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OpenTrials
Completed

NCT Number: NCT00850616

Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)

A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
  • Subject agrees to use an acceptable method of birth control through week 52 of the study

Exclusion criteria

  • Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
  • Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
  • Subject has known or suspected impaired immune function
  • Subject has participated in any other HIV vaccine trial
  • Female subject is pregnant or breastfeeding

Treatment and study plan

V526

Biological

0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.

Comparator: Placebo to V526

Biological

0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.

Primary outcomes

  1. Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs

    Time frame: Week 30

  2. Immune response to MRKAd5+6 trigene vaccine

    Time frame: 30 week

Secondary outcomes

  1. Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6

    Time frame: Week 30

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I Dose Ranging Study of the Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults

Important dates

Study start
2005
Primary completion
2006
Study completion
2011
First posted
Feb 25, 2009
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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