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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	360 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	June 2003
Actual Primary Completion Date :	October 2006
Actual Study Completion Date :	February 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine [ Time Frame: 4 weeks after third vaccination ]

Secondary Outcome Measures :

1. breadth of immune response measured by several assays [ Time Frame: 4 weeks after third vaccination ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

HIV Vaccine Trials Network

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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 050 Study Team. Safety and Immunogenicity of the MRKAd5 gag HIV Type 1 Vaccine in a Worldwide Phase 1 Study of Healthy Adults. AIDS Res Hum Retroviruses. 2010 Nov 23. [Epub ahead of print]

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pine SO, Kublin JG, Hammer SM, Borgerding J, Huang Y, Casimiro DR, McElrath MJ. Pre-existing adenovirus immunity modifies a complex mixed Th1 and Th2 cytokine response to an Ad5/HIV-1 vaccine candidate in humans. PLoS One. 2011 Apr 13;6(4):e18526. doi: 10.1371/journal.pone.0018526.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00849732 History of Changes
Other Study ID Numbers:	V520-018; 2009_549
First Posted:	February 24, 2009
Last Update Posted:	February 27, 2015
Last Verified:	February 2015

Keywords provided by Merck Sharp & Dohme Corp.:

HIV Seronegativity; Preventive Vaccine

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; Vaccines; Immunologic Factors; Physiological Effects of Drugs