CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 105 enrolled
Drug / intervention
DNA Nat-B env +7 morebiological
Likely dose
DNA Nat-B env 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.

Search/NCT02296541
NCT02296541Phase 1Completed
CompareCT.gov

A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of 3 Different HIV-1 DNA Priming Regimens (Nat-B Env, CON-S Env, and Mosaic Env) With MVA-CMDR Boosts in Healthy, HIV-1-Uninfected Adults

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 20, 2014·Updated Apr 24, 2023

In Brief

A Phase 1 clinical trial evaluating DNA Nat-B env, DNA CON-S env, and 6 other interventions for HIV Infections. Completed, enrolled 105 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSwitzerland, United States
CollaboratorsCHAVI, IPPOX Foundation, MHRP, HIV Vaccine Trials Network

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 20, 2014
Enrollment StartDec 1, 2014
Primary CompletionNov 1, 2016
Study CompletionJul 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago

Interventions

DNA Nat-B envbiological

4 mg to be administered as 1 mL intramuscularly (IM) by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

DNA CON-S envbiological

4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

DNA Mosaic envbiological

4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

MVA-CMDRbiological

1×10\^8 plaque forming units (pfu) to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Placebo for DNA Nat-B envbiological

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Placebo for DNA CON-S envbiological

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Placebo for DNA Mosaic envbiological

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)

Placebo for MVA-CMDRbiological

Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)