A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)

This study has been completed.
Sponsor:
Collaborators:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00849732
First received: February 20, 2009
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10^9 vp/d, at 1x10^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.


Condition Intervention Phase
HIV-1
HIV Infections
Biological: V520
Biological: Comparator: V520 (1x10^9 vp/d)
Biological: Comparator: V520 (1x10^10 vp/d)
Biological: Comparator: Placebo
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 Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • breadth of immune response measured by several assays [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: June 2003
Study Completion Date: February 2011
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
V520 (1x10^9 vp/d)
Biological: V520
Intentionally Blank
Biological: Comparator: V520 (1x10^9 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^9 vp/d given at Day 1, Week 4, and Week 26
Experimental: 2
V520 (1x10^10 vp/d)
Biological: Comparator: V520 (1x10^10 vp/d)
1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10^10 vp/d given at Day 1, Week 4, and Week 26
Placebo Comparator: 3
Placebo to V520
Biological: Comparator: Placebo
Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good general health
  • Subject tests negative for Hepatitis B, Hepatitis C, and HIV
  • Subjects of reproductive potential agree to use an accepted method of birth control through the entire study

Exclusion Criteria:

  • Subject has a recent history of fever at time of vaccination
  • Subject has received immune globulin or blood product 3 months prior to injection
  • Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
  • Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
  • Subject has a chronic medical condition that is considered progressive
  • Subject has history of malignancy
  • Subject weighs less than 105 lb.
  • Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
  • Subject has contraindication to intramuscular injection
  • Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
  • Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
  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: NCT00849732

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00849732     History of Changes
Other Study ID Numbers: V520-018, 2009_549
Study First Received: February 20, 2009
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HIV Seronegativity
Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014