Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.
Biological: Vaccine placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Phase II, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection|
- Safety and tolerability, as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- immunogenicity as assessed by the proportion of participants who develop HIV-specific T-cell responses and/or to ENV A-, B-, or C-specific antibodies and magnitude of those responses [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Recruitment, enrollment, and retention rates by gender and risk category for participating trial sites [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- safety, tolerability, and immunogenicity endpoints in participants with varying pre-existing immunity to adenovirus [ Time Frame: throughout study ] [ Designated as safety issue: No ]
DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6.
|Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP|
Placebo Comparator: B
Biological: Vaccine placebo
Due to the availability of antiretroviral therapy, AIDS-related deaths have lessened in the United States. However, these therapies are widely inaccessible to the developing world. The need for a safe and affordable vaccine that will prevent HIV infection is of utmost importance. To generate a broadly protective vaccine, it is necessary to develop a multivalent vaccine containing a defined combination of immunogens from the most globally prevalent HIV subtypes. This study will evaluate the safety, tolerability, and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine,VRC-HIVDNA016-00-VP, followed by a multiclade recombinant HIV-1 adenoviral vector vaccine, HIVADV014-00-VP.
This study will last about 27 months. Participants will be randomly assigned to one of two groups. Group A will receive the DNA vaccine at baseline, Month 1, and Month 2, and the adenoviral vector vaccine at Month 6; Group B will receive placebo. There will be 20 study visits over 2 years. Physical exams, vital signs measurements, adverse event evaluation, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
|Study Chair:||Pontiano Kaleebu, MD, PhD||Medical Research Council/Uganda Viral Research Institute (UVRI) Uganda Research Unit on AIDS, UVRI/International AIDS Vaccine Initiative HIV Vaccine Program|