At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 96 enrolled
Drug / intervention
Clade B gag DNA/PLG and env DNA/PLG Microparticles +1 morebiological
Likely dose
Not stated in 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 Clinical Trial to Evaluate the Safety and Immunogenicity of a Clade B Gag DNA/PLG and Env DNA/PLG Microparticles Vaccine and a Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant Vaccine in Healthy, HIV-1 Uninfected Adult Participants
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 19, 2003·Updated Oct 14, 2021
In Brief
A Phase 1 clinical trial evaluating Clade B gag DNA/PLG and env DNA/PLG Microparticles and Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant for HIV Infections. Completed, enrolled 96 participants across 4 sites.
Detailed Summary
To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2003
Study CompletionSep 2007
TodayJul 2026
First PostedNov 19, 2003
Study CompletionSep 1, 2007
TodayJul 2, 2026
Posted 22.6 years ago
Interventions
Clade B gag DNA/PLG and env DNA/PLG Microparticlesbiological
Clade B Recombinant, Oligomeric gp140/MF59 Adjuvantbiological