- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00013572
HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
June 23, 2005 updated by: Walter Reed Army Institute of Research (WRAIR)
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
The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Walter Reed Army Institute of Research (WRAIR)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mary Marovich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 21, 2001
First Submitted That Met QC Criteria
August 30, 2001
First Posted (ESTIMATE)
August 31, 2001
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 2003
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B011
- RV 138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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