HIV PreventionPhase 2NCT07675629

Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults

A Phase 2 study testing PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) and Alhydrogel adjuvant in people with HIV Prevention, run by Worcester HIV Vaccine at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV Prevention
What is being tested?: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) and Alhydrogel adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 2 sitesin 2 countries
Study dates: 1 Sep 2026to Aug 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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.
Negative HIV-1 and -2 blood test
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV)
Urinalysis
Negative or trace urine glucose, and
Negative or trace urine protein, and
Negative, trace, or 1+ urine hemoglobin (if 1+ hemoglobin is present on dipstick in the absence of menstruation, a microscopic urinalysis with red blood cells morphology within institutional normal range)
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β HCG) pregnancy test performed prior to vaccination on the day of initial vaccination.
Reproductive status: A volunteer who was born female must:
Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until at least 3 months after last vaccination.;
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 (verified by medical records where available, or based on the judgement of the local investigator);
Or have no male sexual partner.
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination, or in vitro fertilization until at least 3 months after last vaccination.

Who cannot join

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.

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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.
Autoimmune disease, connective tissue disease, or history of vasculitis. A volunteer with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Not exclusionary: (1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms; (2) mild psoriasis or other mild, uncomplicated, localized or dermatologic condition that does not require ongoing systemic treatment; (3) remote history (>10 years ago) of Kawasaki disease without sequelae; and (4) celiac disease well controlled for 6 months with diet only.
Immunodeficiency.
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health as per the investigator's judgement.
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 other than mild, well-controlled asthma
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Uncontrolled thyroid disease, recent thyroidectomy, or new onset hypothyroidism or hyperthyroidism, defined as new or changing doses of thyroid medication within 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 (defined as ≥ 90 mmHg diastolic or ≥ 140 mmHg systolic after 10 minutes' rest).
If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 140 mm Hg at enrollment or diastolic blood pressure ≥ 90 mm Hg at enrollment. One repeat attempt at measurement on a different date is allowed.
Bleeding disorder diagnosed by a doctor.
Malignancy.
Seizure disorder: History of seizure(s) within past three years.
Asplenia: any condition resulting in the absence of a functional spleen.
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Project manager contact

508-282-9447

WHV.doc@whvaccine.com

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Stephen Walsh

Other trials in United States

South Africa1 site

Emavundleni Clinical Research Site, Desmond Tutu Health Foundation
Cape Town
Conasagrie Nair

Other trials in South Africa

About this study

Official title: 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

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.

Read the detailed description

Participants will be enrolled in Group 1 to group 5. Within each group, participants will be randomly assigned to either Treatment or Placebo Control.

Group 1 (Sentinel group) will be enrolled first to test the safety of the protein vaccines mixed with the Alhydrogel adjuvant. Participants in Group 1 (Treatment) will receive polyvalent gp120 (A, B, C, A/E) protein vaccines mixed with Alhydrogel in the non-dominant arm at months 0, and 3. Participants in Group 1 (Control) will receive placebo at months 0, and 3.

The Safety Monitoring Board (SMB) will evaluate the safety profile of volunteers in Group 1 in two weeks after the 2nd dose. The Alhydrogel adjuvanted Protein Vaccines boosts in group 2 and group 4 can only proceed after SMB reviews the safety data from Group 1 and approves to the use of Alhydrogel in these studies.

Participants in Group 2 (Treatment) will receive env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at months 0, and 1, followed by gp120 (A, B, C, A/E) Protein Vaccines mixed with Alhydrogel boosts in the non-dominant arm at Months 3, and 6. Participants in Group 2 (Control) will receive placebo at Months 0, 1, 3, and 6.

Participants in Group 3 (Treatment) will receive env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at months 0, and 1, followed by gp120 (A, B, C, A/E) Protein Vaccines mixed with GLA-SE boosts in the non-dominant arm at Months 3, and 6. Participants in Group 3 (Control) will receive placebo at Months 0, 1, 3, and 6.

Participants in Group 4 (Treatment) will receive env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at months 0, and 1, followed by gp120 (A, B, C, A/E) Protein Vaccines mixed with Alhydrogel boosts in the non-dominant arm AND env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at Months 3, and 6. Participants in Group 4 (Control) will receive placebo at Months 0, 1, 3, and 6.

Participants in Group 5 (Treatment) will receive env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at months 0, and 1, followed by gp120 (A, B, C, A/E) Protein Vaccines mixed with GLA-SE boosts in the non-dominant arm AND env (A, B, C, A/E)/gag (C) DNA Vaccines in the dominant arm at Months 3, and 6. Participants in Group 5 (Control) will receive placebo at Months 0, 1, 3, and 6.

Study visits for participants in Group 1 will occur at Months 0, 0.5, 3, 3.5, 6, 9, and 15. Study visits for participants in Group 2 to Group 5 will occur at Monthes 0, 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 12 and 18. Visits may include physical examination, blood and urine collection, HIV testing, risk reduction counselling, and questionnaires.

Conditions: HIV Prevention
Being tested: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Alhydrogel adjuvant, GLA-SE adjuvant, Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Keywords: HIV-1, vaccine, antibody, human study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))Biological
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.
PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))Biological
The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.
Alhydrogel adjuvantBiological
PDPHV protein vaccines adjuvant
GLA-SE adjuvantBiological
PDPHV protein vaccines adjuvant
Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsBiological
Sodium Chloride for Injection, USP 0.9%.

Study groups in NCT07675629
Study group	Role	What they receive
Group 1 (Treatment): Protein Vaccines/Alhydrogel	Experimental	Participants 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. Receives: Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)); Biological: Alhydrogel adjuvant
Group 1 (Control)	Placebo comparator	Participants 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. Receives: Biological: Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost	Experimental	Participants 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. Receives: Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)); Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)); Biological: Alhydrogel adjuvant
Group 2 (Control)	Placebo comparator	Participants 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. Receives: Biological: Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE	Experimental	Participants 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. Receives: Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)); Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)); Biological: GLA-SE adjuvant
Group 3 (Control)	Placebo comparator	Participants 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. Receives: Biological: Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost	Experimental	Participants 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. Receives: Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)); Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)); Biological: Alhydrogel adjuvant
Group 4 (Control)	Placebo comparator	Participants 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. Receives: Biological: Placebo for DNA Vaccines, Protein Vaccines and Adjuvants
Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost	Experimental	Participants 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. Receives: Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)); Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)); Biological: GLA-SE adjuvant
Group 5 (Control)	Placebo comparator	Participants 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. Receives: Biological: Placebo for DNA Vaccines, Protein Vaccines and Adjuvants

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at 2 weeks after the last vaccination at month 6.5
ADCC activities
Assessed by GranToxiLux assay
Measured: 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
Assessed by TZM-bl assay
Measured: Measured at 2 weeks after the last vaccination at month 6.5
Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses
Assessed by intracellular cytokine staining (ICS)
Measured: Measured at 2 weeks after the last vaccination at month 6.5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2026Aug 2029

First posted30 Jun 2026
Study start1 Sep 2026 (estimated)
Primary completion31 Aug 2028 (estimated)
Study completionAug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 126 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07675629
Sponsor's protocol ID: WHV238
Status last verified: Jun 2026
First submitted: 9 Jun 2026
Last updated: 30 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

Project manager

508-282-9447

WHV.doc@whvaccine.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07675629
Acronym / sponsor ID: WHV238
Conditions: HIV Prevention
Keywords: HIV-1, vaccine, antibody, human study
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 126 participants (estimated)
Lead sponsor: Worcester HIV VaccineIndustry (pharma, biotech, devices)
Collaborators: Desmond Tutu Health Foundation, Brigham and Women's Hospital
Study start: 1 Sep 2026 (estimated)
Primary completion: 31 Aug 2028 (estimated)
Study completion: Aug 2029 (estimated)
First posted: 30 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will be enrolled in Group 1 to group 5. Within each group, participants will be randomly assigned to either Treatment or Placebo Control.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Group 1 (Treatment): Protein Vaccines/Alhydrogel	Experimental	Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Biological: Alhydrogel adjuvantParticipants 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 comparator	Biological: Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsParticipants 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	Experimental	Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Biological: Alhydrogel adjuvantParticipants 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 comparator	Biological: Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsParticipants 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	Experimental	Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Biological: GLA-SE adjuvantParticipants 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 comparator	Biological: Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsParticipants 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	Experimental	Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Biological: Alhydrogel adjuvantParticipants 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 comparator	Biological: Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsParticipants 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	Experimental	Biological: PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), Biological: PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Biological: GLA-SE adjuvantParticipants 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 comparator	Biological: Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (28 listed)

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

Key exclusion criteria (31 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))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.	Biological	Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost, Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE, Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost, Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost
PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))The Recombinant Protein Vaccines (gp120 (A, B, C, A/E)) contains equal amounts of 4 gp120 proteins.	Biological	Group 1 (Treatment): Protein Vaccines/Alhydrogel, Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost, Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE, Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost, Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost
Alhydrogel adjuvantPDPHV protein vaccines adjuvant	Biological	Group 1 (Treatment): Protein Vaccines/Alhydrogel, Group 2 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel boost, Group 4 (Treatment): DNA Vaccines prime, Protein Vaccines/Alhydrogel + DNA Vaccines boost
GLA-SE adjuvantPDPHV protein vaccines adjuvant	Biological	Group 3 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE, Group 5 (Treatment): DNA Vaccines prime, Protein Vaccines/GLA-SE + DNA vaccines boost
Placebo for DNA Vaccines, Protein Vaccines and AdjuvantsSodium Chloride for Injection, USP 0.9%.	Biological	Group 1 (Control), Group 2 (Control), Group 3 (Control), Group 4 (Control), Group 5 (Control)

Primary outcome

Frequency of local injection site (including DTH) reactogenicity signs and symptoms
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Frequency of systemic reactogenicity signs and symptoms
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Frequency of adverse events (AEs)
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
AEs categorized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class, MedDRA preferred term, severity, and assessed relationship to study products
Severity of local injection site (including DTH) reactogenicity signs and symptoms
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Severity of systemic reactogenicity signs and symptoms
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Severity of adverse events (AEs)
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
AEs categorized by MedDRA system organ class, MedDRA preferred term, severity, and assessed relationship to study products
Number of participants with early discontinuation of vaccinations
Time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
Tabulated by reason and treatment arm
Magnitude of serum HIV-1 Env-specific IgG responses
Time frame: Measured at 2 weeks after the last vaccination at month 6.5
Assessed by ELISA or Binding Antibody Multiplex Assay
Breadth of gp70-V1V2 IgG and gp120 IgA
Time frame: Measured at 2 weeks after the last vaccination at month 6.5
Assessed by ELISA or Binding Antibody Multiplex Assay.
ADCC activities
Time frame: Measured at 2 weeks after the last vaccination at month 6.5
Assessed by GranToxiLux assay

2 secondary outcomes

Serum neutralizing antibody responses against Tier 1A, Tier 1B, and selected Tier 2 viruses
Time frame: Measured at 2 weeks after the last vaccination at month 6.5
Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses
Time frame: Measured at 2 weeks after the last vaccination at month 6.5

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Project manager contact

508-282-9447

WHV.doc@whvaccine.com

Conasagrie Nair, PhD, MD principal investigator

Desmond Tutu Health Foundation

Stephen Walsh, PhD, MD principal investigator

Brigham and Women's Hospital

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project manager (508-282-9447, WHV.doc@whvaccine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of local injection site (including DTH) reactogenicity signs and symptoms (time frame: Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07675629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.