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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001136 |
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.
Condition | Intervention | Phase |
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HIV Infections HIV Seronegativity |
Biological: ALVAC-HIV MN120TMG (vCP205) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Safety Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | March 2000 |
Primary Completion Date: | May 2001 (Final data collection date for primary outcome measure) |
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 advantage of conferring both cellular and humoral immune responses that are long-lived. Studies have shown that a second artificially constructed vector vaccine, HIV-1 canarypox (vCP205), also increases CD8+ cytotoxic T lymphocyte (CTL) activity, a cell-mediated immune response. Yet, immune responses are not boosted in volunteers previously vaccinated with vaccinia-based HIV-1 vaccines when a second vaccination with the same vaccine is given. One theory for vaccinia vaccine's failure is that immunologic barriers by antibodies to the vector itself may be responsible. This study examines the effectiveness of boosting the immune responses following vCP205 vaccination in the following: 1) volunteers who were previously immunized with vCP205 vaccine who may or may not have shown increased immune responses following the first immunization, and 2) volunteers who were previously immunized with NYCBH vaccine.
Upon study entry volunteers receive one injection of ALVAC-HIV vCP205. Temperature and symptoms should be recorded by the volunteer each day for 2 days and reported to the clinic staff. Volunteers will have seven clinic visits for drawing blood, collecting urine specimens, and performing clinical evaluations. At Month 3 HIV testing will be done. Volunteers will be followed for 3 months, with a passive follow-up call at the end of a year and once or twice a year for the next 5 years. Counseling on avoidance of HIV infection and pregnancy will be done.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health | |
Baltimore, Maryland, United States, 21205 | |
United States, Missouri | |
Saint Louis Univ Health Sciences Ctr | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington / Fred Hutchinson Cancer Research | |
Seattle, Washington, United States, 98104 |
Study Chair: | Thomas Evans |
Study ID Numbers: | AVEG 038 |
Study First Received: | January 25, 2000 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00001136 |
Health Authority: | United States: Federal Government |
Injections, Intramuscular HIV-1 AIDS Vaccines CD4-Positive T-Lymphocytes CD8-Positive T-Lymphocytes T-Lymphocytes, Cytotoxic Gene Products, gag |
HIV Seronegativity Immunologic Memory Antibodies, Viral Genetic Vectors Gene Products, env Poxviridae HIV Preventive Vaccine |
Virus Diseases Antibodies Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Immunoglobulins |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |