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HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

Primary Purpose

HIV Infections, HIV Seronegativity

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALVAC-HIV MN120TMG (vCP205)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Injections, Intramuscular, Injections, Intradermal, Injections, Subcutaneous, HIV-1, AIDS Vaccines, Dendritic Cells, HIV Seronegativity, Genes, env, Genes, pol, Genes, gag, Transfection, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Volunteers may be eligible for this study if they: Are legal US residents. Are healthy adults from 18 to 55 years of age. Exclusion Criteria Volunteers will not be eligible for this study if they: Are HIV-positive. Are at highest risk for HIV infection. Are pregnant or breast-feeding. Are allergic to eggs or neomycin. Use certain prescription medications.

Sites / Locations

Walter Reed Army Institute of Research (WRAIR)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00013572

First Posted

March 21, 2001

Last Updated

June 23, 2005

Sponsor

Walter Reed Army Institute of Research (WRAIR)

1. Study Identification

Unique Protocol Identification Number

NCT00013572

Brief Title

HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

Official Title

A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly

Study Type

Interventional

2. Study Status

Record Verification Date

March 2003

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Walter Reed Army Institute of Research (WRAIR)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Detailed Description

Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

6. Conditions and Keywords

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

HIV Infections, HIV Seronegativity

Keywords

Injections, Intramuscular, Injections, Intradermal, Injections, Subcutaneous, HIV-1, AIDS Vaccines, Dendritic Cells, HIV Seronegativity, Genes, env, Genes, pol, Genes, gag, Transfection, HIV Preventive Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Enrollment

36 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

ALVAC-HIV MN120TMG (vCP205)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Marovich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Institute of Research (WRAIR)

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21949699

Citation

Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.

Results Reference

derived

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HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

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