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Evaluating the PDPHV HIV Vaccine for Prevention

This study is testing a new vaccine called PDPHV, which combines DNA and protein parts, to see if it can help prevent HIV in healthy adults who do not have HIV. Researchers want to understand how safe the vaccine is and how well it helps the body create an immune response against HIV. You might receive the PDPHV vaccine or a placebo (a harmless substance like salt water). Some participants will also receive different boosters called Alhydrogel or GLA-SE. The study aims to enroll 126 adults between 18 and 55 years old. The main goal is to track any side effects and how your body reacts to the vaccine over 15 to 18 months.

Study design
This interventional study will enroll 126 healthy adults, randomly assigning them to receive either the PDPHV vaccine or a placebo. There are multiple groups, with some receiving different vaccine components and adjuvants (substances that boost the immune response).
What's involved
You would receive injections at different times over several months and be followed for 15 to 18 months. The study involves multiple visits for these injections and to monitor your health.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through their last study visit, which will be at Month 15 or Month 18, depending on the study group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07675629

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

Not Yet Recruiting
PHASE2Ages 18–55InterventionalPrevention
Worcester HIV Vaccine
~126 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C))PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E))Alhydrogel adjuvantGLA-SE adjuvantPlacebo for DNA Vaccines, Protein Vaccines and Adjuvants

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of local injection site (including DTH) reactogenicity signs and symptoms
Measured over Measured through participants' last study visit, at Month 15 or 18, depending on which part of the study participants are enrolled in
+9 more outcomes measured

Conditions

HIV Prevention

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Where it's being run

2 sites across 2 states
Massachusetts1
South Africa1

Study leadership

  • Conasagrie Nair, PhD, MD · PRINCIPAL_INVESTIGATOR · Desmond Tutu Health Foundation
  • Stephen Walsh, PhD, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Project manager
[email protected]
508-282-9447
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) 20. 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. 21. 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. 22. 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.

Exclusion

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. 25. Bleeding disorder diagnosed by a doctor. 26. Malignancy. 27. Seizure disorder: History of seizure(s) within past three years. 28. Asplenia: any condition resulting in the absence of a functional spleen. 29. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

What this trial measures

  • Frequency of local injection site (including DTH) reactogenicity signs and symptomsMeasured 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 symptomsMeasured 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)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 symptomsMeasured 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 symptomsMeasured 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)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 vaccinationsMeasured 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 responsesMeasured 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 IgAMeasured at 2 weeks after the last vaccination at month 6.5

    Assessed by ELISA or Binding Antibody Multiplex Assay.

  • ADCC activitiesMeasured at 2 weeks after the last vaccination at month 6.5

    Assessed by GranToxiLux assay