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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) HIV Vaccine Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00301184 |
The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.
Condition | Intervention | Phase |
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HIV Infections |
Biological: pGA2/JS7 DNA Biological: Modified vaccinia Ankara/HIV62 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA Vaccine and Recombinant Modified Vaccinia Ankara/HIV62 Vaccine in Healthy, HIV-1-Uninfected Adult Participants |
Estimated Enrollment: | 120 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1A: Experimental
One 0.3 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10^7 TCID50 MVA or placebo at Months 4 and 6
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Biological: pGA2/JS7 DNA
DNA Vaccine
Biological: Modified vaccinia Ankara/HIV62
Recombinant Modified Ankara Vaccine
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1B: Experimental
One 3.0 mg dose of DNA HIV vaccine or placebo administered at study entry and Month 2, followed by one dose of 1x10^8 TCID50MVA or placebo administered at Months 4 and 6
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Biological: pGA2/JS7 DNA
DNA Vaccine
Biological: Modified vaccinia Ankara/HIV62
Recombinant Modified Ankara Vaccine
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2A: Experimental
One MTD (determined in Part 1) of DNA HIV vaccine or placebo administered at study entry. One dose of placebo or MTD of MVA at Months 2 and 6
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Biological: pGA2/JS7 DNA
DNA Vaccine
Biological: Modified vaccinia Ankara/HIV62
Recombinant Modified Ankara Vaccine
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2B: Experimental
One dose of placebo or MTD of MVA administered at study entry and Months 2 and 6
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Biological: Modified vaccinia Ankara/HIV62
Recombinant Modified Ankara Vaccine
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The worldwide HIV/AIDS epidemic may only be controlled through a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, easily produced in large quantities, and stable for long periods of time. Recombinant modified vaccinia Ankara vaccines have been shown to be safe in humans, and immunogenicity after administration of both vaccines has been encouraging. When used together, a more robust immunologic response was associated with DNA HIV vaccine administration followed by modified vaccinia vaccine administration, compared to using either DNA or vaccinia vaccine alone. This study will evaluate the safety and immunogenicity of an experimental DNA HIV vaccine prime, pGA/JS7, followed by a similarly structured modified vaccinia boost, MVA/HIV62, in HIV uninfected adults. Participants in this study will be recruited only in the United States.
This study will be divided into 2 parts. Each participant will be involved with their part of study for 1 year. Participants in Part 1 will be randomly assigned to one of two different vaccination groups. Group 1A participants will be randomly assigned to receive either placebo or 2 lower doses of the DNA HIV vaccine (DNA) at study entry and Month 2, followed by 2 lower doses of the modified vaccinia vaccine (MVA) at Months 4 and 6. Group 1B will not enroll until safety and immunogenicity data from Group 1A have been evaluated. Group 1B participants will receive either placebo or two higher doses of DNA at study entry and Month 2, followed by two higher doses of MVA at Months 4 and 6.
Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed. In Part 2, participants will be randomly assigned to one of two different vaccination groups. Within each group, participants will be randomly assigned to receive some series of vaccines or placebo. Group 2A participants will receive either placebo or the maximum tolerated dose (MTD) from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6. Group 2B participants will receive MTD of MVA at study entry and Months 2 and 6.
There will be 12 study visits over 12 months for Groups 1 and 2. There will be 11 study visits over 12 months for Groups 3 and 4. Medication history, a physical exam, an interview, HIV and pregnancy prevention counseling, and adverse events reporting will occur at all visits. Blood and urine collection and an electrocardiogram (ECG) will occur at selected visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
More information on this criterion can be found in the protocol.
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294-2041 | |
Contact: Susan Duncan, RN, MSN 205-975-2840 sduncan@uab.edu | |
United States, Maryland | |
University of Maryland - Institute of Human Virology | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Cynthia Starr Hendel, MSN, CRNP, CCRC (410) 706-1289 hendel@umbi.umd.edu | |
United States, Massachusetts | |
Harvard Medical School/ Brigham & Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Lizanne C. Noble, MPH 617-732-5394 lnoble@partners.org | |
Principal Investigator: Lindsey R. Baden, MD | |
United States, Missouri | |
St. Louis University - New Hope Bldg. | Recruiting |
St Louis, Missouri, United States, 63110-2500 | |
Contact: Heidi Israel, MA, RN, LCSW 314-268-5448 israelha@slu.edu | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642-0001 | |
Contact: Catherine Bunce 585-275-5744 catherine_bunce@urmc.rochester.edu | |
United States, Tennessee | |
Vanderbilt University Hospital | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Kyle Rybczyk 615-322-5641 kyle.rybczyk@vanderbilt.edu |
Study Chair: | Paul Goepfert, MD | University of Alabama at Birmingham |
Study Chair: | Christine Mhorag Hay, MD | University of Rochester |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HVTN 065, 5-P01-AI049364-05 |
Study First Received: | March 8, 2006 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00301184 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity HIV Preventive Vaccine HIV DNA Vaccine Modified Vaccinia Ankara Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Poxviridae Infections Vaccinia HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome DNA Virus Infections Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Vaccinia Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Poxviridae Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |