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

Primary Purpose

HIV-1, HIV Infections

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

V520

Comparator: V520 (1x10^9 vp/d)

Comparator: V520 (1x10^10 vp/d)

Comparator: Placebo

About this trial

This is an interventional prevention trial for HIV-1 focused on measuring HIV Seronegativity, Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

V520 (1x10^9 vp/d)

V520 (1x10^10 vp/d)

Placebo to V520

Outcomes

Primary Outcome Measures

Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine

Secondary Outcome Measures

breadth of immune response measured by several assays

Full Information

NCT ID

NCT00849732

First Posted

February 20, 2009

Last Updated

February 26, 2015

Sponsor

Merck Sharp & Dohme LLC

Collaborators

HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00849732

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1, HIV Infections

Keywords

HIV Seronegativity, Preventive Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

V520 (1x10^9 vp/d)

Arm Title

Arm Type

Experimental

Arm Description

V520 (1x10^10 vp/d)

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo to V520

Intervention Type

Biological

Intervention Name(s)

V520

Intervention Description

Intentionally Blank

Intervention Type

Biological

Intervention Name(s)

Comparator: V520 (1x10^9 vp/d)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Comparator: V520 (1x10^10 vp/d)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Comparator: Placebo

Intervention Description

Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

Primary Outcome Measure Information:

Title

Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine

Time Frame

4 weeks after third vaccination

Secondary Outcome Measure Information:

Title

breadth of immune response measured by several assays

Time Frame

4 weeks after third vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

20854108

Citation

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 For The Merck V/Hiv Vaccine Trials Network Study Team SM. Safety and Immunogenicity of the MRKAd5 gag HIV Type 1 Vaccine in a Worldwide Phase 1 Study of Healthy Adults. AIDS Res Hum Retroviruses. 2011 May;27(5):557-567. doi: 10.1089/AID.2010.0151. Epub 2010 Nov 23.

Results Reference

result

PubMed Identifier

21533229

Citation

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.

Results Reference

derived

Learn more about this trial

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

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