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)

Phase 1

Completed

• Conditions: HIV-1 Infection
• Interventions: Biological: V520

• Registration Number: NCT00894114
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stratum 3	V520	Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
Stratum 2	V520	Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
Stratum 4	V520	High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine

Primary Outcome Measures

Name	Time	Method
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

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