The National Institute of Allergy and Infectious Diseases (NIAID), the leading HIV research component of the United States government, has entered into an agreement with Merck & Co. to collaborate on human testing of promising candidate HIV vaccines developed by the company. Under an agreement signed this week, the vaccines will be evaluated in collaboration with NIAID's international HIV Vaccine Trials Network (HVTN), a group of more than two dozen clinical sites worldwide established to rapidly move promising experimental HIV vaccines through all stages of human testing.
Merck will continue its ongoing HIV vaccine development program, which includes a number of independent trials that are under way or planned. Merck will also provide HVTN with certain proprietary scientific tools and methodologies that can be adopted for use in the evaluation of other, competing vaccines."
"Scientists in industry, academia and government have unique and necessary contributions to make to the important work of developing a vaccine against HIV," says NIAID Director Anthony S. Fauci, M.D. "Public-private partnerships such as this bring our collective strengths to bear on one of the world's most serious health problems."
With an estimated 5 million new HIV infections worldwide this year about 14,000 each day developing a vaccine against HIV is a top biomedical research priority. Because 95 percent of those infections occur in people living in developing countries, vaccine development must include strategies for testing vaccine candidates in those regions.
NIAID established the HVTN in 2000 to combine its domestic and international HIV vaccine clinical trials programs and build the necessary infrastructure to quickly evaluate promising products, such as the Merck vaccine. Today, the network includes 12 sites at academic centers in the United States and 13 at overseas institutions, including sites in Africa, Asia, South America and the Caribbean. Participation of international sites and the involvement of ethnically diverse populations in the HVTN support studies that examine differences in genetic background, nutritional status and effects of different HIV strains, all of which may prove important to the safety and effectiveness of HIV vaccines. To date, 30 potential HIV vaccines have been evaluated in NIAID-supported clinical trials.
Merck began testing their vaccines in humans in late 1999. Further tests will be needed before the vaccines can be evaluated for their clinical utility in much larger numbers of people.
Discussions of collaboration resulted from the suggestion by NIAID earlier this year that Merck use the HVTN as a means of testing Merck candidate vaccines. The agreement offers the company access to the network's clinical testing expertise, including protocol design, immune response analysis, regulatory guidance, and data and safety monitoring for Phase I, II and III clinical trials.
"The HVTN comprises the most experienced vaccine trial researchers in the world," says Peggy Johnston, Ph.D., NIAID's assistant director for HIV vaccines. "The combined strengths of Merck, NIAID's HVTN, and other components of NIAID will facilitate rapid progress in evaluating the safety, immunogenicity and efficacy of these vaccines."
Larry Corey, M.D., who leads the network from the Fred Hutchinson Cancer Research Center in Seattle, adds, "A goal of the HVTN is to obtain comparative information on all promising HIV vaccine candidates. The laboratory strengths of the HVTN and Merck will help ensure this objective continues to be met."
NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, 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.