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Specific issues in the design and implementation of an efficacy trial for a Lyme disease vaccine.

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Abstract

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.

Clin Infect Dis. 1997 Jul;25 Suppl 1:S71-5.

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