CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
env (A,B,C,A/E)/gag (C) DNA Vaccine +3 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.

Search/NCT03409276
NCT03409276Phase 1Completed
CompareCT.gov

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A,B,C,A/E) / Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV-1 Vaccines (PDPHV-201401) as a Prime-boost Regimen or Co-administered in Repeated Doses, in Healthy, HIV-1-Uninfected Adult Participants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 24, 2018·Updated Apr 25, 2022

In Brief

A Phase 1 clinical trial evaluating env (A,B,C,A/E)/gag (C) DNA Vaccine, gp120 (A,B,C,A/E) Protein Vaccine, and 2 other interventions for HIV Infections. Completed, enrolled 60 participants across 6 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 24, 2018
Enrollment StartMar 16, 2018
Primary CompletionMay 11, 2020
Study CompletionOct 22, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.4 years ago

Interventions

env (A,B,C,A/E)/gag (C) DNA Vaccinebiological

Administered by intramuscular injection in the deltoid.

gp120 (A,B,C,A/E) Protein Vaccinebiological

Administered by intramuscular injection in the deltoid.

Placebobiological

Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.

GLA-SE adjuvantbiological

Administered by intramuscular injection in the deltoid.