Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
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|ClinicalTrials.gov Identifier: NCT00124007|
Recruitment Status : Completed
First Posted : July 26, 2005
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: VRC-HIVADV014-00-VP Biological: VRC-HIVDNA016-00-VP||Phase 1|
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.
Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
- Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
- Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase I, 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 or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV|
|Study Start Date :||November 2005|
|Study Completion Date :||April 2007|
- Local reactogenicity signs and symptoms
- systemic reactogenicity signs and symptoms
- laboratory measures of safety
- adverse and serious adverse experiences
- Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
- proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
- proportion of volunteers with increase in antibodies to rAd5
- impact of pre-existing immunity to rAd5 on immunogenicity
- proportion of volunteers who test "false positive" on standard HIV testing algorithm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124007
|KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi|
|KAVI, KNH at Kangemi|
|Projet San Francisco|
|Principal Investigator:||Job Bwayo, MD, PhD||Kenya AIDS Vaccine Initiative, University of Nairobi|
|Principal Investigator:||Etienne Karita, MD||Project San Francisco|