NCT00849732

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

February 20, 2009

Last Update Submit

February 26, 2015

Conditions

HIV-1HIV Infections

Keywords

HIV SeronegativityPreventive Vaccine

Outcome Measures

Primary Outcomes (1)

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

    4 weeks after third vaccination

Secondary Outcomes (1)

  • breadth of immune response measured by several assays

    4 weeks after third vaccination

Study Arms (3)

1

EXPERIMENTAL

V520 (1x10\^9 vp/d)

Biological: V520Biological: Comparator: V520 (1x10^9 vp/d)

2

EXPERIMENTAL

V520 (1x10\^10 vp/d)

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

3

PLACEBO COMPARATOR

Placebo to V520

Biological: Comparator: Placebo

Interventions

V520BIOLOGICAL

Intentionally Blank

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

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

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

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

2
Comparator: PlaceboBIOLOGICAL

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

3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20854108RESULT

  • 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.

    PMID: 21533229DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 24, 2009

Study Start

June 1, 2003

Primary Completion

October 1, 2006

Study Completion

February 1, 2011

Last Updated

February 27, 2015

Record last verified: 2015-02