TRIAL OF VARICELLA ZOSTER VACCINE FOR PREV OF HERPES ZOSTER COMPLICATIONS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。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)能否降低60岁及以上人群带状疱疹(HZ)及其并发症(主要是带状疱疹后神经痛(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造成的疾病负担的衡量标准来实现。研究计划：从整个贝克萨尔县和弗吉尼亚州地区招募年龄在60岁或以上、有水痘病史或在美国大陆长期居住(30年)的人。受试者随机接受水痘疫苗或安慰剂双盲接种。在对带状疱疹的临床表现进行广泛的教育后，研究人员每月联系受试者，进行至少4年的随访，以确定他们是否有带状疱疹的临床症状。在18-24个月的时间里，从每个中心招募了1800名受试者，总登记人数约为37200人。可能患有带状疱疹的受试者由首席调查员进行评估，如果受试者在带状疱疹发病72小时内出现，则用抗病毒药物泛昔洛韦进行治疗。受试者被跟踪以寻找PHN的证据。方法：临床评价委员会(CEC)对所有疑似HZ病例进行盲法确诊。他们最初只审查了每个疑似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。在所有微生物检测结果完成后，CEC再次对每一例疑似HZ病例进行审查。微生物学验证性研究包括第1天的水痘-带状疱疹病毒(VZV)病毒培养和皮损拭子直接荧光抗体(DFA)，以及VZV DNA和HSV DNA的聚合酶链式反应(PCR)，血清VZV抗体的检测采用基于糖蛋白抗原的酶联免疫吸附试验(GpELISA)和乳胶凝集(LA)。

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.