A Study to Assess the Safety and Immune Response to Env-C... | NCT04826094 | Trialant
NCT04826094
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Mar 26, 2025Actual
Enrollment
143Actual
Phase
Phase 1
Conditions
HIV Infections
Interventions
Env-C Plasmid DNA
HIV Env gp145 C.6980 protein
Rehydragel®
ALF43
dmLT
Placebo (IM)
Placebo (TCl)
Countries
Kenya
Protocol Section
Identification Module
NCT ID
NCT04826094
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RV460
Secondary IDs
ID
Type
Description
Link
38608
Registry Identifier
DAIDS-ES Registry Number
Brief Title
A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
Official Title
A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of Priming With Env-C Plasmid DNA Vaccine Alone, With Different Adjuvants, or With an Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting With the Adjuvanted HIV Env gp145 C.6980 Protein Vaccine With or Without the Env-C Plasmid DNA Vaccine in Healthy HIV Uninfected Adults in Kenya
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Mar 2023
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
Mar 15, 2021Actual
Primary Completion Date
Feb 13, 2024Actual
Completion Date
Feb 13, 2024Actual
First Submitted Date
Mar 30, 2021
First Submission Date that Met QC Criteria
Mar 30, 2021
First Posted Date
Apr 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Feb 14, 2025
Results First Submitted that Met QC Criteria
Mar 24, 2025
Results First Posted Date
Mar 26, 2025Actual
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
Mar 24, 2025
Last Update Posted Date
Mar 26, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
Walter Reed Army Institute of Research (WRAIR)
FED
US Military HIV Research Program
NETWORK
The Emmes Company, LLC
INDUSTRY
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
This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS).
The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.
Detailed Description
Antibodies are the most commonly recognized correlate of vaccine protection from infection; however the possible protective HIV antibody levels, which were induced by the modestly protective RV144 vaccine regimen with alum, rapidly decayed. Potentially, a novel, highly selective adjuvant combined with the correctly sequenced HIV antigen could slow antibody decay, increase antibody magnitude and induce antibodies of appropriate functional response.
RV460 is an exploratory study that will assess the safety, tolerability, and immunogenicity of a vaccine regimen consisting of priming with an Env-C Plasmid DNA vaccine (with or without novel adjuvants) when given with or without adjuvanted HIV Env gp145 C.6980 protein vaccine and boosting with adjuvanted gp145 C.6980 protein with or without the gp120 DNA vaccine. The study will be carried out in Kericho, Kenya. 126 healthy adults will ben enrolled. Participants will be randomized into one of seven groups which have 15/3 vaccine/placebo recipients per group. Each participant will receive six injections (prim at week 0, 4, 12; boost at week 20, 32 and 56) and will be followed-up for a total of 108 weeks.
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
143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Drug: Placebo (IM)
Group 2: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: ALF43
Drug: Placebo (IM)
Group 3: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: dmLT
Drug: Placebo (IM)
Drug: Placebo (TCl)
Group 4: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: ALF43
Biological: dmLT
Drug: Placebo (IM)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Env-C Plasmid DNA
Biological
2 mg per dose. Administered by intramuscular injection.
Group 1: Vaccine
Group 2: Vaccine
Group 3: Vaccine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 1
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Incidence (number and percentage of participants) of local reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 2
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Incidence (number and percentage of participants) of local reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group.
Day 1-Day 7 Post Vaccination 3
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Incidence (number and percentage of participants) of local reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Day 1-Day 7 Post Vaccination 4
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Incidence (number and percentage of participants) of local reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 5
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Incidence (number and percentage of participants) of local reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Secondary Outcomes
Measure
Description
Time Frame
Magnitude of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Thru Week 105
Durability of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy, male and female participant aged 18 to 40 years and available for 26 months.
Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
Must be able to understand and complete the informed consent process.
Must be capable of reading English or Kiswahili.
Must agree to a home visit.
Must complete a Test of Understanding (TOU) before enrollment. Must answer 9 out of 10 questions correctly with a maximum of three attempts.
Must be in good general health without a clinically significant medical history.
HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
Laboratory values:
Hemoglobin
12.5-18.1 g/dL men
11.0-16.1 g/dL women
White Cell Count
2.7-7.7 x 10³ cells/µL men
3.0-9.1 x 10³ cells/µL women
Platelets:
125-370 10³ cells/µL men
125-444 10³ cells/µL women
ALT and AST: ≤1.25 institutional upper limit of the reference range
Creatinine: ≤1.25 institutional upper limit of the reference range
Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose Female-Specific Criteria
Negative urine pregnancy test for women at screening, the day of each vaccination, and before any invasive procedure.
Already using and commits to continued use of an adequate birth control method for 45 days before to the first vaccination/placebo vaccination, and for at least 90 days after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms with spermicide, diaphragms, intrauterine device (IUD), vasectomy in a monogamous partner, or abstinence.
Lymph Node Biopsy Inclusion Criteria
Body mass index (BMI) <35
Platelets >150,000
International normalized ration (INR) <1.2
Verbal report of no NSAIDS/aspirin for 7 days prior.
Negative pregnancy test for participants born female.
Exclusion Criteria:
A history of:
Three or more sexual partners in the previous 24 weeks.
Commercial sex work.
Non-adherence to condom use in the absence of a long-term monogamous relationship.
Intravenous drug use in the previous year.
A sexually transmitted infection in the previous 24 weeks.
Asplenia: any condition resulting in the absence of a functional spleen.
Bleeding disorder diagnosed by a medical doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
Breastfeeding or pregnant (positive pregnancy test) women or planning to become pregnant during the window between study enrollment and three months after the last vaccination visit.
Any past, ongoing, or in remission history of treated or untreated autoimmune disease.
Has known active Hepatitis B virus infection (or positive HBsAg).
Has known active Hepatitis C infection.
History of anaphylaxis or other serious adverse reaction to vaccines or allergies or reactions likely to be exacerbated by any component of the vaccine and placebo, including antibiotics or excipients.
Absolute Neutrophil Count (ANC) <1.0 x 10³ cells/µL.
Participant has received any of the following substances:
Chronic use of therapies that may modify immune response, such as intravenous (IV) immune globulin and systemic corticosteroids (in doses of >20 mg/day prednisone equivalent for periods exceeding 10 days).
The following exceptions are permitted and will not exclude study participation:
Use of corticosteroid nasal spray for rhinitis;
Topical corticosteroids for an acute uncomplicated dermatitis; or
A short course (10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks before enrollment.
Blood products within 120 days before HIV screening.
Immunoglobulins within 30 days before HIV screening.
Any experimental vaccine containing an adjuvant other than aluminum of an adjuvant not approved by the FDA or European Medicines Agency (EMA) as part of a licensed vaccine.
CERVARIX vaccine against HPV (containing AS04)
Receipt of any investigational HIV vaccine, investigational research agents or vaccine within 30 days before enrollment.
Anti-tuberculosis prophylaxis or therapy during the past 90 days before enrollment.
Any psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol compliance or impairs a participant's ability to give informed consent.
Major psychiatric illness and or substance abuse problems during the past 12 months that, in the opinion of the investigator, would preclude participation.
History of atopy or significant skin conditions.
Study site employees who are involved in the protocol and or may have direct access to the study-related area.
Lymph Node Biopsy Exclusion Criteria
History of keloid formation.
History of an inguinal hernia, inguinal canal cryptorchidism, varicocele, hydrocele.
History of inguinal excisional lymph node biopsy.
Final evaluation of eligibility is based on the medical judgment of the investigator. The Protocol Safety Review Team will also remain available to the investigator for consultation if desired.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
40 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Josphat Kosgei, MBChB, MSc
Kenya Medical Research Institute/US Medical Research Directorate-Africa
Principal Investigator
Christina Polyak, MD
U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)
Study Chair
Sandhya Vasan, MD
U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Kenya Medical Research Institute/Walter Reed Project, Clinical Research Centre, Off Hospital Road
Kericho
Kenya
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
See protocol for screening details.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: ALF43
Drug: Placebo (IM)
Group 6: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: ALF43
Drug: Placebo (IM)
Group 7: Vaccine
Experimental
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Biological: Env-C Plasmid DNA
Biological: HIV Env gp145 C.6980 protein
Drug: Rehydragel®
Biological: ALF43
Drug: Placebo (IM)
Pooled Placebo
Placebo Comparator
Pooled placebo arm.
Drug: Placebo (TCl)
Group 4: Vaccine
Group 5: Vaccine
Group 6: Vaccine
Group 7: Vaccine
HIV Env gp145 C.6980 protein
Biological
100 µg per dose. Administered by intramuscular injection.
Group 1: Vaccine
Group 2: Vaccine
Group 3: Vaccine
Group 4: Vaccine
Group 5: Vaccine
Group 6: Vaccine
Group 7: Vaccine
Rehydragel®
Drug
Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
Group 1: Vaccine
Group 2: Vaccine
Group 3: Vaccine
Group 4: Vaccine
Group 5: Vaccine
Group 6: Vaccine
Group 7: Vaccine
ALF43
Biological
Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Group 2: Vaccine
Group 4: Vaccine
Group 5: Vaccine
Group 6: Vaccine
Group 7: Vaccine
dmLT
Biological
Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Group 3: Vaccine
Group 4: Vaccine
Placebo (IM)
Drug
0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Group 1: Vaccine
Group 2: Vaccine
Group 3: Vaccine
Group 4: Vaccine
Group 5: Vaccine
Group 6: Vaccine
Group 7: Vaccine
Placebo (TCl)
Drug
Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
Group 3: Vaccine
Group 4: Vaccine
Pooled Placebo
Day 1-Day 7 Post Vaccination 6
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 1
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 2
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group
Day 1-Day 7 Post Vaccination 3
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Day 1-Day 7 Post Vaccination 4
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Day 1-Day 7 Post Vaccination 5
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Day 1-Day 7 Post Vaccination 6
Number of Related Unsolicited AEs (Outcome 13)
Incidence (number and percentage of participants) of related unsolicited AEs by maximum severity and vaccination group.
Day 1-Day 728
Number of SAEs (Outcome 14)
Incidence (number and percentage of participants) of SAEs by maximum severity and vaccination group
Day 1-Day 728
Measured by binding antibody assays.
Thru Week 105
Area Under the Curve (AUC) for Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Thru Week 105
Magnitude of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Thru Week 105
Durability of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Thru Week 105
AUC for Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Thru Week 105
Presence of Plasma IgG Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Thru Week 105
Presence of Plasma IgA Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Thru Week 105
Types of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Thru Week 105
Level of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Thru Week 105
Types of Mucosal Humoral Responses
Including, but not limited to, plasma IgG and IgA binding antibodies to HIV Env proteins, IgG and IgA subclass, and functional assays.
Thru Week 104
FG001
Group 2: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
FG003
Group 4: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
FG00017 subjects
FG00116 subjects
FG00217 subjects
FG00316 subjects
FG00416 subjects
FG00518 subjects
FG00617 subjects
FG00726 subjects
COMPLETED
FG00013 subjects
FG00114 subjects
FG00215 subjects
FG00315 subjects
FG00413 subjects
FG00512 subjects
FG00614 subjects
FG00720 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG0043 subjects
FG0056 subjects
FG0063 subjects
FG0076 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0061 subjects
FG0071 subjects
Participant withdrew consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Non-adherence (protocol deviation)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawn by Investigator
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other: Moved from area
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Other: Declined
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other: Vaccine not administered
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
All Randomized Participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG001
Group 2: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG002
Group 3: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG003
Group 4: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG004
Group 5: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG005
Group 6: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG006
Group 7: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
BG007
Pooled Placebo
Pooled placebo arm.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00017
BG00116
BG00217
BG00316
BG00416
BG00518
BG00617
BG00726
BG008143
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
All Randomized Participants
Mean
Standard Deviation
years
Title
Denominators
Categories
Age Years
Title
Measurements
BG00026.4± 3.7
BG00126.6± 5.3
BG00229.0± 4.5
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-25
BG0008
BG0018
BG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
BMI
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
Title
Measurements
BG00024.05± 5.13
BG00122.49± 4.73
BG002
Tribe
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Kalenjin
BG00012
BG00115
BG002
Marital Status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Single, never married
BG0006
BG0018
BG002
Level of Education
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
No formal education
BG0000
BG0010
BG002
Primary Occupation
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Student
BG0002
BG0012
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
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 1
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
OG004
Pooled Placebo
Pooled Placebo
OG005
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
Units
Counts
Participants
OG00033
OG00132
OG00233
OG003
Title
Denominators
Categories
Any Solicited Local Reactogenicity Event
Title
Measurements
None
OG00023
OG00127
OG00225
OG003
Primary
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Incidence (number and percentage of participants) of local reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 2
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
Primary
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Incidence (number and percentage of participants) of local reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group.
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 3
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
Primary
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Incidence (number and percentage of participants) of local reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 4
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Incidence (number and percentage of participants) of local reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 5
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Incidence (number and percentage of participants) of local reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 6
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 1
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
Primary
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 2
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
Primary
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 3
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
OG002
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
OG003
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
Primary
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 4
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 5
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 7 Post Vaccination 6
ID
Title
Description
OG000
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®
OG001
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG002
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel
Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 protein / Rehydragel
OG003
Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43
Primary
Number of Related Unsolicited AEs (Outcome 13)
Incidence (number and percentage of participants) of related unsolicited AEs by maximum severity and vaccination group.
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 728
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel
OG002
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG003
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Primary
Number of SAEs (Outcome 14)
Incidence (number and percentage of participants) of SAEs by maximum severity and vaccination group
The safety population includes all participants who received at least one vaccination.
Posted
Count of Participants
Participants
Day 1-Day 728
ID
Title
Description
OG000
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
OG001
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel
Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel
OG002
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43
Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 protein / Rehydragel®/ ALF43
OG003
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
Secondary
Magnitude of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
Durability of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
Area Under the Curve (AUC) for Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
Magnitude of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
Durability of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
AUC for Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Not Posted
Thru Week 105
Participants
Secondary
Presence of Plasma IgG Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Not Posted
Thru Week 105
Participants
Secondary
Presence of Plasma IgA Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Not Posted
Thru Week 105
Participants
Secondary
Types of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Not Posted
Thru Week 105
Participants
Secondary
Level of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Not Posted
Thru Week 105
Participants
Secondary
Types of Mucosal Humoral Responses
Including, but not limited to, plasma IgG and IgA binding antibodies to HIV Env proteins, IgG and IgA subclass, and functional assays.
Not Posted
Thru Week 104
Participants
Time Frame
AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
Description
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
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
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
17
1
17
15
17
EG001
Group 2: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
16
0
16
15
16
EG002
Group 3: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
16
0
16
14
16
EG003
Group 4: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
16
0
16
13
16
EG004
Group 5: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
16
0
16
13
16
EG005
Group 6: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
17
0
17
13
17
EG006
Group 7: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
0
16
0
16
13
16
EG007
Pooled Placebo
Pooled placebo arm.
0
23
0
23
17
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (25.0)
Non-systematic Assessment
Type 1 diabetes mellitus
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG0030 events0 affected16 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0022 events2 affected16 at risk
EG0032 events2 affected16 at risk
EG0042 events1 affected16 at risk
EG0050 events0 affected17 at risk
EG0065 events3 affected16 at risk
EG0071 events1 affected23 at risk
Leukopenias NEC
Blood and lymphatic system disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Medra
Non-systematic Assessment
EG0003 events3 affected17 at risk
EG0010 events0 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Excessive cerumen production
Ear and labyrinth disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Graves' disease
Endocrine disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Constipation
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Dental caries
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Enteritis
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Gastritis
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0003 events3 affected17 at risk
EG0012 events2 affected16 at risk
EG0023 events3 affected16 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Haematochezia
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Odynophagia
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Proctalgia
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Stomatitis
Gastrointestinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Toothache
General disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Chest pain
General disorders
Medra
Non-systematic Assessment
EG0002 events2 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Chills
General disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Fatigue
General disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Pyrexia
General disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Swelling
General disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Tenderness
General disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Amoebiasis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Bacterial vaginosis
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Bronchitis
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Conjunctivitis
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Extrapulmonary tuberculosis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Gastroenteritis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Helicobacter infection
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Malaria
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Pharyngitis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Pneumonia
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Rhinitis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0013 events3 affected16 at risk
EG0022 events1 affected16 at risk
EG003
Septic rash
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Sinusitis
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Tonsillitis
Infections and infestations
Medra
Non-systematic Assessment
EG0003 events3 affected17 at risk
EG0016 events6 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Medra
Non-systematic Assessment
EG0006 events5 affected17 at risk
EG00112 events10 affected16 at risk
EG0026 events4 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0012 events2 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Vaginal infection
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Wound infection
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Wound infection bacterial
Infections and infestations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0011 events1 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0013 events3 affected16 at risk
EG0023 events2 affected16 at risk
EG003
Wound
Injury, poisoning and procedural complications
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0023 events3 affected16 at risk
EG003
Blood creatinine increased
Investigations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected16 at risk
EG0024 events3 affected16 at risk
EG003
International normalised ratio increased
Investigations
Medra
Non-systematic Assessment
EG0002 events2 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Lymphocyte count decreased
Investigations
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Prothrombin time prolonged
Investigations
Medra
Non-systematic Assessment
EG0004 events4 affected17 at risk
EG0011 events1 affected16 at risk
EG0022 events2 affected16 at risk
EG003
White blood cell count decreased
Investigations
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0012 events2 affected16 at risk
EG0022 events2 affected16 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0014 events3 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Dizziness
Nervous system disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Headache
Nervous system disorders
Medra
Non-systematic Assessment
EG0004 events4 affected17 at risk
EG0016 events6 affected16 at risk
EG0026 events4 affected16 at risk
EG003
Neuropathy peripheral
Nervous system disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Ovarian disorder
Reproductive system and breast disorders
Medra
Non-systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Allergic cough
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected16 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected16 at risk
EG003
Hypertension
Vascular disorders
Medra
Non-systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected16 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
David Fetterer, MS (Programmer Analyst)
Henry M Jackson Foundation for the Advancement of Military Medicine