101) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade AE (CM244) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade AE (CM244) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade AE (CM244) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade AE (CM244) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade AE (CM244) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (62357.14) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (62357.14) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (62357.14) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (62357.14) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (62357.14) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (CaseA) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (CaseA) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (CaseA) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (CaseA) IgG-t Ab at W78
ParticipantsOG00038
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (CaseA) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (RHPA4259) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (RHPA4259) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (RHPA4259) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (RHPA4259) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (RHPA4259) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp70 IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp70 IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B (TT31P) gp70 IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B (TT31P) gp70 IgG-t Ab at W78
ParticipantsOG00038
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B (TT31P) gp70 IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade B(700010058) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade B(700010058) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade B(700010058) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade B(700010058) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade B(700010058) IgG-t Ab at W96
ParticipantsOG00037
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
Clade BC (BJOX) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade BC (BJOX) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade BC (BJOX) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade BC (BJOX) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade BC (BJOX) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C (96ZM651) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (96ZM651) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (96ZM651) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (96ZM651) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C (96ZM651) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C (BF1266) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (BF1266) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (BF1266) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (BF1266) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C (BF1266) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C (CAP210) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (CAP210) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (CAP210) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (CAP210) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C (CAP210) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C(Ce1086) IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C(Ce1086) IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C(Ce1086) IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C(Ce1086) IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C(Ce1086) IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
Clade C(TV1.21)IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C(TV1.21)IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C(TV1.21)IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C(TV1.21)IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C(TV1.21)IgG-t Ab at W96
ParticipantsOG00037
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
Clade C (001428)IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (001428)IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (001428)IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (001428)IgG-t Ab at W78
ParticipantsOG00040
ParticipantsOG00132
ParticipantsOG0020
ParticipantsOG0030
Clade C (001428)IgG-t Ab at W96
ParticipantsOG00039
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
Clade C (7060101641)IgG-t Ab at W16
ParticipantsOG00044
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Clade C (7060101641)IgG-t Ab at W28
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00243
ParticipantsOG00340
Clade C (7060101641)IgG-t Ab at W52
ParticipantsOG00037
ParticipantsOG00132
ParticipantsOG00239
ParticipantsOG00334
Clade C (7060101641)IgG-t Ab at W78
ParticipantsOG00039
ParticipantsOG00133
ParticipantsOG0020
ParticipantsOG0030
Clade C (7060101641)IgG-t Ab at W96
ParticipantsOG00038
ParticipantsOG00131
ParticipantsOG0020
ParticipantsOG0030
OG001
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
OG002
Group 3: Ad26/Ad26
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
OG003
Group 4: Ad26/MVA + gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG004
Group 5: Ad26/ MVA + gp140 LD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
OG005
Group 6: Ad26/MVA
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
OG006
Group 7: Ad26/ gp140 HD
Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
OG007
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
Units
Counts
Participants
OG00047
OG00139
OG00245
OG00344
OG00443
OG00538
OG00643
OG00746
Title
Denominators
Categories
ENV peptide pool Mos1 at Week (W) 26
ParticipantsOG00047
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00344
ParticipantsOG00443
ParticipantsOG00538
ParticipantsOG00643
ParticipantsOG00746
Title
Measurements
OG00091.5(79.62 to 97.63)
OG00179.5(63.54 to 90.7)
OG00275.0(59.66 to 86.81)
OG003
ENV peptide pool Mos1 at W 50
ParticipantsOG00041
ParticipantsOG00138
ParticipantsOG00241
ParticipantsOG00339
ENV peptide pool Mos2 at W 26
ParticipantsOG00047
ParticipantsOG00139
ParticipantsOG00244
ParticipantsOG00344
ENV peptide pool Mos2 at W 50
ParticipantsOG00039
ParticipantsOG00135
ParticipantsOG00240
ParticipantsOG00338
ENV peptide pool potential T-cell epitopes(PTE)W26