Evaluating the Safety and Immunogenicity of EnvSeq-1 and... | NCT03220724 | Trialant
NCT03220724
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
May 4, 2026Actual
Enrollment
117Actual
Phase
Phase 1
Conditions
HIV Infections
Interventions
CH505TF
CH505w53
CH505w78
CH505 M5
GLA-SE adjuvant
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03220724
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
HVTN 115
Secondary IDs
ID
Type
Description
Link
12042
Registry Identifier
DAIDS-ES Registry Number
Brief Title
Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults
Official Title
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adult Participants
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Feb 2026
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
Aug 22, 2017Actual
Primary Completion Date
Mar 21, 2023Actual
Completion Date
Mar 21, 2023Actual
First Submitted Date
Jul 12, 2017
First Submission Date that Met QC Criteria
Jul 13, 2017
First Posted Date
Jul 18, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jul 14, 2021
Results First Submitted that Met QC Criteria
Jan 30, 2023
Results First Posted Date
Feb 1, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 13, 2026
Last Update Posted Date
May 4, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
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 evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.
Detailed Description
This study will evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults. The three individual EnvSeq-1 HIV vaccine Envs used in this study are called CH505TF gp120, CH505w53 gp120, and CH505w78 gp120.
This study will take place in two parts: Part A and Part B. Participants in Part A will be randomly assigned to one of four groups. Participants in each group will receive CH505TF (admixed with GLA-SE) or placebo by intramuscular (IM) injection at Months 0, 2, 4, 8, and 12.
Study researchers will evaluate participant data from Part A of the study prior to enrolling participants into Part B of the study. Researchers will also evaluate data from Part A to determine the dosing for Part B.
Participants in Part B will be randomly assigned to one of four groups. Participants in each group will receive IM injections at Months 0, 2, 4, 8. GLA-SE will be admixed with all the CH505 gp120 vaccines. Part B, Group 5 will follow a sequential approach to EnvSeq-1 vaccine administration with administration of the CH505TF vaccine at Month 0, then CH505w53 at Month 2, and CH505w78 at Months 4, and 8. Part B, Group 6 participants will follow an additive approach to EnvSeq-1 administration with administration of the CH505TF vaccine at Month 0; then the CH505TF and CH505w53 vaccines at Month 2; then the CH505TF, CH505w53 and CH505w78 vaccines at Month 4; then the CH505w53 and CH505w78 vaccines at Month 8. Part B, Group 7 participants will receive CH505 M5 at Months 0, 2, 4, and 8. Part B, Group 8 participants will receive placebo injections at each time point.
Additional study visits will occur through Month 18 for participants in Part A and through Month 14 for participants in Part B. Visits may include physical examinations and clinical assessments; blood, urine, and stool collection; HIV testing; risk reduction counseling; and interviews/questionnaires. Study staff will contact participants for follow-up health monitoring at Month 24 for participants in Part A and at Month 20 for participants in Part B.
Part C will be an open-label study arm using the EnvSeq-1 proteins in sequential administration (CH505TF, CH505w53, and CH505w78 gp120s) at the same dose as in Part B (400 mcg) to allow for in-depth analysis of B cell precursor frequency.
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
117Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Group 1
Experimental
Participants will receive 20 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Biological: GLA-SE adjuvant
Part A: Group 2
Experimental
Participants will receive 100 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Biological: GLA-SE adjuvant
Part A: Group 3
Experimental
Participants will receive 400 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Biological: GLA-SE adjuvant
Part A: Group 4
Placebo Comparator
Participants will receive placebo at Months 0, 2, 4, 8, and 12.
Biological: Placebo
Part B: Group 5
Experimental
Participants will receive CH505TF at Month 0; CH505w53 at Month 2; and CH505w78 at Months 4, and 8. GLA-SE adjuvant is admixed with all the CH505 gp120 proteins.
Biological: CH505TF
Biological: CH505w53
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CH505TF
Biological
Administered by intramuscular (IM) injection in the thigh
Part A: Group 1
Part A: Group 2
Part A: Group 3
Part B: Group 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Measured through Month 24
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Measured through the Month 12 boost
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Secondary Outcomes
Measure
Description
Time Frame
Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General and Demographic Criteria:
Age of 18 through 50 years
Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits
Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC):
Hemoglobin greater than or equal to 11.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
White blood cell count equal to 3,300 to 12,000 cells/mm^3
Total lymphocyte count greater than or equal to 800 cells/mm^3
Remaining differential either within institutional normal range or with site physician approval
Platelets equal to 125,000 to 550,000/mm^3
Chemistry:
Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.
Virology:
Negative HIV-1 and -2 blood test: Volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine:
Normal urine:
Negative urine glucose, and
Negative or trace urine protein, and
Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).
Reproductive Status:
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
Condoms (male or female) with or without a spermicide,
Diaphragm or cervical cap with spermicide,
Intrauterine device (IUD),
Hormonal contraception, or
Any other contraceptive method approved by the HVTN 115 Protocol Safety Review Team (PSRT)
Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
Or be sexually abstinent.
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Exclusion Criteria:
General:
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 115 study
Pregnant or breastfeeding
Active duty and reserve U.S. military personnel
Vaccines and Other Injections:
HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 115 PSRT will determine eligibility on a case-by-case basis.
Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 115 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 115 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 115 PSRT on a case-by-case basis.
Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine)
Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System:
Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than 60 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease, current or history
Adverse events of special interest (AESIs)
Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the products administered in this protocol (representative examples are listed in the study protocol)
Immunodeficiency
Clinically Significant Medical Conditions:
Untreated or incompletely treated syphilis infection
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
A process that would affect the immune response,
A process that would require medication that affects the immune response,
Any contraindication to repeated injections or blood draws,
A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
Any condition specifically listed among the exclusion criteria below.
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Asthma exclusion criteria: Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
Uses moderate/high dose inhaled corticosteroids, or
In the past year has either of the following:
Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
Needed emergency care, urgent care, hospitalization, or intubation for asthma.
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months
Hypertension:
If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Wolfe LS, Smedley JG 3rd, Bubna N, Hussain A, Harper R, Mostafa S. Development of a platform-based approach for the clinical production of HIV gp120 envelope glycoprotein vaccine candidates. Vaccine. 2021 Jun 29;39(29):3852-3861. doi: 10.1016/j.vaccine.2021.05.073. Epub 2021 Jun 4.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
FG001
Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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_SAP_ICF
Yes
Yes
Yes
Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Participants will receive CH505TF at Month 0; CH505TF and CH505w53 at Month 2; CH505TF, CH505w53, and CH505w78 at Month 4; CH505w53 and CH505w78 at Month 8. GLA-SE adjuvant is admixed with all the CH505 gp120 proteins.
Biological: CH505TF
Biological: CH505w53
Biological: CH505w78
Biological: GLA-SE adjuvant
Part B: Group 7
Experimental
Participants will receive CH505 M5 (admixed with GLA-SE) at Months 0, 2, 4, and 8.
Biological: CH505 M5
Biological: GLA-SE adjuvant
Part B: Group 8
Placebo Comparator
Participants will receive placebo at Months 0, 2, 4, and 8.
Biological: Placebo
Part C: Group 9
Experimental
Participants will receive CH505TF at Month 0; CH505w53 at Month 2; and CH505w78 at Months 4.
Biological: CH505TF
Biological: CH505w53
Biological: CH505w78
Part B: Group 6
Part C: Group 9
CH505TF gp120
CH505w53
Biological
Administered by IM injection in the thigh
Part B: Group 5
Part B: Group 6
Part C: Group 9
CH505w53 gp120
CH505w78
Biological
Administered by IM injection in the thigh
Part B: Group 5
Part B: Group 6
Part C: Group 9
CH505w78 gp120
CH505 M5
Biological
Administered by IM injection in the thigh
Part B: Group 7
CH505 M5 gp120
GLA-SE adjuvant
Biological
Admixed with all CH505 gp120 proteins
Part A: Group 1
Part A: Group 2
Part A: Group 3
Part B: Group 5
Part B: Group 6
Part B: Group 7
Placebo
Biological
Administered by IM injection in the thigh
Part A: Group 4
Part B: Group 8
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Measured through Month 20
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Measured through the Month 8 boost
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Part B Chemistry and Hematology Laboratory Measures
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11
Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Measured at Month 8.5
Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Measured at Month 8.5
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
Part C: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Measured through Month 16
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Measured through the Month 4 administration
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Part C Chemistry and Hematology Laboratory Measures
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10
Measured at Month 4.5
Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Measured at Month 4.5
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Measured at Month 4.5
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. The reported frequencies are: The % CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells out of total B cells; the % CD4bs CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of total B cells; the % CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells out of IgG+ B cells; and the % CD4bs CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of IgG+ B cells.
Measured at Month 4.5
Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Measured at Month 4.5
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Measured at Months 4.5 and 12.5
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Measured at Months 4.5 and 12.5
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte optical density (OD)) > 3×(background OD) in wells of dilutions 1:30 and 1:90.
Measured at Month 4.5
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule.
Measured at Month 4.5
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Serum HIV-1-specific immunoglobulin G (IgG) responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 2.5 and 8.5
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 2.5 and 8.5
Part B: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part B: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part B: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part B: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Percent B Cells Expressing Candidate CH103 Precursors With Immunogenetics, Function, and Structure Similar to CH103 Lineage Antibodies
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Alterations in Frequency of CH103-like Precursor B Cells Prior to CH505 TF (First) Vaccination and After the Final Vaccination
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Characterization of B-cell Derived Antibodies (Binding, Neutralization and Structure Compared With the CH103 Lineage Members, Including the UCA)
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Measured at Month 4.5
Part C: Frequencies, Specificity and Phenotype of Vaccine-induced B-cell Responses as Measured by Multiparameter Flow Cytometry After Each Vaccination Compared to Baseline
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Characterization of the B-cell Derived Antibodies (Binding of CH505 TF, wk53, wk78 Proteins), Neutralization of Autologous or Mutant CH505 Viruses, and Structure
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
Part C: Response Rate and Magnitude of CD4+ T-cell Responses as Assessed by ICS Assays 2 Weeks After the Final Vaccination
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data
San Francisco
California
94102
United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston
Massachusetts
02115-6110
United States
Columbia P&S CRS
New York
New York
10032-3732
United States
New York Blood Center CRS
New York
New York
10065
United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester
New York
14642
United States
Penn Prevention CRS
Philadelphia
Pennsylvania
19104
United States
Seattle Vaccine and Prevention CRS
Seattle
Washington
98104
United States
FG002
Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
FG003
Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
FG004
Group 5: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
FG005
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF +
FG006
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
FG007
Group 8: Placebo
Placebo(m0,2,4,8)
FG008
Group 9: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG0036 subjects
FG00420 subjects
FG00520 subjects
FG00620 subjects
FG0075 subjects
FG00810 subjects
Month 4.5 Immunogenicity Cohort
FG00011 subjects
FG00112 subjects
FG00212 subjects
FG0033 subjects
FG00419 subjects
FG00520 subjects
FG00619 subjects
FG0074 subjects
FG0089 subjects
COMPLETED
FG0009 subjects
FG00110 subjects
FG00211 subjects
FG0033 subjects
FG00419 subjects
FG00520 subjects
FG00618 subjects
FG0074 subjects
FG00810 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
BG001
Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
BG002
Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
BG003
Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
BG004
Group 5: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
BG005
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF +
BG006
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
BG007
Group 8: Placebo
Placebo(m0,2,4,8)
BG008
Group 9: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG0036
BG00420
BG00520
BG00620
BG0075
BG00810
BG009117
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00032(20 to 48)
BG00131(19 to 49)
BG00227(20 to 48)
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Less than 18 years
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
USA
Title
Measurements
BG00012
BG00112
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
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
Units
Counts
Participants
OG00012
OG00112
OG00212
OG003
Title
Denominators
Categories
Pain
Title
Measurements
None
OG0001
OG0010
OG0022
OG003
Primary
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
Primary
Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Posted
Count of Participants
Participants
Measured through Month 24
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
Units
Counts
Participants
Primary
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Posted
Count of Participants
Participants
Measured through the Month 12 boost
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
Units
Counts
Participants
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
U/L
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
g/dL
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Primary
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
1000 cells per mm^3
Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Primary
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Count of Participants
Participants
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Primary
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Median
Inter-Quartile Range
relative fluorescence units
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Primary
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Count of Participants
Participants
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Primary
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Median
Inter-Quartile Range
relative fluorescence units
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Primary
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8
Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017], The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4
Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Count of Participants
Participants
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Secondary
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. The reported frequencies are: The % CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells out of total B cells; the % CD4bs CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of total B cells; the % CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells out of IgG+ B cells; and the % CD4bs CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of IgG+ B cells.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Median
Inter-Quartile Range
% B-cells
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
Secondary
Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120
Magnitude-breadth characterize the magnitude (ID50) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Only participants with data available for all six isolates are included.
Posted
Mean
Inter-Quartile Range
log10 titer*percentage of isolates
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
Secondary
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Count of Participants
Participants
Measured at Months 4.5 and 12.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
Secondary
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Median
Inter-Quartile Range
% CD4+ T-cells
Measured at Months 4.5 and 12.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
Secondary
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte optical density (OD)) > 3×(background OD) in wells of dilutions 1:30 and 1:90.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Count of Participants
Participants
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
Secondary
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule.
"Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Posted
Median
Inter-Quartile Range
Optical density
Measured at Month 4.5
ID
Title
Description
OG000
Part A, Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
OG001
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
OG002
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
OG003
Part A, Group 4: Placebo
Secondary
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Serum HIV-1-specific immunoglobulin G (IgG) responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
T5-T8 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
T5-T8 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Part B: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part B: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining (ICS) Assays 2 Weeks After the Second and Fourth (Final) Vaccinations With EnvSeq-1 Immunogens or CH505 M5 gp120
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part B: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part B: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Percent B Cells Expressing Candidate CH103 Precursors With Immunogenetics, Function, and Structure Similar to CH103 Lineage Antibodies
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Alterations in Frequency of CH103-like Precursor B Cells Prior to CH505 TF (First) Vaccination and After the Final Vaccination
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Characterization of B-cell Derived Antibodies (Binding, Neutralization and Structure Compared With the CH103 Lineage Members, Including the UCA)
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
T9 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
T9 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Part C: Frequencies, Specificity and Phenotype of Vaccine-induced B-cell Responses as Measured by Multiparameter Flow Cytometry After Each Vaccination Compared to Baseline
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Characterization of the B-cell Derived Antibodies (Binding of CH505 TF, wk53, wk78 Proteins), Neutralization of Autologous or Mutant CH505 Viruses, and Structure
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Part C: Response Rate and Magnitude of CD4+ T-cell Responses as Assessed by ICS Assays 2 Weeks After the Final Vaccination
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
Description
Not provided
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: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
0
12
0
12
4
12
EG001
Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
0
12
1
12
8
12
EG002
Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
0
12
0
12
7
12
EG003
Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
0
6
0
6
4
6
EG004
Group 5: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
0
20
1
20
15
20
EG005
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF +
0
20
0
20
17
20
EG006
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
0
20
0
20
18
20
EG007
Group 8: Placebo
Placebo(m0,2,4,8)
0
5
0
5
3
5
EG008
Group 9: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
0
10
0
10
8
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Event in SOC
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected20 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected10 at risk
Seizure
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Suicidal ideation
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Event in SOC
Blood and lymphatic system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected20 at risk
EG0055 events2 affected20 at risk
EG0060 events0 affected20 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected10 at risk
Lymph node pain
Blood and lymphatic system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Cardiac disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Postural orthostatic tachycardia syndrome
Cardiac disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Congenital, familial and genetic disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Any Event in SOC
Ear and labyrinth disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Endocrine disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypogonadism
Endocrine disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dental caries
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Food poisoning
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
General disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Fatigue
General disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Influenza like illness
General disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Injection site pruritus
General disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Immune system disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Allergy to animal
Immune system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Drug hypersensitivity
Immune system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Seasonal allergy
Immune system disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0003 events3 affected12 at risk
EG0018 events5 affected12 at risk
EG0025 events3 affected12 at risk
EG003
Bacterial vaginosis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bronchitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
COVID-19
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea infectious
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Ear infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Epididymitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Fungal infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Genitourinary chlamydia infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Infectious mononucleosis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Influenza
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site cellulitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Latent syphilis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Onychomycosis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oral herpes
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Otitis externa
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paronychia
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinusitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Sinusitis bacterial
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Suspected COVID-19
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tinea cruris
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tinea versicolour
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tonsillitis
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events4 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Viral infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0018 events4 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatinine increased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood iron decreased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood pressure increased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Full blood count abnormal
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haemoglobin decreased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lymphocyte count decreased
Investigations
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Metabolism and nutrition disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Migraine
Nervous system disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Adjustment disorder with depressed mood
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Depression
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Renal and urinary disorders
MEDRA 24.0
Non-systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Glycosuria
Renal and urinary disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MEDRA 24.0
Non-systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Proteinuria
Renal and urinary disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Reproductive system and breast disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Breast pain
Reproductive system and breast disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0024 events2 affected12 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Any Event in SOC
Social circumstances
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Victim of sexual abuse
Social circumstances
MEDRA 24.0
Non-systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations