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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: | NCT00043511 |
The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is well tolerated at two different doses. Another important purpose of this study is to observe how the immune system responds to the vaccine at different dose levels.
Vaccines are given to people to help their bodies fight infection. The vaccine being tested in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV from the vaccination. This and other similar DNA vaccines have been tested for safety in mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this study.
Condition | Intervention | Phase |
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HIV Infections |
Biological: pGA2/JS2 Plasmid DNA Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Placebo Control, Safety Study |
Official Title: | A Phase I Trial to Evaluate the Safety and Immunogenicity of the HIV-1 pGA2/JS2 Plasmid DNA Vaccine Given Intramuscularly (IM) in HIV-1 Uninfected Adults |
Estimated Enrollment: | 30 |
DNA vaccination has induced immune responses in animals to a number of viral, bacterial, and parasite derived antigens. Early clinical experiences with HIV DNA vaccines in humans indicate: 1) the tolerability and short-term safety of DNA at doses up to 5000 mcg in humans are excellent; and 2) there is potential for immunogenicity.
The pGA2/JS2 DNA vaccine is part of a planned prime/boost regimen of a DNA vaccine prime followed by a modified vaccinia Ankara (MVA) vaccine boost. In studies in monkeys, a combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused by a monkey virus similar to HIV. The current study is an initial investigation of the safety and immunogenicity of the DNA vaccine given alone. The pGA2/JS2 DNA vaccine expresses gag, protease, reverse transcriptase, env, tat, vpu, and rev.
Participants are randomized to 1 of 2 groups. People in Group A receive either 2 injections of a lower dose (300 mcg) of the DNA plasmid vaccine or the placebo control. People in Group B receive either 2 injections of a higher dose (3000 mcg) of the DNA plasmid vaccine or the control. Group B will be enrolled only if the vaccine is found to be safe and well-tolerated during the initial 2-week evaluation of all participants in Group A. Participants receive vaccinations administered at Months 0 and 2. All vaccinations are administered by intramuscular (IM) injection in an outpatient setting. Participants have about 10 clinic visits during this study, including the screening and injection visits. Participants give blood and urine samples at study visits. They are tested for HIV before entering the study and 4 more times during the study. Women who can become pregnant may undergo up to 3 pregnancy tests during the study period.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Participants may be eligible for this study if they:
Exclusion Criteria
Participants may not be eligible for this study if they:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States | |
United States, California | |
San Francisco Department of Health | |
San Francisco, California, United States | |
Mt. Zion Hosp-GCRC | |
San Francisco, California, United States, 94102 | |
United States, Washington | |
FHCRC/University of Washington | |
Seattle, Washington, United States |
Study Chair: | Mark Mulligan | University of Alabama at Birmingham |
Study ID Numbers: | HVTN 045 |
Study First Received: | August 9, 2002 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00043511 |
Health Authority: | United States: Food and Drug Administration |
Injections, Intramuscular HIV Seronegativity Plasmids Vaccines, DNA HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |