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)
NCT ID: NCT00894114
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
250 participants
INTERVENTIONAL
2003-05-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Stratum 1
Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine
Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Stratum 2
Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
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
V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
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
V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Interventions
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V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2009_585
Identifier Type: -
Identifier Source: secondary_id
V520-019
Identifier Type: -
Identifier Source: org_study_id
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