Lyme disease is an emerging infection that has now become the most commonly reported vector-borne disease in the United States. In the 20 years since its initial description, scientific and technological advances have led to candidate vaccines for the prevention of Lyme disease. Recombinant outer surface protein A (OspA) vaccines have been successful in protecting mice in tick-challenge experiments. A candidate OspA vaccine has been found to be safe and immunogenic in phase I and II studies. This article describes some of the lessons that were learned and some of the unique obstacles encountered in the design and implementation of a large phase III efficacy field trial. Pivotal trials of vaccines for Lyme disease can be a major investment of time and resources for subjects, investigators, and sponsors. If properly conducted, they also present unique opportunities to expand our knowledge of the disease.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.