HIV Infections Clinical Trial
Official title:
A Multi-Centered Phase 1 Trial to Evaluate the Memory Responses to a Single Boosting Vaccination With ALVAC-HIV vCP205 in Volunteers Who Have Previously Received Poxvirus-Based Vaccines
NCT number | NCT00001136 |
Other study ID # | AVEG 038 |
Secondary ID | 10586 |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Est. completion date | May 2001 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2001 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | JHU AVEG | Baltimore | Maryland |
United States | UAB AVEG | Birmingham | Alabama |
United States | Vanderbilt Univ. Hosp. AVEG | Nashville | Tennessee |
United States | Univ. of Rochester AVEG | Rochester | New York |
United States | St. Louis Univ. School of Medicine AVEG | Saint Louis | Missouri |
United States | UW - Seattle AVEG | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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