CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 317 enrolled
Drug / intervention
Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) +8 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/NCT00849680
NCT00849680Phase 1Completed
CompareCT.gov

A Phase I Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRKAd5 HIV-1 Gag/Pol/Nef) in a Prime-Boost Regimen in Healthy Adults

Merck Sharp & Dohme LLC·interventional·Posted Feb 24, 2009·Updated Feb 2, 2015

In Brief

A Phase 1 clinical trial evaluating Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine, Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose), and 7 other interventions for HIV-1 and HIV Infections. Completed, enrolled 317 participants.

Detailed Summary

The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1, HIV Infections
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2009
Enrollment StartApr 1, 2003
Primary CompletionMar 1, 2005
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.4 years ago

Interventions

Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccineother

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)biological

Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose)

Comparator: Placebo to MRKAd5 HIV-1 gag vaccinebiological

Placebo to the MRKAd5 HIV-1 gag vaccine.