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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00350623
• Other study ID #: V520-027
• Secondary ID: 2006_501
• Status: Terminated
• Phase: Phase 2
• First received: July 7, 2006
• Last updated: August 11, 2015
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: August 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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 Infections

Intervention

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.
• 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.
• 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.

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	Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks		30 weeks	No