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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: | NCT00054860 |
The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.
Condition | Intervention | Phase |
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HIV Infections |
Biological: EP HIV-1090 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of the EP HIV-1090 DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants |
Estimated Enrollment: | 42 |
Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T lymphocyte (CTL) responses contribute to control and clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for protection against HIV infection and disease progression. EP HIV-1090 is a DNA vaccine composed of 21 highly specific CTL epitopes. The vaccine is designed to optimize the immune response in people expressing one of three HLA Class I antigen subtypes: HLA-A2, -A3, and -B7. This design is predicted to induce an immune response in 85% of individuals in the general population. There is also a helper T lymphocyte (HTL) facilitating epitope (PADRE) in the vaccine. The vaccine is formulated with a water soluble polymer (polyvinylpyrrolidone) that protects the DNA and facilitates cellular uptake. This study will assess the safety of and immune response to different doses of EP HIV-1090 in healthy, HIV uninfected adults.
Participants in this study will be randomized to receive either one of three different doses of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular injection. Participants will be followed for 18 months and will have 12 study visits. Each study visit will include a physical exam, medical history, and blood and urine tests. Each participant will have four HIV tests during the study. Women will have at least five pregnancy tests during the study.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
United States, Massachusetts | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 | |
Harvard Med School/Brigham & Womens Hosp | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
St. Louis Univ - New Hope Bldg. | |
St. Louis, Missouri, United States, 63110-2500 | |
United States, Rhode Island | |
Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
Botswana | |
Botswana HIV Vaccine Clinical Eval. Ctr | |
Gaborone, Botswana |
Study Chair: | Geoffrey J. Gorse, MD | St. Louis University |
Study ID Numbers: | HVTN 048 |
Study First Received: | February 11, 2003 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00054860 |
Health Authority: | United States: Food and Drug Administration |
HIV Preventive Vaccine HIV Seronegativity HIV-1 AIDS Vaccines Vaccines, DNA |
Dose-Response Relationship, Immunologic CD4-Positive T-Lymphocytes CD8-Positive T-Lymphocytes Epitopes |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |