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

HIV Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850616
• Other study ID #: V526-001
• Secondary ID: 2009_551
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2009
• Last updated: October 30, 2015
• Start date: April 2005
• Est. completion date: March 2011

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: March 2011
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Biological:
• V526
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ, Quirk E; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs		Week 30	No
Primary	Immune response to MRKAd5+6 trigene vaccine		30 week	Yes
Secondary	Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6		Week 30	No