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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00894114
First received: May 4, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Biological: V520
Biological: Comparator: ALVAC-HIV vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: May 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stratum 1
Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine
Biological: Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Experimental: Stratum 2
Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
Biological: V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Biological: Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Experimental: 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
Biological: V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Biological: Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection
Experimental: 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
Biological: V520
MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection
Biological: Comparator: ALVAC-HIV vaccine
A single dose 0.1 intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894114

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00894114     History of Changes
Other Study ID Numbers: V520-019, 2009_585
Study First Received: May 4, 2009
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014