This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVES: The primary objective of the original study was to determine whether immunization with live-attenuated Varicella-Zoster vaccine (OKA/Merck strain) can reduce the incidence and/or severity of herpes zoster (HZ) and its complications, primarily post-herpetic neuralgia (PHN), in persons 60 years of age and older. This will be accomplished by comparing a measure of the burden of illness due to HZ and PHN in vaccine and placebo recipients. RESEARCH PLAN: Individuals were recruited from throughout Bexar County and the VA region who were 60 years of age or older with a history of Varicella or long term (30 years) residence in the continental US. Subjects were randomized to received the Varicella vaccine or placebo in a double blinded fashion. After extensive education regarding the clinical presentation of herpes zoster, subjects were contacted monthly for a minimum of 4 years of follow-up to ascertain whether they had a clinical syndrome suggestive of zoster. 1800 subjects were recruited from each center over 18-24 months with a total enrollment of approximately 37,200. Subjects with possible zoster were evaluated by the principal investigator and treated with the antiviral agent, famciclovir, if the subject presented within 72 hours of the onset of the zoster rash. Subjects were followed for evidence of PHN. METHODS: All suspected cases of HZ were confirmed in a blinded fashion by the Clinical Evaluation Committee (CEC). They initially reviewed only the clinical history of each suspected HZ case and made a determination whether there was or was not HZ based upon the study definition of a clinical case of HZ. Each suspected HZ case was reviewed again by the CEC after all of the microbiologic test results were complete. Microbiologic confirmatory studies include viral culture for Varicella-zoster virus (VZV) on day 1 along with swab of the lesion for direct fluorescent antibody (DFA) for VZV antigen, and PCR for VZV DNA and HSV DNA, serum for VZV antibody by glycoprotein antigen based enzyme-linked immunosorbent assay (gpELISA) and by latex agglutination (LA) at baseline and 3 and 6 weeks.
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