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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849732
• Other study ID #: V520-018
• Secondary ID: 2009_549
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2009
• Last updated: February 26, 2015
• Start date: June 2003
• Est. completion date: February 2011

Study information

• Verified date: February 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2011
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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
• HIV-1

Intervention

Biological:
• V520
Intentionally Blank
• 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
• 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
• Comparator: Placebo
Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

References & Publications (1)

Nicholson O, Dicandilo F, Kublin J, Sun X, Quirk E, Miller M, Gray G, Pape J, Robertson MN, Mehrotra DV, Self S, Turner K, Sanchez J, Pitisuttithum P, Duerr A, Dubey S, Kierstead L, Casimiro D, Hammer SM; for the Merck V520-018/HIV Vaccine Trials Network — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine		4 weeks after third vaccination	Yes
Secondary	breadth of immune response measured by several assays		4 weeks after third vaccination	No