February 2004

NIAID's HIV Vaccine Trials Network (HVTN)

An estimated 5 million new HIV infections occurred worldwide in the year 2003. Deaths from HIV/AIDS-related illnesses in the same year numbered approximately 3 million people, most of whom were in developing countries. With these staggering statistics in mind, researchers are working fervently in their search for an HIV vaccine. Because a preventive vaccine is the best tool for halting the spread of HIV infections throughout the world, the National Institute of Allergy and Infectious Diseases (NIAID) regards the discovery and development of a preventive HIV vaccine a top priority in its research agenda.

Clinical HIV vaccine research at NIAID is carried out through the HIV Vaccine Trials Network (HVTN), a global HIV vaccine research network established in 2000 to foster the development of HIV vaccines through testing and evaluating candidate vaccines in clinical trials. The network includes more than 25 sites in the United States, Africa, Asia, South America, and the Caribbean. HVTN's global capacity allows for rapid expansion as more vaccine candidates enter the pipeline for testing and development and for carrying out larger scale studies of promising candidate vaccines. The HVTN infrastructure is composed of an operations center that provides administrative, technical, and operational support to the network; a Statistical and Data Management Center; and a Central Laboratory. The network also collaborates with private industry, academia, and other government agencies to conduct vaccine trials.

The HVTN conducts all phases (I, II, and III) of clinical research.

Phase I Trials – Phase I studies of HIV vaccine candidates test vaccines for safety and ability to stimulate an immune response in small numbers of HIV-negative healthy participants and provide data that assists in determining which vaccines should be advanced into larger Phase II trials.

Phase II Trials – Phase II studies expand upon testing in Phase I trials, seeking additional safety data, information about optimal dosage and scheduling of vaccinations, and further information regarding the body's immune response. These trials may include individuals at higher risk of infection such as injection drug users and people who have unprotected sex and/or multiple sex partners, as well as those at lower risk of HIV infection.

Phase III Trials – Phase III efficacy studies will be conducted on a large scale at HVTN sites around the world in people who engage in high-risk behaviors. These trials require enrollment of several thousand volunteers. This is the only phase of vaccine research that seeks to answer the question of whether the candidate vaccine prevents HIV infection.

The participation of international sites and the involvement of men and women from racially and ethnically diverse populations are critical components of NIAID's HIV vaccine effort. Such diverse populations allow for studies that examine differences in genetic background, age, nutritional status, effects of other infections, and access to health care, all of which are factors crucial to developing an effective vaccine for use around the world. The international capacity of the network also facilitates studies of various HIV subtypes that affect certain populations but nonetheless may be important to developing a vaccine that will protect people from different circulating strains of the virus.

In addition to conducting clinical studies, HVTN initiates community outreach programs to educate communities about HIV vaccine research and to encourage participation in clinical trials. Through these efforts, HVTN works to enroll a diverse population in its clinical trials, with an emphasis on recruiting minorities and women. Community engagement is essential, and HVTN works to condition the environment to support the research effort and to support those who volunteer as trial participants.

NIAID funds other HIV vaccine research through its investigator-supported research grants, its Vaccine Design Development Teams, as well as through the Vaccine Research Center. NIAID also supports the National HIV Vaccine Communications Steering Group, which is composed of representatives from community-based organizations, HIV vaccine advocates, and communications consultants. The Steering Group complements HVTN outreach and communications activities on a national scale, focusing specifically on stimulating communication about the issues surrounding HIV vaccine research and promoting a positive environment for conducting clinical trials.

The domestic and international clinical sites and their principal investigators are listed below.

United States

• Alabama
  University of Alabama at Birmingham-Mark Mulligan, M.D.
• California
  Mount Zion Hospital, San Francisco-Susan Buchbinder, M.D.
  San Francisco Department of Public Health, San Francisco General Hospital-Susan Buchbinder, M.D.
• Maryland
  Johns Hopkins University, Baltimore-Donald Burke, M.D.
  University of Maryland, Baltimore-William Blattner, M.D.
• Massachusetts
  Harvard University-Brigham and Women's Hospital, Boston-Raphael Dolin, M.D.,
  Lindsay Baden, M.D
  Fenway Community Health, Boston-Kenneth Mayer, M.D.
• Missouri
  Saint Louis University-Robert Belshe, M.D.
• New York
  Columbia University, New York City-Scott Hammer, M.D.
  New York Blood Center-Union Square, New York City-Beryl Koblin, Ph.D.
  New York Blood Center-Bronx, New York City-Beryl Koblin, Ph.D.
  University of Rochester-Michael Keefer, M.D.
• Puerto Rico
  Universidad de Puerto Rico, San Juan-Carmen Zorrilla, M.D.
• Rhode Island
  Miriam Hospital, Providence-Kenneth Mayer, M.D.
• Tennessee
  Vanderbilt University, Nashville-Peter Wright, M.D.
• Washington
  Fred Hutchinson Cancer Research Center and
  University of Washington, Seattle-Julie McElrath, M.D.

International

• Botswana
  Botswana-Harvard Partnership for HIV Research and Education, Princess Marina Hospital,
  Gaborone-Myron Essex, D.V.M., Ph.D.
  Jwaneng Mining Hospital, Jwaneng, Botswana-George Seage, Ph.D.
• Malawi
  Malawi College of Medicine, Blantyre-Taha E. Taha, M.D., Ph.D., and Richard Pendame, M.D.
• South Africa
  South African Medical Research Council, Durban-Glenda Gray, M.D.
  Chris Hani Baragwanath Hospital, Soweto-Glenda Gray, M.D.

Asia

• China
  Guangxi Health and Anti-Epidemic Center, Guangxi-Jie Chen, M.D.
  Center for Disease Control and Prevention of Yunnan, Kunming, Yunan China-Dr. Lu Lin
• India
  National AIDS Research Institute, Pune-Ramesh Paranjape, M.D.
• Thailand
  Research Institute for Health Sciences, Chiang Mai-Thira Sirisanthana, M.D.

South America and the Caribbean

• Brazil
  Hospital Escola Sao Francisco de Assis, Rio de Janeiro-Mauro Schechter, M.D., Ph.D.
  Centro de Referencia e Treinamento-DST/AIDS, Sao Paolo-Artur O. Kalichman, M.D., M.P.H.
• Dominican Republic
  Centro Orientacion Integral/Instituto Dermatologica, Santo Domingo-Luis Moreno, M.D.,
  Claudio Volquez, M.D.
• Haiti
  GHESKIO, Port-au-Prince-Jean William Pape, M.D.
• Peru
  Associacion Civil Impacta Salud y Educacion, Lima-Jorge Sanchez, M.D., M.P.H.
  Medical Center SELVA AMAZONICA, Iquitos-Jorge Sanchez, MD, MPH
• Trinidad and Tobago
  Medical Research Foundation of Trinidad and Tobago, Port of Spain-Noreen Jack, M.D.
• Jamaica
  Comprehensive Health Center, Kingston, Jamaica-Peter Figueroa, M.D.

MORE INFORMATION

Further information about the HVTN is located at www.hvtn.org.

AIDSinfo is a comprehensive resource for up-to-date information on government- and industry-sponsored HIV/AIDS treatment and prevention clinical trials. AIDSinfo also maintains the most current, federally approved guidelines for treating and preventing HIV/AIDS and AIDS-related illnesses in adults and children, for managing occupational exposure to HIV, and for preventing HIV transmission from mother-to-child during pregnancy. AIDSinfo has a great deal of information in Spanish and provides links to other Spanish language resources, which can be accessed through the home page.

AIDSinfo is sponsored by NIAID, National Institutes of Health Office of AIDS Research, National Library of Medicine, Centers for Disease Control and Prevention, Health Resources and Services Administration, and Centers for Medicare and Medicaid Services.

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NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted infections, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892

U.S. Department of Health and Human Services

Department of Health and Human Services

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