Herpes Zoster (HZ) is estimated to affect between 600,000 to 1 million people annually in the United States. The incidence and severity of HZ, as well as the frequency and severity of its complications, increase markedly with age. Antiviral therapy has modest impact on the acute phase of HZ. However, it does not appear to prevent post herpetic neuralgia, the most common complication of HZ. During the past decade studies have revealed a close temporal relation between the age-related increase in the incidence and severity of HZ and an age-related decline in cell mediated immunity to varicella-zoster virus (VZV). The administration of a live attenuated varicella-zoster vaccine to older adults results in a marked and long lasting increase in VZV-specific cell-mediated immunity. We hypothesize that by boosting VZV-specific cellular immune responses, the incidence and severity of HZ and its complications can be reduced. Named the Shingles Prevention Study (SPS), this major clinical research study is a five-year, nationwide trial being conducted at 22 study sites, and enrolled a total of 38,546 volunteers. Of these individuals, 1,741 were vaccinated at the NIH Clinical Center. The enrollment period lasted from November 1998 to July 2001. At our site, the study received IRB approval on 5/3/99 and the first patient was enrolled on 6/15/99. Reactions to the vaccine were monitored passively by phone and actively in a 6000-subject subset. Surveillance of the enrollees was performed by a monthly automatic phone system. Patients reporting a zoster-like illness (either into this system or by calling directly) are examined and tested for VZV. The study is now closed and the database is being prepared for analysis. We hope to have the results available by early next year. An ammendment to continue follow up of subjects until results are available have been submitted to the IRB. The objectives of this amendment are (1) to continue the follow-up of a subset of subjects in the main efficacy study in order to accrue additional information on the persistence of vaccine efficacy during the interim period between the efficacy study close-out and the completion of the data analysis; and (2) to preserve a subset of the main efficacy study cohort during this interim period to facilitate the initiation of a long-term vaccine efficacy persistence study, should one be implemented.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Intramural Research (Z01)
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Oxman, M N; Levin, M J; Johnson, G R et al. (2005) A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 352:2271-84
Straus, S E (2001) Varicella-zoster virus immunity and prevention: a conference perspective. Arch Virol Suppl :173-8