TRIAL OF VARICELLA ZOSTER VACCINE FOR PREV OF HERPES ZOSTER COMPLICATIONS

水痘带状疱疹疫苗预防带状疱疹并发症的试验

• 批准号: 7378160
• 负责人: GEORGE CRAWFORD
• 金额: $ 10.57万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378160
• 关键词: TRIAL; VARICELLA; ZOSTER; VACCINE; PREV

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：最初研究的主要目的是确定接种减毒水痘-带状疱疹活疫苗（OKA/默克株）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））的发病率和/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。研究计划：从整个贝尔县和弗吉尼亚州招募年龄在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了广泛的教育后，研究人员每月联系受试者，至少进行了4年的随访，以确定他们是否有带状疱疹的临床症状。每个中心在18-24个月内招募了1800名受试者，总入组人数约为37200人。主要研究者对可能患有带状疱疹的受试者进行评估，如果受试者在出现带状疱疹皮疹后72小时内出现，则使用抗病毒药物泛昔洛韦进行治疗。随访受试者以寻找PHN的证据。方法：所有疑似HZ病例由临床评估委员会（CEC）采用盲法确诊。他们最初只回顾了每个疑似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。在所有微生物学检测结果完成后，CEC再次审查每个疑似HZ病例。微生物确证研究包括在第1天进行水痘-带状疱疹病毒（VZV）的病毒培养，同时用拭子拭子检测VZV抗原的直接荧光抗体（DFA），用PCR检测VZV DNA和HSV DNA，用糖蛋白抗原酶联免疫吸附试验（gpELISA）检测VZV抗体的血清，在基线和第3周和第6周用乳胶凝集（LA）检测VZV抗体。