The worldwide search for an HIV vaccine received a boost today as the National Institute of Allergy and Infectious Diseases (NIAID) announced funding of nine U.S. clinical units of the new HIV Vaccine Trials Network (HVTN). The HVTN, expected to be fully established within a month, will provide a comprehensive, clinically based network to develop and test preventive HIV vaccines. In addition to the units based in the United States, participating sites will be located in sub-Saharan Africa, Asia, Latin America and the Caribbean.
"This NIAID network creates a coordinated, global framework in which to conduct clinical HIV vaccine research," says NIAID Director Anthony S. Fauci, M.D. "The HVTN will strengthen and expand our HIV vaccine studies both domestically and in countries devastated by the AIDS pandemic."
NIAID is providing over $29 million for the first year of the HVTN. The organization's clinical trials sites are coordinated by a Leadership Group that includes a Core Operations Center, which will provide administrative, technical and operational support, a Statistical and Data Management Center, and a Central Laboratory.
NIAID's HIV vaccine research program was previously centered in two separate groups: the U.S.-based AIDS Vaccine Evaluation Group (AVEG), which carried out early-stage testing of vaccine candidates, and the HIV Network for Prevention Trials (HIVNET), which conducted domestic and international trials of HIV vaccine and other prevention strategies. AVEG and HIVNET investigators, along with other scientists worldwide, underwent a competitive, peer reviewed evaluation process during the creation of the new network.
"The HVTN will build upon the many accomplishments of the AVEG and HIVNET," explains Peggy Johnston, Ph.D., NIAID's assistant director for AIDS vaccines. "The comprehensive clinical research agenda addresses many promising scientific opportunities to develop an HIV vaccine, which is ultimately the best hope for preventing the spread of HIV." Scientific creativity, along with collaboration between private industry, academia and government, are key aspects of the HVTN's design.
The HVTN will conduct all phases of clinical trials, from evaluating candidate vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. The network's web of U.S.-based units integrated with sites around the globe will allow the HVTN to expand rapidly to carry out larger scale studies of suitable vaccines. Many of the international institutions already have extensive experience in HIV prevention studies. Dr. Johnston notes, "Through the leadership of local scientists and in partnership with other stakeholders, the network's international components provide a critical capability to help identify vaccines appropriate for those regions hit hardest by AIDS."
Lawrence Corey, M.D., will lead the HVTN's Core Operations Center at the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle. Dr. Corey, head of the FHCRC's Infectious Diseases Program and professor of medicine and laboratory medicine at the University of Washington, says, "We have assembled an exceptionally strong and talented clinical and laboratory research team that is uniquely qualified to meet the many challenges facing the HIV vaccine effort." The network's Statistical and Data Management Center, led by Steve Self, Ph.D., will also be located at the FHCRC. Kent Weinhold, Ph.D., will direct the Central Laboratory at Duke University in Durham, North Carolina.
The following investigators head the domestic sites participating in the HVTN:
- Robert Belshe, M.D. - Saint Louis University, Missouri
- William Blattner, M.D. - University of Maryland, Baltimore
- Donald Burke, M.D. - Johns Hopkins University, Baltimore, Maryland
- Susan Buchbinder, M.D. - San Francisco Department of Health, California
- Raphael Dolin, M.D. - Harvard University, Boston, Massachusetts
- Barney Graham, M.D., Ph.D. - Vanderbilt University, Nashville, Tennessee
- Michael Keefer, M.D. - University of Rochester, New York
- Julie McElrath, M.D. - Fred Hutchinson Cancer Research Center and University of Washington, Seattle
- Mark Mulligan, M.D. - University of Alabama at Birmingham
NIAID is also convening a National HIV Vaccine Communications Steering Group to stimulate and enhance the national dialogue concerning HIV preventive vaccines. The Steering Group, composed of HIV vaccine advocates and communications specialists, will work closely with the HVTN to create a supportive environment for future vaccine studies.
Besides the HVTN, NIAID is also establishing a parallel network, the HIV Prevention Trials Network (HPTN), which will conduct research on a broad range of HIV prevention strategies. Domestically and internationally, the HPTN will evaluate and test microbicides and other promising biomedical and behavioral interventions, including vaccines to prevent transmission of HIV from mother to infant.
NIAID is a component of the National Institutes of Health (NIH). NIAID conducts and supports research to prevent, diagnose and treat illnesses such as HIV disease and other sexually transmitted diseases, tuberculosis, malaria, asthma and allergies. NIH is an agency of the U.S. Department of Health and Human Services.
Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.