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
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
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Listed as NCT00124007, this PHASE1 trial focuses on HIV Infections and remains completed. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 8 times since 2005, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Study Description(click to expand)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...
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Dec 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jan 2021 — Dec 2021 [monthly]
Completed PHASE1
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Nov 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Allergy and Infectious Diseases (NIAID)
For direct contact, visit the study record on ClinicalTrials.gov .