THE SHINGLES PREVENTION STUDY: AN UPDATE

Michael N. Oxman, M.D., for The Shingles Prevention Study
Department of Veterans Affairs San Diego Healthcare System and the University of California, San Diego

The hypothesis that immunization of older adults will reduce the frequency and/or severity of herpes zoster (shingles) and its principal complication, postherpetic neuralgia (PHN), is based upon compelling, but circumstantial, evidence. The Shingles Prevention Study is designed to test this hypothesis. The Shingles Prevention Study is a VA Cooperative Study being carried out with the collaboration of the National Institutes of Health and Merck & Company. It is a large, double-blind, placebo-controlled clinical trial of an investigational live attenuated varicella-zoster virus (VZV) vaccine that can stimulate VZV-specific cell mediated immunity in older adults, much as an episode of shingles does. The Shingles Prevention Study is in the midst of enrolling 37,200 volunteers who are 60 years of age or older at 22 medical centers across the United States, and it has already enrolled more than 28,000 subjects. The design and execution of the Shingles Prevention Study presents a number of challenges, including the nature and size of the target population, the choice and definition of study endpoints, the development and validation of assessment tools, the measurement of VZV-specific cell mediated immunity to the investigational shingles vaccine, the recruitment of elderly subjects, and the development and implementation of methods for the active follow-up of enrolled subjects and for herpes zoster case ascertainment. These will be briefly reviewed together with the progress of the Study to date.

Corresponding Author: Michael N. Oxman, M.D., University of California, San Diego, 3350 La Jolla Village Drive (111F1), San Diego, CA 92161, USA