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 complex than reports of final results suggest. The current article reviews the background, planning and preparations for the Monroe, NY, protective efficacy trial of a formalin-inactivated, alum-adjuvanted hepatitis A vaccine (VAQTA, manufactured by Merck Research Laboratories). The vaccine trial was carried out at Kiryas Joel, a Hasidic Jewish community which had experienced numerous annual outbreaks in a local environment with similarities to day-care centers. Careful communication, and cooperation of community leadership, a flexible technical resource team, and knowledge of an epidemic already ongoing in a sister community whose members were due to arrive for summer holidays, permitted rapid and efficient completion of the trial with a striking demonstration of protection after a single vaccine dose.