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)

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894114
• Other study ID #: V520-019
• Secondary ID: 2009_585
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2009
• Last updated: May 27, 2015
• Start date: May 2003
• Est. completion date: June 2009

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Biological:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Yes
Secondary	immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays		4 weeks following vaccination	No