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A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

NCT ID: NCT00849680

Last Updated: 2015-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-02-28

Brief Summary

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The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef

Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.

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Detailed Description

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The study will proceed in four stages. Following stages I, II and III, all subjects will have the Postdose 1 (PD1) clinical and laboratory safety data reviewed by the Safety Evaluation Committee (SEC). If these data are acceptable, the next stage will be initiated.

* In Stage I, participants will be randomized to receive 3 doses of the 3x10\^9vp/dose level Trivalent vaccine or placebo.
* In Stage II, participants will be randomized to receive 2 or 3 doses of the 3x10\^10vp/dose level Trivalent vaccine or placebo.
* In Stage III, participants will be randomized to receive 3 doses of the Trivalent vaccine with titers of 1x10\^11vp/dose, 3x10\^6vp/dose, 3x10\^7vp/dose, or 3x10\^8vp/dose or placebo.
* In Stage IV, participants will be randomized to all treatment groups. In addition, some participants will be randomized to an MRKAd 5 HIV-1 gag Monovalent vaccine. In this stage, participants will be pre-stratified by baseline Ad5 titers (=\<200, and \>200), to ensure an even distribution of participants with high and low Ad5 titers across the various treatment groups.

Conditions

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HIV-1 HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants receiving 1.0 ml of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or the placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26 or a 2-dose regimen at Day 1 and Week 26 or Day 1 and Week 4.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine

Intervention Type OTHER

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

Intervention Type BIOLOGICAL

Placebo to the MRKAd5 HIV-1 gag vaccine.

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Participants receiving 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Intervention Type BIOLOGICAL

Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26, or in a 2-dose regimen at Day 1 and Week 4 (with no vaccine administered at Week 26) or Day 1 and Week 26 (with placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine administered at Week 4)

Group Type EXPERIMENTAL

Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine

Intervention Type OTHER

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.

Group Type EXPERIMENTAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose)

Interventions

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Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

Intervention Type OTHER

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose)

Intervention Type BIOLOGICAL

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose)

Intervention Type BIOLOGICAL

Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

Placebo to the MRKAd5 HIV-1 gag vaccine.

Intervention Type BIOLOGICAL

Other Intervention Names

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V520 V520 V520 V520 V520 V520 V520

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 Years to 45 Years in Stages I-III and 18 Years to 50 Years in Stage IV.
* Subject is in good general health
* Subjects of reproductive potential agree to use acceptable method of birth control through study
* Subject tests negative for Hepatitis B, Hepatitis C, and HIV

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 has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
* Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.

Reference Type BACKGROUND
PMID: 18433307 (View on PubMed)

Li F, Finnefrock AC, Dubey SA, Korber BT, Szinger J, Cole S, McElrath MJ, Shiver JW, Casimiro DR, Corey L, Self SG. Mapping HIV-1 vaccine induced T-cell responses: bias towards less-conserved regions and potential impact on vaccine efficacy in the Step study. PLoS One. 2011;6(6):e20479. doi: 10.1371/journal.pone.0020479. Epub 2011 Jun 10.

Reference Type DERIVED
PMID: 21695251 (View on PubMed)

Hutnick NA, Carnathan DG, Dubey SA, Cox KS, Kierstead L, Makadonas G, Ratcliffe SJ, Lasaro MO, Robertson MN, Casimiro DR, Ertl HC, Betts MR. Vaccination with Ad5 vectors expands Ad5-specific CD8 T cells without altering memory phenotype or functionality. PLoS One. 2010 Dec 22;5(12):e14385. doi: 10.1371/journal.pone.0014385.

Reference Type DERIVED
PMID: 21203546 (View on PubMed)

Other Identifiers

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2009_548

Identifier Type: -

Identifier Source: secondary_id

V520-016

Identifier Type: -

Identifier Source: org_study_id

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