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NIAID launches first Phase II trial of a 'global' HIV/AIDS vaccine

A novel vaccine targeted to multiple HIV subtypes found worldwide has moved into the second phase of clinical testing, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced today. The study investigators plan to enroll a total of 480 participants at sites in Africa, North America, South America and the Caribbean to test the safety and immune response to the vaccine.

The experimental vaccine was developed by scientists at NIAID's Dale and Betty Bumpers Vaccine Research Center (VRC) and is being studied in the HIV Vaccine Trials Network (HVTN), a clinical research collaboration funded by NIAID's Division of AIDS (DAIDS).

"This trial marks an important step in the advancement toward an AIDS vaccine. The rapid development of this candidate vaccine--less than five years since the launch of the VRC--underscores our commitment to hasten the day when we have an effective AIDS vaccine," says NIAID Director Anthony S. Fauci, M.D.

The unique vaccine combines synthetically modified elements of four HIV genes found in subtypes A, B and C of the virus--the subtypes commonly found in Africa, the Americas, Europe and parts of Asia. These subtypes represent about 85 percent of HIV infections worldwide.

"This is the first Phase II study of a vaccine candidate that is broadly relevant to the global AIDS pandemic because it combines components of HIV strains found throughout the world," says VRC Director Gary Nabel, M.D., Ph.D. "We look forward to working with our partners in the United States and abroad as we take this vaccine into the next phase of clinical evaluation."

The trial, known as HVTN 204, is being coordinated with two other planned clinical studies, an unprecedented collaboration among researchers in three clinical trial networks and NIAID. The International AIDS Vaccine Initiative plans to conduct a Phase I study of the VRC vaccine at sites in Kenya and Rwand
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Contact: NIAID News Office
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
11-Oct-2005


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