Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), will present the Institute's strategic plan for HIV vaccine research and development in a special lecture at the 8th Conference on Advances in AIDS Vaccine Development in Bethesda, Md., on Feb. 12 at 8:30 a.m.
Dr. Fauci will also discuss the NIAID HIV vaccine plan during a science writers' briefing at 12:30 p.m. on Feb. 12. The strategy is discussed in detail in a new document entitled NIAID HIV/AIDS Vaccine Research and Development: Strategy and Opportunity, available at the conference or from the NIAID Office of Communications.
Developing a safe and effective vaccine against HIV is critical to our efforts to control the devastating pandemic of HIV and AIDS," says Dr. Fauci. "Over the past year, in an effort led by Dr. Jack Killen, director of the NIAID Division of AIDS, and his staff, the Institute has formulated a flexible strategic plan, with an integrated program of fundamental and empiric research, to facilitate the most efficient development of an HIV vaccine."
This plan provides a framework for the decision-making process in the development of any candidate vaccine, from basic research through preparations for large-scale efficacy trials," he adds.
NIAID's HIV vaccine development strategy is predicated on the notion that a safe and effective HIV vaccine can be developed, and contains four central elements:
1. Maintaining a scientific program that integrates fundamental research and empiric development to advance a broad front of critical knowledge and a variety of vaccine designs.
2. Developing partnerships between NIAID and industry sponsors of vaccine development.
3. Identifying and exploiting scientific opportunities to accelerate HIV vaccine research.
4. Strengthening linkages with individuals and organizations in the community.
"Despite considerable scientific challenges, unique social and ethical considerations, and market forces that are not especially favorable, we are optimistic that a useful HIV vaccine can be developed," says Dr. Fauci.
"First of all, we know from animal models, imperfect though they may be, that vaccine-induced protection against HIV is possible. Second, several lines of evidence suggest that the immune system is capable of impacting both initial infection with HIV and the progression of disease. Third, sexual transmission of HIV is relatively inefficient, which suggests that products that evoke responses at the mucosal surfaces could have an important impact. Fourth, in preliminary clinical trials in people, HIV vaccines have been well-tolerated and immunogenic. Finally, studies of several high-risk populations in this country and abroad suggest that it will be possible to enroll the large numbers of individuals necessary for a large-scale efficacy trial of HIV vaccines."
The ultimate goal of the NIAID vaccine program, says Dr. Fauci, is an "ideal" vaccine that:
1. Prevents initial infection and/or subsequent disease.
2. Is safe and well-tolerated.
3. Induces a broadly reactive and durable immune response.
4. Provides protection against exposure at mucosal surfaces and through blood.
5. Is easily administered, transportable and stable in storage.
"It must be noted that a less-than-ideal vaccine would probably also have a substantial positive public health impact," says Dr. Fauci. "It is also very likely that progress toward the ultimate goal of an "ideal" vaccine will occur in incremental steps in which important lessons are learned from less-than-perfect vaccines."
Critical to the development of an HIV vaccine is the cooperation of government and the pharmaceutical/biotechnology industries.
"NIAID believes that developing strong private-public sector partnerships and a vigorous level of industrial activity are pivotal to progress in this field," says Dr. Fauci. "Toward this end, we are formulating joint development plans with our industrial partners, with specific, prospectively defined scientific milestones for different vaccine approaches."
One example of such a joint development plan is the partnership with Pasteur-Meriuex-Connaught and Biocine, in which NIAID is working on a "prime-plus-boost" protocol whereby individuals are immunized with a canarypox that is genetically engineered to express HIV proteins, followed by a booster of the same vaccine given together with recombinant HIV envelope protein, or an HIV core protein.
"This partnership is a prime example of a paradigm in vaccine development in which government and industry will work closely together, and in which scientific criteria for further development of a vaccine approach will be agreed upon in advance."
The NIAID also continues to devote considerable energy to strengthening collaborative interactions with other public and private organizations, such as community and activist groups, foundations and international bodies.
NIAID is a component of the National Institutes of Health. NIAID conducts and supports research aimed at preventing, diagnosing and treating illnesses such as AIDS and other sexually transmitted diseases, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Public Health Service, part of the Department of Health and Human Services.
Further Reading: National Institute of Allergy and Infectious Diseases, Division of AIDS. NIAID HIV/AIDS Vaccine Research and Development: Strategy and Opportunity, November 1995.
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