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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850616

Enrollment

147

Registered

2009-02-25

Start date

2005-04-30

Completion date

2011-03-31

Last updated

2015-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Infections

Keywords

HIV, HIV Seronegativity, Preventive Vaccine

Brief summary

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

Interventions

BIOLOGICALV526

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

BIOLOGICALComparator: Placebo to V526

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs	Week 30
Immune response to MRKAd5+6 trigene vaccine	30 week

Secondary

Measure	Time frame
Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6	Week 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026