A Phase 1 interventional study of VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Diagnostic
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
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:
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 114 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)