Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda
- Conditions
- HIV Infections
- Interventions
- Biological: VRC-HIVDNA009-00-VPBiological: Placebo vaccine
- Registration Number
- NCT01549470
- Brief Summary
Currently, no vaccine prevents HIV infection. This study will test the safety and immune responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.
- Detailed Description
The global HIV/AIDS epidemic continues to increase at unacceptably high levels, and there is not yet an effective prevention method for HIV infection. This study will test the safety and immune responses of a preventive HIV vaccine, VRC-HIVDNA009-00-VP, which is a multiclade HIV-1 DNA plasmid vaccine.
This study will seek to enroll 30 participants, randomly assigning 15 participants each to the study vaccine arm and the placebo vaccine arm. Three doses of the vaccine will be given by intramuscular (IM) injection using the Biojector 2000 needle-free injection management system: the first dose at Day 0 (entry), second dose at Day 28 (within 7 days before or after Day 28), and third dose at Day 56 (within 7 days before or after Day 56). Participants will attend two screening visits and visits at Days 0 (entry), 2, 14, 28, 30, 42, 56, 58, 70, 84, 168, 252, and 336. At most visits, participants will give a medical history and undergo a physical exam, blood draw, and urine collection. For women, a pregnancy test will be given at each study injection visit. Participants also will be instructed to maintain a diary of local and systemic reactions for 7 days after each injection. They also will be provided with a ruler to measure erythema, induration, or other observable reactions and a thermometer to record temperature on a daily basis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study vaccine VRC-HIVDNA009-00-VP Participants in this arm will receive a total of three doses of study vaccine: the first dose at Day 0, the second dose at Day 28 (plus or minus 7 days), and the third dose at Day 56 (plus or minus 7 days). Each dose will consist of a 1-mL injection (dose strength 4 mg/mL) and will be administered by IM injection in the deltoid muscle. Placebo vaccine Placebo vaccine Participants in this arm will receive a total of three doses of a placebo vaccine: the first dose at Day 0, the second dose at Day 28 (plus or minus 7 days), and the third dose at Day 56 (plus or minus 7 days). Each dose will consist of a 1-mL injection and will be administered by IM injection in the deltoid muscle.
- Primary Outcome Measures
Name Time Method Local reactogenicity signs and symptoms Measured through Week 48 visit Systemic reactogenicity signs and symptoms Measured through Week 48 visit Laboratory measures of safety Measured through Week 48 visit HIV-specific cellular immune responses Measured through Week 48 visit As measured by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot) and intracellular cytokine assay using frozen peripheral blood mononuclear cells (PBMCs) and overlapping peptide pools representing the immunogens.
All adverse experiences and serious adverse experiences Measured through Week 48 visit
- Secondary Outcome Measures
Name Time Method Lymphoproliferative responses Measured through Week 48 visit Cytotoxic T lymphocyte (CTL) measured by chromium release assays Measured through Week 48 visit Antibody immune responses as measured by enzyme-linked immunosorbent assay (ELISA) Measured through Week 48 visit Neutralizing antibody assays Measured through Day 70
Trial Locations
- Locations (1)
Makerere University Walter Reed Project (MUWRP)
🇺🇬Kampala, Uganda