At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 480 enrolled
Drug / intervention
VRC-HIVDNA016-00-VP +3 morebiological
Likely dose
VRC-HIVDNA016-00-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.
HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 2, 2005·Updated Oct 15, 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 480 participants across 12 sites in 5 countries.
Detailed Summary
The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Haiti, Jamaica, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartSep 2005
Primary CompletionFeb 2008
Study CompletionJan 2010
TodayJul 2026
First PostedAug 2, 2005
Enrollment StartSep 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.9 years ago
Interventions
VRC-HIVDNA016-00-VPbiological
4 mg administered in deltoid
VRC-HIVADV014-00-VPbiological
1 x 10\^10 PU administered in deltoid
VRC-HIVDNA016-00-VP placebobiological
1 mL administered at study entry and Months 1 and 2
VRC-HIVADV014-00-VP placebobiological
1 mL administered at Month 6