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)

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V520

Biological

MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection

Comparator: ALVAC-HIV vaccine

Biological

A single dose 0.1 intramuscular injection

Primary outcomes

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.

Time frame: 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 outcomes

immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays

Time frame: 4 weeks following vaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2009
Study completion: 2009
First posted: May 6, 2009
Registry last updated: May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed