Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

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 (V520)

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

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring AIDS

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

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

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00350623

First Posted

July 7, 2006

Last Updated

August 11, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00350623

Brief Title

Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

Official Title

A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Study Start Date

October 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

HIV Infections

Keywords

AIDS

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

V520

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

V520

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

V520

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

30 weeks

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: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial