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: 8336140
• 负责人: ADRIANA R MARQUES
• 金额: $ 26.52万
• 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/8336140
• 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; 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 recently completed follow up on the extension substudy, which followed individuals who receive the vaccine under the initial study for an additional 5 years. This substudy enrolled 638 subjects. 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，在美国，带状疱疹（HZ）每年将影响60万至100万人。 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着增加。抗病毒疗法对Hz的急性阶段具有适度的影响。但是，它似乎并不能阻止毛发神经痛，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的发病率和严重程度的增加与年龄相关的细胞介导的免疫力对Varicella-Zoster病毒（VZV）的免疫力下降之间存在紧密的时间关系。对老年人的活死毒菌疫苗的给药导致VZV特异性细胞介导的免疫的显着且持久的增加。我们假设通过增强VZV特异性细胞免疫反应，可以减少Hz及其并发症的发生率和严重性。 该主要临床研究名为The Shingles预防研究（SPS），由退伍军人事务部（VA）领导，并与Niaid and Merck＆Co.，Inc.进行。该全国试验在5 1/2年期间的22个研究地点进行，并总共招募了38,546名志愿者。在这些人中，在NIH临床中心接种了1,741人。 该疫苗使木瓦的发生率降低了51％：安慰剂组中发生了642例带状疱疹病例，而接种疫苗的组中只有315例。在所有疫苗接收者中，由于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，带状疫苗的疫苗可将慢性神经疼痛的形式降低，这是慢性神经疼痛的形式，这是带状疱疹最常见的严重并发症与安慰剂相比，三分之二。疫苗的耐受性很好，严重不良事件的速率低，疫苗接种部位的局部反应通常很温和。 描述发现的手稿于2005年6月在《新英格兰医学杂志》上发表。FDA批准了Zostavax在2006年5月26日及60岁以上的个人中预防疱疹Zoster，并于2006年5月26日及以上，并建议由60岁及以上的人（ACIP）咨询委员会在10月26日的疱疹预防FDA，以预防疱疹，以预防Zostrax。个人在2011年3月24日以上的50岁以上。 我们最近完成了对扩展子的后续行动，后者遵循了在初次研究中接受疫苗的个人额外的5年。这个物质招募了638名受试者。该物质的目的是获得有关Zostavax在同一队列中长期疗效的其他信息。正在进行结果的分析。