NCT00350623

Brief Summary

This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2 hiv-infections

Status
terminated

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

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 4, 2010

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

July 7, 2006

Results QC Date

October 20, 2010

Last Update Submit

August 11, 2015

Conditions

HIV Infections

Keywords

AIDS

Outcome Measures

Primary Outcomes (1)

  • Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks

    30 weeks

Study Arms (3)

MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose

EXPERIMENTAL

MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)

MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose

EXPERIMENTAL

MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)

MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose

EXPERIMENTAL

MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)

Interventions

MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Also known as: V520
MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Also known as: V520
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)BIOLOGICAL

3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Also known as: V520
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose

Eligibility Criteria

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

You may qualify if:

  • Demonstrates good general health
  • Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
  • Low risk of acquiring HIV infection
  • ALT lab value within normal range

You may not qualify if:

  • Previously received an investigational HIV vaccine
  • Has a known or suspected impairment of immunologic function
  • Has a clinically significant chronic medical condition that is considered progressive
  • Has a major psychiatric illness
  • Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
  • Weighs less than 105 lbs.
  • Has a recent (within two years) history of chronic alcohol abuse
  • Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
  • Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
  • Male subject is planning to impregnate or provide sperm donation during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

An interim analysis of a related study, V520-023 (NCT00095576), showed that the vaccine used in V520-027 (NCT00350623) was not efficacious; therefore, vaccinations in V520-027 were stopped and only a high level summary of safety data was performed.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 25, 2015

Results First Posted

November 4, 2010

Record last verified: 2015-08