A Study of Safety, Tolerability and Immunogenicity of a 1-Dose Regimen of MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC_HIV Vaccine (V520-019)

A Probe Study of the Safety, Tolerability, and Immunogenicity of a 1-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC-HIV (vCP205) Vaccine in Healthy Adults Who Previously Received a 3-Dose Regimen of MRKAd5, Ad5, or Placebo in Merck V520 Protocols 007 or 012

This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Biological: Comparator: ALVAC-HIV vaccine; Biological: V520

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
• Subject is in good general health
• Subject is not infected with HIV
• Subject agrees not to donate blood during the first 52 weeks of the study
• Subject agrees not to donate sperm during the first 12 weeks of the study
• Subject who is of reproductive potential agrees to use an acceptable method of birth control through Week 12 of the study

Exclusion Criteria:

• Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
• Subject has been vaccinated with a live virus vaccine in the past 30 days
• Subject has been vaccinated with an inactivated vaccine in the past 14 days
• Subject has an active medical disease
• Subject is taking daily required prescription drugs
• Female subject is pregnant, breastfeeding or expecting to conceive
• Subject is positive for HIV
• Subject has used injection drug within the past year
• Subject has a sexual partner that is infected with HIV
• Subject has a sexual partner that is an active injection drug user
• Subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months
• Subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months
• Subject engaged in protected intercourse with more than 4 persons in the previous 6 months
• Subject has previously participated in an HIV vaccine clinical trial (other than Merck V520 Protocols 007 and 012)
• Subject weighs less than 110 lbs.
• Subject has a recent history of alcohol abuse
• Subject intends to donate blood in the first 52 weeks of the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Stratum 1; Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine	Biological: Comparator: ALVAC-HIV vaccine; A single dose 0.1 intramuscular injection
EXPERIMENTAL: Stratum 2; Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine	Biological: Comparator: ALVAC-HIV vaccine; A single dose 0.1 intramuscular injection; Biological: V520; MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
EXPERIMENTAL: Stratum 3; Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine	Biological: Comparator: ALVAC-HIV vaccine; A single dose 0.1 intramuscular injection; Biological: V520; MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
EXPERIMENTAL: Stratum 4; High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine	Biological: Comparator: ALVAC-HIV vaccine; A single dose 0.1 intramuscular injection; Biological: V520; MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.	Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).

Secondary Outcome Measures

Outcome Measure	Time Frame
immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays	4 weeks following vaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (ESTIMATE): May 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: V520-019; 2009_585