Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00350623
First received: July 7, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.


Condition Intervention Phase
HIV Infections
Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
Phase 2

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 Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Other Name: V520
Experimental: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Other Name: V520
Experimental: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Other Name: V520

  Eligibility

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

Inclusion Criteria:

  • Demonstrates good general health
  • Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
  • Low risk of acquiring HIV infection
  • ALT lab value within normal range

Exclusion Criteria:

  • Previously received an investigational HIV vaccine
  • Has a known or suspected impairment of immunologic function
  • Has a clinically significant chronic medical condition that is considered progressive
  • Has a major psychiatric illness
  • Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
  • Weighs less than 105 lbs.
  • Has a recent (within two years) history of chronic alcohol abuse
  • Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
  • Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
  • Male subject is planning to impregnate or provide sperm donation during the study
  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: NCT00350623

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

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00350623     History of Changes
Other Study ID Numbers: V520-027, 2006_501
Study First Received: July 7, 2006
Results First Received: October 20, 2010
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
AIDS

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

ClinicalTrials.gov processed this record on October 22, 2014