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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Centers for Disease Control and Prevention HIV Vaccine Trials Network International AIDS Vaccine Initiative U.S. Military HIV Research Program |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00498056 |
The development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.
Condition | Intervention | Phase |
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HIV Infections |
Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP Biological: VRC-HIVDNA016-00-VP placebo Biological: VRC-HIVADV014-00-VP placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons |
Estimated Enrollment: | 8500 |
Study Start Date: | July 2007 |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP. Injections will occur at study entry and Weeks 4, 8, and 24.
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Biological: VRC-HIVDNA016-00-VP
DNA vaccine administered intramuscularly
Biological: VRC-HIVADV014-00-VP
Adenovirus vaccine administered intramuscularly
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2: Placebo Comparator
Participants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP placebo followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP placebo. Injections will occur at study entry and Weeks 4, 8, and 24.
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Biological: VRC-HIVDNA016-00-VP placebo
DNA vaccine placebo administered intramuscularly
Biological: VRC-HIVADV014-00-VP placebo
Adenovirus vaccine placebo administered intramuscularly
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The number of people infected by HIV-1 worldwide continues to increase. However, antiretroviral therapy is largely unavailable in low- and middle- income countries where risk of infection is very high. The development of a safe and effective vaccine to prevent HIV infection is urgently needed. This study will evaluate the effectiveness, safety, and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by an adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. Both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 75% to 85% of new HIV infections in the world. Adenoviral type 5-based vaccines have improved induction of HIV-specific CD8 cytotoxic T-lymphocyte cell responses, which correlate with lower HIV burden (viral load) and slower disease progression in primates and in HIV-1 infected people whose disease does not progress over the long term. The purpose of this study is to determine the safety and effectiveness of and immune response to a series of multiclade DNA vaccine injections followed by a booster injection of a multiclade adenovirus vaccine against HIV-1 infection in healthy adults at risk for HIV infection in North and South America, the Caribbean, and Africa.
This study will last from about 3 years to 5 years, because the length of the study depends on how quickly people enroll and how quickly during the study new HIV-1 infections occur. Study participants will be randomly assigned to receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP, for a total of four injections of vaccine or four injections of placebo. Injections will occur at study entry and Weeks 4, 8, and 24. Prior to the study injections, participants will have their vital signs and weight measured, and blood collection will occur. Participants will be observed in the clinic for at least 30 minutes after each injection for immediate reactions to the vaccines. At all injection visits, HIV risk-reduction counseling, HIV risk assessment, pregnancy prevention counseling, and training on how to use memory cards will also occur. For 3 to 7 days after each injection, participants will be asked to record information about injection site pain, redness, size, swelling, temperature, general well-being, and headaches on their memory cards. Additional study visits will occur on Weeks 1, 12, 28, 48, 72, 96, 120, and 144. At these visits, physical examinations, blood collection, and social impact questionnaires may also be done. Any study participants who become infected with HIV while on the study will be monitored for at least 72 weeks after diagnosis or at least 12 weeks after the study reaches its primary evaluation time point (whichever is longer). The study investigators are committed to providing access to local standard of care and treatment to those study participants who are found to be HIV-1 infected.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Massachusetts | |
Harvard Medical School - Brigham & Womens Hospital | |
Boston, Massachusetts, United States, 02115 | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Wake County Health and Human Services | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
FHCRC/UW - Vaccine Trials Unit | |
Seattle, Washington, United States, 98104 |
Study Chair: | Scott M. Hammer, MD | Columbia University |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PAVE 100 |
Study First Received: | July 5, 2007 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00498056 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |