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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00013572
Other study ID # B011
Secondary ID RV 138
Status Active, not recruiting
Phase Phase 1
First received March 21, 2001
Last updated June 23, 2005

Study information

Verified date March 2003
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
ALVAC-HIV MN120TMG (vCP205)


Locations

Country Name City State
United States Walter Reed Army Institute of Research (WRAIR) Rockville Maryland

Sponsors (1)

Lead Sponsor Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

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