Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-unin… (NCT04927585) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-uninfected Adults
United States42 participantsStarted 2021-07-08
Plain-language 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 and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-uninfected adults
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 18 to 50 years
. Access to BWH trial site and willingness to be followed for the planned duration of the study
. Ability and willingness to provide informed consent
. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
. Agrees not to enroll in another study of an investigational research agent
. Good general health as shown by medical history, physical exam, and screening laboratory tests
. Willingness to receive HIV test results
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of local injection site (including DTH) reactogenicity signs and symptoms
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
2
Frequency of systemic reactogenicity signs and symptoms
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
3
Frequency of adverse events (AEs)
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
4
Severity of local injection site (including DTH) reactogenicity signs and symptoms
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
5
Severity of systemic reactogenicity signs and symptoms
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
Exclusion criteria
. Blood products received within 120 days before first vaccination
. Investigational research agents received within 30 days before first vaccination
. Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
. Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing
. Pregnant or breastfeeding
. Active duty and reserve US military personnel Vaccines and other Injections
. HIV vaccine(s) received in a prior HIV vaccine trial.
. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial, unless the vaccine subsequently received regulatory approval or emergency authorization.
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in
7
Number of participants with early discontinuation of vaccinations
Timeframe: Measured through participants' last study visit, at Month 20 to 24, depending on which part of the study participants are enrolled in