October 11, 2005 -- 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 NIAIDs 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 NIAIDs 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 the 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 Rwanda, and the U.S. Military HIV Research Program plans Phase I and II studies at sites in Uganda, Kenya and Tanzania; the studies are contingent on the appropriate regulatory and ethical approvals being granted in these countries.

About the Vaccine
The three harmonized trials will be testing a prime-boost strategy composed of two vaccine components given at different times. Both contain synthetic versions of four HIV genes: gag, pol, nef and env. The gag, pol and nef genes come from HIV subtype B, the primary virus found in Europe and North America. Env, the fourth gene, codes for an HIV coat protein that allows the virus to recognize and attach to human cells. The vaccine incorporates modified env genes from subtypes A and C, most common in Africa and parts of Asia, as well as subtype B.

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