Clinical trial NCT00894114: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays
timeFrame: 4 weeks following vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: