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 range18 Years – 50 Years
SexALL
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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
✓. 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
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
6
Severity 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
✕. 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.
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