Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults
Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A, B, C, A/E) / Gag (C) DNA and gp120 (A, B, C, A/E) Protein HIV-1 Vaccines (PDPHV) With Either Alhydrogel or GLA-SE in Healthy Adults Living Without HIV
1 other identifier
interventional
126
2 countries
2
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA prime and gp120 (A,B,C,A/E) protein HIV-1 vaccines boost (PDPHV) with either Alhydrogel or GLA-SE in healthy, HIV-uninfected adults. Volunteers will receive either the PDPHV or the placebo (normal saline) by intramuscular injections. Some volunteers will receive Alhydrogel and others will receive GLA-SE as part of the protein boost.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2026
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
Study Completion
Last participant's last visit for all outcomes
August 1, 2029
June 30, 2026
June 1, 2026
2 years
June 9, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Frequency of local injection site (including DTH) reactogenicity signs and symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Frequency of systemic reactogenicity signs and symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Frequency of adverse events (AEs)
AEs categorized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class, MedDRA preferred term, severity, and assessed relationship to study products
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Severity of local injection site (including DTH) reactogenicity signs and symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Severity of systemic reactogenicity signs and symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Severity of adverse events (AEs)
AEs categorized by MedDRA system organ class, MedDRA preferred term, severity, and assessed relationship to study products
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Number of participants with early discontinuation of vaccinations
Tabulated by reason and treatment arm
Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Magnitude of serum HIV-1 Env-specific IgG responses
Assessed by ELISA or Binding Antibody Multiplex Assay
Measured at 2 weeks after the last vaccination at month 6.5
Breadth of gp70-V1V2 IgG and gp120 IgA
Assessed by ELISA or Binding Antibody Multiplex Assay.
Measured at 2 weeks after the last vaccination at month 6.5
ADCC activities
Assessed by GranToxiLux assay
Measured at 2 weeks after the last vaccination at month 6.5
Secondary Outcomes (2)
Serum neutralizing antibody responses against Tier 1A, Tier 1B, and selected Tier 2 viruses
Measured at 2 weeks after the last vaccination at month 6.5
Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses
Measured at 2 weeks after the last vaccination at month 6.5
Study Arms (10)
Group 1 (Treatment): Protein Vaccines/Alhydrogel
EXPERIMENTALParticipants will receive 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel adjuvant to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 0 and 3.
Group 1 (Control)
PLACEBO COMPARATORParticipants will receive Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost
EXPERIMENTALParticipants will receive 2000 mcg Plasmid DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0 and 1; and 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 2 (Control)
PLACEBO COMPARATORParticipants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0 and 1; And Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE
EXPERIMENTALParticipants will receive 2000 mcg Plasmid DNA Vaccine to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, and 1; and 400 mcg Recombinant Protein Vaccines admixed with 5 mcg GLA-SE, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 3 (Control)
PLACEBO COMPARATORParticipants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, and 1; and Placebo to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost
EXPERIMENTALParticipants will receive 2000 mcg Plasmid DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, 1, 3, and 6; and 400 mcg Recombinant Protein Vaccines admixed with 800 mcg Alhydrogel, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 4 (Control)
PLACEBO COMPARATORParticipants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, 1, 3, and 6; and Placebo for to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost
EXPERIMENTALParticipants will receive 2000 mcg Plasmids DNA Vaccines to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at months 0, 1, 3, and 6; and 400 mcg Recombinant Protein Vaccines admixed with 5 mcg GLA-SE, to be administered as a 1 mL (IM) injection in the deltoid of the NON-DOMINANT arm at months 3 and 6.
Group 5 (Control)
PLACEBO COMPARATORParticipants will receive Placebo to be administered as a 0.8 mL (IM) injection in the deltoid of the DOMINANT arm at Months 0, 1, 3, and 6; and Placebo to be administered as a 0.9 mL (IM) injection into the deltoid of the NON-DOMINANT arm at months 3 and 6.
Interventions
The polyvalent DNA Vaccines contains equal amounts of 5 individual DNA plasmid components utilizing the same vector pSW3891. Four plasmids each containing a codon optimized gp120 gene sequence from HIV-1 subtype A, B, C and CRF01\_AE consensus, and a fifth plasmid containing a codon optimized gag gene from subtype C.
The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.
PDPHV protein vaccines adjuvant
PDPHV protein vaccines adjuvant
Sodium Chloride for Injection, USP 0.9%.
Eligibility Criteria
You may qualify if:
- Age of 18 to 55 years
- Access to a trial site and willingness to be followed for the planned duration of the study.
- Ability and willingness to provide informed consent
- Demonstrates an understanding of the study
- Agrees not to enroll in another study of an investigational research agent
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- 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.
- Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 12.0 g/dL for volunteers who were born male
- White blood cell count = 3,000 to 12,000 cells/mm3
- Total lymphocyte count \> 800 cells/mm3
- Remaining differential either within institutional normal range or with site physician approval
- Platelets = 125,000 to 450,000/mm3
- Chemistry panel: ALT\< 1.25 times the institutional upper limit of normal; creatinine \< 1.1 times institutional upper limit of normal.
- +13 more criteria
You may not qualify if:
- Blood products received within 120 days before first vaccination.
- Investigational research agents received within 30 days before first vaccination.
- Body mass index (BMI) ≥ 40.
- Intent to participate in another study of an investigational research agent or any other study that requires HIV antibody testing.
- Pregnant or breastfeeding.
- Active duty and reserve US military personnel.
- HIV vaccine(s) received in a prior HIV vaccine trial.
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial unless the vaccine subsequently received regulatory approval or emergency authorization.
- Live attenuated vaccines, other than the influenza vaccine, received within 30 days before first vaccination or scheduled within 14 days after injection.
- Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination.
- Allergy treatment with antigen injections within 30 days before the first vaccination or those that are scheduled within 14 days after the first vaccination
- Immunosuppressive medications received within 168 days before the first vaccination.
- Serious adverse reactions to vaccines or to vaccine components, including a history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
- Immunoglobulin received within 60 days before the first vaccination.
- Immunodeficiency.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Worcester HIV Vaccinelead
- Desmond Tutu Health Foundationcollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Emavundleni Clinical Research Site, Desmond Tutu Health Foundation
Cape Town, South Africa
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Conasagrie Nair, PhD, MD
Desmond Tutu Health Foundation
- PRINCIPAL INVESTIGATOR
Stephen Walsh, PhD, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2026
First Posted
June 30, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 1, 2029
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Data obtained through this study may be provided to qualified researchers with academic interest. Data will be deidentified, and access requires approval of a research proposal, execution of a Data Sharing Agreement, and IRB approval. Requests can be submitted starting 9 months after publication and will be available for up to 24 months.