At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 326 enrolled
Drug / intervention
VRC-HIVDNA016-00-VP +3 morebiological
Likely dose
VRC-HIVADV014-00-VP 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 26, 2005·Updated Nov 9, 2021
In Brief
A Phase 2 clinical trial evaluating VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP, and 2 other interventions for HIV Infections. Completed, enrolled 326 participants across 3 sites in 3 countries.
Detailed Summary
The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya, Tanzania, Uganda
CollaboratorsUnited States Department of Defense
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2005
Enrollment StartMay 2006
Primary CompletionJun 2012
TodayJul 2026
First PostedJul 26, 2005
Enrollment StartMay 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.9 years ago
Interventions
VRC-HIVDNA016-00-VPbiological
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VPbiological
4 mg administered intramuscularly via injection
VRC-DILUENT013-DIL-VPbiological
Administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP placebobiological
4 mg administered intramuscularly via injection