Status:
COMPLETED
A Study of the Effectiveness of an HIV Vaccine (ALVAC vCP205) to Boost Immune Functions in HIV-Negative Volunteers Who Have Already Received an HIV Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this va...
Detailed Description
Vaccines may provide a route of therapy against HIV-1 infections by boosting the immune system responses. An artificially constructed HIV-1 vaccine (NYCBH), using vaccinia virus as its vector, has the...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are 18-60 years old.
- Are willing to use adequate birth control for 1 month before study entry and during the study.
- Have a CD4 count of at least 400 cells/mm3.
- Have a normal medical history and physical examination.
- Are available for 3 months of follow-up.
- Have participated in AVEG Protocol 014C or 022A and received all the scheduled vaccinations 24 or more months before this study, or have never participated in HIV-vaccine studies.
- Are HIV-negative within 8 weeks of study entry.
- Are negative for hepatitis B surface antigen.
Exclusion Criteria
You will not be eligible for this study if you:
- Are pregnant or breast-feeding.
- Have a history of an immune system problem, any long-term illness, or any autoimmune disease.
- Have a history of using medications which affect your immune system.
- Have a history of cancer, except if it has been removed with surgery and cure is most likely.
- Have a medical or mental condition which interferes with the study.
- Have a job or work which interferes with the study.
- Have ever attempted suicide, thought of attempting suicide, or have a severe mental condition.
- Have received vaccines within 60 days of study entry.
- Have used experimental drugs within 30 days prior to study entry.
- Have received any blood products, such as immunoglobulin, in the last 6 months.
- Have active syphilis.
- Have active tuberculosis.
- Have any history of severe allergic reactions, including reactions to vaccines.
- Have an allergy to egg products or neomycin.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2001
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00001136
End Date
May 1 2001
Last Update
November 1 2021
Active Locations (6)
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1
UAB AVEG
Birmingham, Alabama, United States, 35294
2
JHU AVEG
Baltimore, Maryland, United States, 21205
3
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63110
4
Univ. of Rochester AVEG
Rochester, New York, United States, 14642