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: 8555844
• 负责人: ADRIANA R MARQUES
• 金额: $ 12.56万
• 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/8555844
• 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; FDA approved; Frequencies; Ganglia; Herpes zoster disease; Herpesvirus Type 3; Immune response; Immunity; Immunization; Incidence; Individual; Journals; Life; Manuscripts; Medicine; Names; National Institute of Allergy and Infectious Disease; Nerve Pain; New England; Pain; Phase; Placebos; Postherpetic neuralgia; Prevention; Publishing; Reaction; Serious Adverse Event; Severities; Site; United States; United States Department of Veterans Affairs; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Vesicular Skin Diseases; Veterans; Virus Diseases; afferent nerve; age related; cohort; cooperative study; follow-up; prevent; programs; research study; 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 shingles by 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 describing 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 26, 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. The FDA approved ZOSTAVAX for prevention of herpes zoster in individuals 50 years of age and older on March 24, 2011. We have completed follow up on the long term extension substudy, which followed individuals who receive the vaccine under the initial study for an additional 5 years. This substudy enrolled 638 subjects at NIH. The aim of this substudy is to accrue additional information on the long-term efficacy of ZOSTAVAX in this same cohort. Analyses of the results are being performed.

据估计，美国每年有 60 万至 100 万人受带状疱疹 (HZ) 影响。带状疱疹的发生率和严重程度及其并发症的频率和严重程度随着年龄的增长而显着增加。抗病毒治疗对带状疱疹急性期影响不大。然而，它似乎并不能预防带状疱疹后神经痛，这是带状疱疹最常见的并发症。在过去的十年中，研究表明，带状疱疹的发病率和严重程度随年龄增加而增加，与细胞介导的水痘带状疱疹病毒 (VZV) 免疫力随年龄增加而下降之间存在密切的时间关系。给老年人注射水痘带状疱疹减毒活疫苗可显着且持久地增强水痘带状疱疹病毒特异性细胞介导的免疫力。我们假设，通过增强水痘带状疱疹病毒特异性细胞免疫反应，可以降低带状疱疹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 和默克公司合作开展。这项全国性试验在 22 个研究中心进行，历时 5 1/2 年，总共招募了 38,546 名志愿者。其中 1,741 人在 NIH 临床中心接种了疫苗。 该疫苗使带状疱疹的发病率降低了 51%：安慰剂组中出现了 642 例带状疱疹，而接种疫苗组中只有 315 例。在所有疫苗接种者中，带状疱疹引起的疼痛和不适总负担比安慰剂接种者低 61%。此外，与安慰剂相比，带状疱疹疫苗将带状疱疹后神经痛（PHN）的发病率降低了三分之二，PHN是一种慢性神经痛，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较低，接种地点的局部反应普遍较轻。 描述研究结果的手稿于 2005 年 6 月发表在《新英格兰医学杂志》上。 FDA 于 2006 年 5 月 26 日批准 ZOSTAVAX 用于预防 60 岁及以上人群的带状疱疹，并于 2006 年 10 月 26 日由免疫实践咨询委员会 (ACIP) 推荐用于预防 60 岁及以上人群的带状疱疹。 FDA 批准 ZOSTAVAX 用于预防 60 岁及以上人群的带状疱疹。 2011 年 3 月 24 日年龄在 50 岁及以上的个人。 我们已经完成了长期延伸亚研究的随访，该研究对在初始研究中接受疫苗的个体进行了另外 5 年的跟踪。这项亚研究在 NIH 招募了 638 名受试者。本亚组研究的目的是获得有关 ZOSTAVAX 在同一队列中长期疗效的更多信息。正在对结果进行分析。