Preparations for HIV vaccine trials: moving from baseline studies to efficacy trials

In summary, much has been accomplished in the past year, but much still remains to be done before we can embark on an efficacy trial. With the availability of a fully operational network, the NIAID has in place the resources and mechanisms to complete baseline feasibility studies and to conduct the future trials. As presented at the 1993 conference and reported in this supplement, the preliminary data from the current baseline studies indicate that such trials are feasible, although not without considerable problems. To reach our "efficacy trials preparedness" goal, we will need to work especially hard in the coming months to identify and resolve the remaining technical, ethical, legal, and political constraints to initiating trials. We must also listen to community concerns and educate the public about the trials if we expect to gain community support and volunteers for the study. Finally, we must evaluate the supporting data pertaining to candidate products for efficacy trials. These will not be easy tasks or decisions, but we must approach them with vigor.