Trial Of Varicella Vaccine For The Prevention Of Herpes Zoster

水痘疫苗预防带状疱疹的试验

• 批准号: 7592246
• 负责人: ADRIANA R MARQUES
• 金额: $ 17.25万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7592246
• 关键词: Acute; Advisory Committees; Affect; Age; Age-Years; Antiviral Therapy; Attenuated; Cellular Immunity; Chickenpox; Chickenpox Vaccine; Chronic; Clinical; Clinical Research; Collaborations; Complication; Elderly; Enrollment; Frequencies; Ganglia; Herpes zoster disease; Herpesvirus Type 3; Immune response; Immunity; Immunization; Incidence; Individual; Journals; Life; Manuscripts; Medicine; Myxoid cyst; Names; National Institute of Allergy and Infectious Disease; Nerve Pain; New England; Pain; Personal Satisfaction; Phase; Placebos; Postherpetic neuralgia; Prevention; Publishing; Rate; Reaction; Serious Adverse Event; Severities; Site; United States; United States Department of Veterans Affairs; United States Food and Drug Administration; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Vesicular Skin Diseases; Veterans; Virus Diseases; afferent nerve; age related; cooperative study; eligible participant; follow-up; prevent; programs; research study; vaccine efficacy; volunteer

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 hypothesized 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 was led by the Department of Veterans Affairs (VA) and carried out in collaboration with NIAID and Merck & Co., Inc. This nationwide trial was conducted at 22 study sites over a 5 1/2-years period, and enrolled a total of 38,546 volunteers. Of these individuals, 1,741 were vaccinated at the NIH Clinical Center. The vaccine reduced the incidence of shingles by 51 percent: 642 cases of shingles occurred among those in the placebo group compared with only 315 in the vaccinated group. Among all vaccine recipients, the total burden of pain and discomfort due to shingles was 61 percent lower than in placebo recipients. Moreover, the zoster vaccine reduced the incidence of postherpetic neuralgia (PHN)a form of chronic nerve pain that is the most common serious complication of shinglesby two-thirds compared with placebo. The vaccine was well tolerated, with the rates of serious adverse events low and local reactions at the vaccination site generally mild. A manuscript descibing the findings was published at the New England Journal of Medicine in June 2005. The FDA approved ZOSTAVAX for prevention of herpes zoster in individuals 60 years of age and older on May 25, 2006 and recommended by the Advisory Committee on Immunization Practices (ACIP) for people age 60 and older for prevention of herpes zoster in October 26, 2006. In the past year, we have completed the vaccination of all eligible participants that received placebo in the main study, and we are currently participating in an extension phase follow up of the individuals who received the vaccine under the main study, to accrue additional information on the persistence of vaccine efficacy.

据估计，美国每年有60万至100万人感染带状疱疹。HZ的发病率和严重程度，以及其并发症的频率和严重程度，随着年龄的增长而显著增加。抗病毒治疗对HZ急性期影响不大。然而，它似乎不能预防带状疱疹后神经痛，这是HZ最常见的并发症。在过去的十年中，研究表明，与年龄相关的HZ发病率和严重程度的增加与与年龄相关的水痘-带状疱疹病毒(VZV)细胞免疫功能下降之间存在密切的时间关系。对老年人接种减毒水痘-带状疱疹活疫苗可显著和持久地提高VZV特异性细胞免疫。我们推测，通过增强VZV特异性细胞免疫反应，可以降低HZ及其并发症的发生率和严重程度。 这项名为带状疱疹预防研究(SPS)的重大临床研究由退伍军人事务部(VA)领导，并与NIAID和默克公司合作进行。这项全国性的试验在22个研究地点进行，历时5年半，共招募了38,546名志愿者。在这些人中，有1741人在NIH临床中心接种了疫苗。该疫苗将带状疱疹的发病率降低了51%：安慰剂组发生了642例带状疱疹，而接种疫苗组只有315例。在所有疫苗接受者中，带状疱疹引起的疼痛和不适的总负担比安慰剂接受者低61%。此外，带状疱疹疫苗与安慰剂相比，将带状疱疹后遗神经痛(PHN)的发生率降低了三分之二。PHN是一种慢性神经疼痛，是带状疱疹最常见的严重并发症。该疫苗耐受性良好，严重不良事件发生率低，接种地点的局部反应一般较轻。描述这一发现的手稿于2005年6月发表在《新英格兰医学杂志》上。FDA于2006年5月25日批准Zostavax用于60岁及以上个人预防带状疱疹，并于2006年10月26日由免疫实践咨询委员会(ACIP)推荐用于60岁及以上人群预防带状疱疹。 在过去的一年里，我们已经完成了所有在主要研究中接受安慰剂的合格参与者的疫苗接种，目前我们正在参与主要研究中接受疫苗接种的个人的扩展阶段跟踪，以积累关于疫苗效力持久性的更多信息。