ANATOMY OF A TRIAL - A HISTORICAL VIEW OF THE MONROE INACTIVATED HEPATITIS A PROTECTIVE EFFICACY TRIAL

The performance of vaccine protective efficacy trials is often more co mplex than reports of final results suggest. The current article revie ws the background, planning and preparations for the Monroe, NY, prote ctive efficacy trial of a formalin-inactivated, alum-adjuvanted hepati tis A vaccine (VAQTA(TM), manufactured by Merck Research Laboratories) . The vaccine trial was carried out at Kiryas Joel, a Hasidic Jewish c ommunity which had experienced numerous annual outbreaks in a local en vironment with similarities to day-care centers. Careful communication , and cooperation of community leadership, a flexible technical resour ce team, and knowledge of an epidemic already ongoing in a sister comm unity whose members were due to arrive for summer holidays, permitted rapid and efficient completion of the trial with a striking demonstrat ion of protection after a single vaccine dose.