TRIAL OF VARICELLA ZOSTER VACCINE FOR PREV OF HERPES ZOSTER & ITS COMPLICATIONS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 目的：最初研究的主要目的是确定接种水痘-带状疱疹减毒活疫苗（OKA/Merck株）是否可以降低60岁及以上人群带状疱疹（HZ）及其并发症（主要是疱疹后神经痛（PHN））的发生率和/或严重程度。这将通过比较疫苗和安慰剂接受者中HZ和PHN引起的疾病负担来实现。 研究报告：从整个贝克萨尔县和VA地区招募60岁或以上、有水痘病史或长期（30年）居住在美国大陆的个体。受试者以双盲方式随机接受水痘疫苗或安慰剂。在对带状疱疹的临床表现进行广泛教育后，每月联系受试者至少4年随访，以确定他们是否有提示带状疱疹的临床综合征。在18-24个月内从每个中心招募了1800名受试者，总入组人数约为37，200人。由主要研究者对可能患有带状疱疹的受试者进行评价，如果受试者在带状疱疹发作后72小时内出现，则使用抗病毒药物泛昔洛韦治疗。对受试者进行PHN证据随访。 方法：所有疑似HZ病例均由临床评价委员会（CEC）以盲法确认。他们最初仅审查了每例疑似HZ病例的临床病史，并根据HZ临床病例的研究定义确定是否存在HZ。在完成所有微生物检测结果后，CEC再次审查了每例疑似HZ病例。微生物学确证性研究包括第1天水痘-带状疱疹病毒（VZV）的病毒培养沿着VZV抗原的直接荧光抗体（DFA）的病变拭子，VZV DNA和HSV DNA的PCR，通过基于糖蛋白抗原的酶联免疫吸附试验（gpELISA）和基线及3周和6周的乳胶凝集（LA）检测VZV抗体的血清。

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.