Phase III trial to determine correlates of protection will not proceed.(Brief Article)

2002 APR 3 - (NewsRx.com & NewsRx.net) -- Two recent decisions will substantially contribute to a coordinated and comprehensive U.S. government effort to develop preventive HIV vaccines, according to the National Institute of Allergy and Infectious Diseases (NIAID).

NIAID, part of the National Institutes of Health (NIH), and the U.S. Army Medical Research and Materiel Command (USAMRMC) of the Department of Defense (DoD), support a broad, comprehensive HIV/AIDS research and development program.

On January 4, 2002, the White House Office of Management and Budget directed the transfer of oversight and management for the DoD HIV Research and Development Program of USAMRMC to the NIH. NIAID, which has the primary responsibility for HIV/AIDS research within the NIH, will assume responsibility for this program beginning October 1, 2002. Both the NIH and USAMRMC are committed to maintaining and building on the various strengths of each program. The Henry M. Jackson Foundation for the Advancement of Military Medicine, a private, nonprofit organization that works closely with the Walter Reed Army Institute for Research (WRAIR), a subordinate laboratory of USAMRMC, will be a resource for both programs.

NIAID and USAMRMC have a common goal: to prevent the further spread of HIV/AIDS by developing safe and effective vaccines, other prevention strategies and innovative HIV treatments. The research activities of both groups are complementary and will be effectively integrated. The major difference between the two is the constituencies they serve: the USAMRMC research program primarily serves young, healthy adults on active military duty who are subject to worldwide deployment, while the NIAID research program serves all civilian age groups and addresses all HIV-associated conditions, such as opportunistic infections and other AIDS complications. NIAID will continue to support HIV research and development that is deemed relevant and supportive of the military mission.

USAMRMC's experience conducting international drug and vaccine development and testing and its established collaborative ties in many parts of the world will enhance NIAID's expanding international efforts. In turn, USAMRMC programs will benefit from NIAID's vast HIV/AIDS preclinical research program, which is integrated into NIAID's comprehensive HIV/AIDS research effort.

Since 1993, NIAID and USAMRMC have collaborated significantly on complementary research programs. Most recently, NIAID provided funds to USAMRMC to renovate and construct specialized facilities designed for HIV vaccine production. The two Institutes are also collaborating on a large international clinical trial of IL-2 in people infected with HIV. By formally integrating the experience, expertise, research infrastructure and resources of both Institutes, the merger will ensure the U.S. government HIV research effort is comprehensive, efficient and coordinated.

Until recently, NIAID and USAMRMC had proposals under way to begin large-scale, phase III HIV vaccine efficacy trials in the near future. Both trials were to test similar "prime-boost" vaccine combinations (a canarypox-virus-based primer vaccine followed by a gp120 subunit booster vaccine), although the vaccines were slightly different; the trials were designed to ...