PREPARING FOR HIV VACCINE EFFICACY TRIALS - PARTNERSHIPS AND CHALLENGES

Initiation of clinical efficacy trials of candidate human immunodefici ency virus (HIV) vaccines may be scientifically and ethically warrante d in the next few years. The National Institute of Allergy and Infecti ous Diseases (NIAID) is making preparations to start trials with minim al delay as soon as a suitable candidate vaccine becomes available. NI AID is sponsoring the establishment of an infrastructure for epidemiol ogical studies of populations at potential sites for such trials. In f ield trials, we will need to measure suitable end points-infection, im munological status, and clinical status-necessary to judge vaccine eff ectiveness in preventing infection and/or disease. Difficulties in rec ruiting and following high-risk populations present a major research c hallenge. The many scientific, ethical, social, legal, and political i ssues related to such trials are being addressed in partnership with m any groups, both in the United States and abroad. This partnership mus t include the public and private sectors: communities experiencing epi demic HIV spread, companies developing candidate vaccines, U.S. and in ternational agencies, universities, and governments. Effective HIV pre vention will require persistent attention to behavior change, includin g partner reduction and condom use, even as we develop and test candid ate vaccines to prevent HIV and the acquired immunodeficiency syndrome (AIDS).