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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) HIV Vaccine Trials Network Pharmexa-Epimmune Bavarian Nordic |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00428337 |
The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.
Condition | Intervention | Phase |
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HIV Infections |
Biological: EP-1233 Biological: MVA-mBN32 |
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 DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-Boost Regimen, When Given to Healthy, Vaccinia-Naive, HIV-1-Uninfected Adults |
Estimated Enrollment: | 108 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168
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Biological: EP-1233
DNA-HIV-recombinant vaccine
Biological: MVA-mBN32
HIV-recombinant viral vaccine
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2: Experimental
Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168
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Biological: EP-1233
DNA-HIV-recombinant vaccine
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3: Experimental
Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168
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Biological: MVA-mBN32
HIV-recombinant viral vaccine
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The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak immune response but when used as priming immunogens, followed by a recombinant viral vaccine that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a booster, immunization with such a combination regimen seems to induce much stronger responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4 (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV immunogens, may result in a stronger immune response.
The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated.
Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco Department of Public Health | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Theresa Wagner, MPH 415-621-8635 Theresa.Wagner@sdfph.org | |
Principal Investigator: Susan Buchbinder, MD | |
San Francisco Department of Public Health | Not yet recruiting |
San Francisco, California, United States, 94102-6033 | |
Contact: Rose Quinones, PA 415-544-9014 rose.quinones@sfdph.org | |
Principal Investigator: Susan Buchbinder, MD | |
Mt. Zion Hospital - GCRC | Recruiting |
San Francisco, California, United States, 94102-6033 | |
Contact: Rose Quinones, PA 415-544-9014 rose.quinones@sfdph.org | |
Principal Investigator: Susan Buchbinder, MD | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Catherine Bunce 585-275-5744 catherine_bunce@urmc.rochester.edu | |
Principal Investigator: Michael C. Keefer, MD | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Kyle Rybczyk 615-322-5641 kyle.rybczyk@vanderbilt.edu | |
Principal Investigator: Peter Farnum Wright, MD |
Study Chair: | Geoffrey Gorse | Saint Louis University School of Medicine |
Study Chair: | Christine Mhorag Hay | University of Rochester |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HVTN 067 |
Study First Received: | January 29, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00428337 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity EP1233 MVA-mBN32 HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Vaccinia HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |