At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 17 enrolled

Drug / intervention

MRKAd5 HIV-1 gag vaccine (V520) +3 morebiological

Likely dose

Comparator: Placebo 1.0 mLfrom 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/NCT00857311

NCT00857311Phase 1Completed

Compare CT.gov

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection

Merck Sharp & Dohme LLC·interventional·Posted Mar 6, 2009·Updated Aug 25, 2015

In Brief

A Phase 1 clinical trial evaluating MRKAd5 HIV-1 gag vaccine (V520), Comparator: Placebo, and 1 other intervention for Hepatitis C. Completed, enrolled 17 participants.

Detailed Summary

A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

Countries--

Collaborators--

Timeline

Phase 1CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2004

Primary CompletionJan 2006

First PostedMar 2009

Study CompletionMay 2010

TodayJul 2026

First PostedMar 6, 2009

Enrollment StartMay 1, 2004

Primary CompletionJan 1, 2006

Study CompletionMay 1, 2010

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 17.3 years ago

Interventions

MRKAd5 HIV-1 gag vaccine (V520)biological

3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26

Comparator: Placebobiological

1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26

Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbedbiological

0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only

MRKAd5 HIV-1 gag vaccine (V520)biological

3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26