HIV-1 Infection
Conditions
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.
Interventions
BIOLOGICALV520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
BIOLOGICALComparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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 |
Outcome results
None listed