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Effectiveness of Varicella Vaccine in Clinical Practice

水痘疫苗在临床实践中的有效性

基本信息

批准号：
7101817
负责人：
EUGENE David SHAPIRO
金额：
$ 39.64万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-08-01 至 2008-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7101817
关键词：
Herpesviridae vaccine adolescence (12-20)age difference chickenpox child (0-11)clinical research communicable disease control cost effectiveness human population study human subject human therapy evaluation immunofluorescence technique medical records patient oriented research polymerase chain reaction vaccine evaluation varicella zoster virus

项目摘要

DESCRIPTION (provided by applicant): Live attenuated varicella vaccine was approved in March, 1995 and has been recommended for routine use in susceptible, healthy persons 12 months of age. In the first four years of this study, we have demonstrated that the effectiveness of varicella vaccine in clinical practice was 85 percent overall and 97 percent against moderate or severe disease. Vaccinees who developed varicella generally had very mild disease. However, there continues to be uncertainty about the long-term effectiveness of the vaccine. The primary purpose of the proposed study is to assess the effect of time since vaccination and of age at the time of vaccination on the effectiveness of varicella vaccine as it is used in actual practice. This will be a continuation of a case-control study in which the cases will be immunocompetent children from 13 months to 18 years of age who develop varicella. The cases will be identified through active surveillance of pediatric practices in Connecticut. A research assistant will visit the home of each potential case subject on the third day of the rash to assess the severity of the illness. In addition, material from the lesions will be tested with the polymerase chain reaction test to confirm the presence of varicella-zoster virus and to determine whether it is wild-type or vaccine-type virus. The controls will be immunocompetent children without a history of varicella who are matched to the cases (2 controls/case) by both age and pediatric practice. The medical records of both the cases and the controls will be reviewed to determine whether the child had received varicella vaccine. The effectiveness of the vaccine will be estimated from the matched odds ratios. The effects on the effectiveness of the vaccine of both age at the time of vaccination and time since vaccination will be assessed by conditional logistic regression. The estimates will be adjusted for possible confounders with the use of conditional logistic regression. In addition, differences in the clinical severity of varicella among vaccinated and unvaccinated cases will be assessed, as will whether the severity of disease among vaccinees is affected by either time since vaccination or age at the time of vaccination. This study will provide important information about the effectiveness of varicella vaccine over time that is critical for assessing the cost-effectiveness of the vaccine and the possible need for booster doses, and will be useful both for educating physicians and for counseling parents about having their children vaccinated.

描述（由申请方提供）：水痘减毒活疫苗于1995年3月获得批准，并被推荐用于12个月龄的易感健康人群的常规使用。在这项研究的前四年，我们已经证明水痘疫苗在临床实践中的有效性总体为85%，对中度或重度疾病的有效性为97%。接种水痘疫苗的人通常病情很轻。然而，疫苗的长期有效性仍然存在不确定性。拟议研究的主要目的是评估接种后的时间和接种时的年龄对水痘疫苗在实际应用中的有效性的影响。这将是一项病例对照研究的继续，该研究的病例将是13个月至18岁的免疫功能正常的水痘患儿。这些病例将通过对康涅狄格州儿科实践的积极监测来确定。研究助理将在皮疹的第三天访问每个潜在病例受试者的家，以评估疾病的严重程度。此外，将使用聚合酶链反应试验检测病变材料，以确认水痘-带状疱疹病毒的存在，并确定其是野生型病毒还是疫苗型病毒。对照组将是无水痘病史的免疫功能正常的儿童，他们与病例（2名对照/病例）在年龄和儿科实践方面匹配。将审查病例和对照组的医疗记录，以确定儿童是否接受过水痘疫苗。将根据匹配的比值比估计疫苗的有效性。将通过条件logistic回归评估接种时年龄和接种后时间对疫苗有效性的影响。将使用条件logistic回归对估计值进行调整，以消除可能的混杂因素。此外，还将评估接种疫苗和未接种疫苗病例之间水痘临床严重程度的差异，以及接种疫苗后的时间或接种疫苗时的年龄是否会影响接种疫苗者的疾病严重程度。这项研究将提供关于水痘疫苗随时间推移的有效性的重要信息，这对于评估疫苗的成本效益和可能需要加强剂量至关重要，并且对于教育医生和咨询父母让他们的孩子接种疫苗都很有用。