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The WHO and Why of HIV Vaccine Trials

Nature (11/24/94) Vol. 372, No. 6504, P. 313
Moore, John; Anderson, Roy


John Moore of the Aaron Diamond AIDS Research Center and Roy Anderson of the Centre for the Epidemiology of Infectious Diseases discuss the reasoning behind the World Health Organization (WHO) advisory committee's decision to approve Phase III HIV vaccine trials in developing countries. Ninety percent of the 16 million people estimated by the WHO to be HIV-infected live in poor communities in the developing world. While the main concern of the committee members was that the products would not work, clinicians and epidemiologists argued that the only way to determine efficacy is to run an efficacy trial. The WHO committee concluded that, ultimately, any decision to go ahead with a trial of any product must be made by the host country for the trial. Phase I/II safety trials should precede a Phase III trial. The panel also stated that the specific HIV-1 subtypes among the proposed trial population should be a significant consideration, as should counseling of the trial populations about the potential risks of vaccination and the necessity of following safe sex practices. The WHO committee emphasized a long-term commitment to AIDS vaccine development and testing worldwide.


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