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

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ClinicalTrials.gov Identifier: NCT00350623
Recruitment Status : Terminated
First Posted : July 11, 2006
Results First Posted : November 4, 2010
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks [ Time Frame: 30 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350623


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00350623     History of Changes
Other Study ID Numbers: V520-027
2006_501
First Posted: July 11, 2006    Key Record Dates
Results First Posted: November 4, 2010
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Merck Sharp & Dohme Corp.:
AIDS

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