A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)(COMPLETED)

This study has been completed.

Sponsor:

Collaborators:

HIV Vaccine Trials Network

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00849732

First received: February 20, 2009

Last updated: March 25, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 20, 2009

Last Updated Date

March 25, 2011

Start Date ^ICMJE

June 2003

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00849732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

breadth of immune response measured by several assays [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)(COMPLETED)

Official Title ^ICMJE

A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults

Brief Summary

This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

HIV-1
HIV Infections

Intervention ^ICMJE

Biological: V520
Intentionally Blank
Biological: Comparator: V520 (1x10^9 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26
Biological: Comparator: V520 (1x10^10 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26
Biological: Comparator: Placebo
Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

Study Arm (s)

Experimental: 1
V520 (1x10^9 vp/d)
Interventions:
- Biological: V520
- Biological: Comparator: V520 (1x10^9 vp/d)
Experimental: 2
V520 (1x10^10 vp/d)

Intervention: Biological: Comparator: V520 (1x10^10 vp/d)
Placebo Comparator: 3
Placebo to V520

Intervention: Biological: Comparator: Placebo

Publications *

Pine SO, Kublin JG, Hammer SM, Borgerding J, Huang Y, Casimiro DR, McElrath MJ. Pre-existing adenovirus immunity modifies a complex mixed Th1 and Th2 cytokine response to an Ad5/HIV-1 vaccine candidate in humans. PLoS One. 2011 Apr 13;6(4):e18526.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

360

Completion Date

February 2011

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject is in good general health
Subject tests negative for Hepatitis B, Hepatitis C, and HIV
Subjects of reproductive potential agree to use an accepted method of birth control through the entire study

Exclusion Criteria:

Subject has a recent history of fever at time of vaccination
Subject has received immune globulin or blood product 3 months prior to injection
Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
Subject has a chronic medical condition that is considered progressive
Subject has history of malignancy
Subject weighs less than 105 lb.
Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
Subject has contraindication to intramuscular injection
Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00849732

Other Study ID Numbers ^ICMJE

2009_549, V520-018

Has Data Monitoring Committee

Responsible Party

Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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