Leading Scientists, Policy Makers, AIDS Advocates Develop ‘Road Map’ for HIV-Vaccine Development
Twenty-four of the world's "AIDS elite," including U.S. and international public health officials, two Nobel Prize winners, corporate and foundation researchers and advocates, today released an article in the journal Science that calls for the creation of a Global Vaccine Enterprise to speed the discovery of an effective HIV vaccine, the Washington Post reports (Kaufman, Washington Post, 6/27). Despite "extensive progress" in antiretroviral treatment and reduction of mother-to-child HIV transmission, development of an HIV vaccine has "lagged," they say (Klausner et al., Science, 6/27). So far, only VaxGen's AIDSVAX has progressed to clinical trials, and the long-anticipated results showed it to be overall ineffective at preventing new infections (Russell, San Francisco Chronicle, 6/27). Researchers have been unable to overcome the inability of current vaccine designs to stimulate effective antibodies against various strains of the virus or to prevent HIV from establishing "persistent infection." In addition, the unique pace of the epidemic and its toll on international, political and economic health leaves the scientific community with no precedent on which to base the large-scale "well-coordinated global enterprise" that is required to execute a worldwide vaccine research program (Science, 6/27). The high cost of a vaccine develoment program and the risk of failure coupled with uncertain markets in the developing countries that most need the vaccine make it unrealistic to expect the private industry to "shoulder the burden [of vaccine development] alone," according to the Wall Street Journal (Chase/Bank, Wall Street Journal, 6/27). According to the writers, the most efficient means of solving these scientific challenges is to utilize the "creativity of individual scientists working together in multidisciplinary consortia" and linking the consortia in a "high-quality collaborative research system" that surpasses the "high-quality but separate" projects in existence today. To achieve this end, the writers propose the development of a "roadmap" for a Global Vaccine Enterprise with the following components:
- Vaccine Development Centers: In order to increase the diversity of approaches to the design of a vaccine and to coordinate the types of vaccines entering clinical trials, it is necessary to create a "series of coordinated global HIV vaccine centers," the writers say. "The core of an integrated approach to HIV vaccine development would begin by conceiving of the world of potential vaccine concepts as a grid, with each cell [in the grid] representing a particular approach" to vaccine development. As many Vaccine Development Centers as are needed to cover every possible "cell" on that grid should be created. While the structure of the centers may vary, they should each have sufficient researchers, a sense of long-term commitment and resources to perform meaningful research.
- Vaccine Science Consortia: In order to solve the "fundamental scientific questions impeding AIDS vaccine development [that] have remained unchanged and unsolved since the identification of HIV," the writers suggest the creation of Vaccine Science Consortia, each dedicated to solving a particular vaccine-related scientific problem.
- Vaccine Manufacturing Capacity: Because vaccine research has been primarily funded, conducted and driven by small biotechnology companies, not-for-profits and academic institutions, who have little experience in large scale vaccine manufacturing, it is crucial that the private sector become involved in expanding the production vaccines "to the standards needed for clinical trials."
- Standardized Assessment of Preclinical and Clinical Research Results: In order to ensure that the most promising vaccine candidates are selected for clinical trial, the Global Vaccine Enterprise will need to standardize the preclinical evaluation process.
- Expansion of Integrated, International Clinical Trials System: While "large, comprehensive, international clinical trials" have been conducted by several groups and agencies, it is necessary to expand and integrate this system, the writers say. In order for trials to be successful in the developing world, clinical trial partnerships must engage "local investigators, communities, ethical review committees, and regulatory bodies" in conjunction with national HIV/AIDS programs, the writers say.
- Optimizing Interactions Among Regulatory Authorities: Regulatory bodies in participating countries should share their evaluation of preclinical and clinical trial information and should recognize the "regional variations in the social, economic and health burdens of HIV," of their respective countries.
The writers conclude that the "time is right for the major scientific and product development leaders and the stakeholders involved in the global HIV vaccine development enterprise to come together in an analogous way." All those involved in the enterprise must help to "prioritize the scientific challenges to be addressed," develop an implementation plan for each component of the system and identify the resources needed for each to be successful. Funders and major stakeholders should "agree to a common vision" in order to coordinate their activities. Finally, the enterprise "must be a global effort" building on the "full participation of the developing world," the writers say (Science, 6/27). The authors now plan to break into expanded working groups to develop the Enterprise and flesh out the details of the road map, Richard Klausner, lead author of the article and executive director of global health for the Bill & Melinda Gates Foundation, said. Anthony Fauci, co-author of the article and director of the National Institute of Allergy and Infectious Diseases, said, "What we're trying to do in this paper is really catalyze the idea that we need a global enterprise for an AIDS vaccine" (Washington Post, 6/27).
The following people authored the opinion piece: Klausner; Fauci; Helene Gayle, Director of HIV, TB, and Reproductive Health for the Bill & Melinda Gates Foundation; Lawrence Corey, head of the Program in Infectious Diseases of the Fred Hutchinson Cancer Research Center; Gary Nabel, director of the NIH Vaccine Research Center; Seth Berkley, founder of the International AIDS Vaccine Initiative; Barton Haynes, director of the Duke University Human Vaccine Institute; David Baltimore, president of California Institute of Technology; Chris Collins, executive director of the AIDS Vaccine Advocacy Coalition; R. Gordon Douglas, president, CEO and co-founder of IAVI; Jose Esparza, coordinator of the HIV Vaccine Initiative of the WHO-Joint U.N. Program on HIV/AIDS; Donald Francis, CEO of VaxGen; N.K. Ganguly, director of the Indian Council of Medical Research; Julie Gerberding, director of the CDC; Margaret Johnston, associate director of the Vaccine and Prevention Research Program of the Division of AIDS, NIAID; Michel Kazatchkine, president of the Agence Nationale de Recherches sur le Side; Andrew McMichael, professor in the MRC Human Immunology Unit of the Weatherall Institute of Molecular Medicine, University of Oxford; Malegapuru Makgoba, president of the Medical Research Council of South Africa; Giuseppe Pantaleo, head of the Division of Immunology and Allergy, Centre Hospitalier, Universitaire Vaudois, University of Lausanne; Peter Piot, executive director of UNAIDS; Yiming Shao, deputy director of China's National Center for AIDS/STD Control and Prevention; Edmund Tramont, director of the DAIDS, NIAID; Harold Varmus, director of the NIH; Judith Wasserheit, director of the HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center (Science, 6/27).