THE EFFECTIVENESS OF VACCINES IN CLINICAL PRACTICE

疫苗在临床实践中的有效性

• 批准号: 6024135
• 负责人: EUGENE David SHAPIRO
• 金额: $ 10.38万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6024135
• 关键词: Lyme disease; clinical research; disease /disorder prevention /control; disease /therapy duration; drug screening /evaluation; human subject; human therapy evaluation; outcomes research; pharmacokinetics; vaccines

The goals of Dr. Eugene Shapiro, the principal investigator, are: 1) to conduct high quality research to answer important questions about a) the effectiveness of licensed vaccines as they are used in clinical practice and b) the clinical epidemiology and outcomes of patients with Lyme disease, and 2) to mentor young physicians so that they can become successful independent investigators. Dr. Shapiro completed separate fellowships in pediatric infectious diseases and in clinical epidemiology and research methods. He has been on the faculty at the Yale School of Medicine since 1983. During that time he has developed a large network of collaborators at the university, in the community, and throughout the state for his patient-oriented research projects; he also collaborates with the Connecticut Sate Department of Public Health. Because many important questions about vaccines (e.g., the duration of protection or the vaccine's efficacy in subgroups of patients or for specific manifestations of an infection) cannot be answered by randomized clinical trials, Dr. Shapiro has been especially interested in observational (case-control) studies of the efficacy of licensed vaccines. He is particularly well-known for developing methods (and incorporating them into his studies) to minimize bias and to assess the validity of the results of the large-scale case-control studies that he has conducted of the effectiveness of vaccines in clinical practice. If this proposal is funded, it will allow Dr. Shapiro to spend 75% of his time conducting research and serving as a mentor. Dr. Shapiro is currently conducting a case-control study of the clinical effectiveness of varicella vaccine in children. In future years he plans to conduct a case- control study of the effectiveness of the recently-licensed Lyme vaccine and, eventually, a case-control study of the effectiveness of conjugate pneumococcal vaccine (which is expected to be licensed within the next 12-24 months) in children. Dr. Shapiro is also conducting studies of the long-term outcomes of children and adults who were diagnosed as having Lyme disease from 1 to 15 years ago. Dr. Shapiro will serve as a mentor for 1-2 fellows (or young faculty members) each year. The fellows will learn to conduct high-quality clinical studies by working with Clinical Epidemiology Unit. They also will participate in regular research conferences and journal clubs and will meet regularly with Dr. Shapiro to review their progress and to help them develop their own studies as well as to develop strategies for the development of their careers.

主要研究者尤金·夏皮罗博士的目标是：1）进行高质量的研究，以回答有关a）许可疫苗在临床实践中使用的有效性和B）莱姆病患者的临床流行病学和结局的重要问题，2）指导年轻医生，使他们能够成为成功的独立研究者。夏皮罗博士完成了儿科传染病和临床流行病学和研究方法的单独研究金。自1983年以来，他一直在耶鲁大学医学院任教。在此期间，他在大学，社区和整个州建立了一个庞大的合作者网络，用于他以患者为导向的研究项目;他还与康涅狄格州公共卫生部合作。因为许多关于疫苗的重要问题（例如，尽管随机临床试验无法回答这些问题（如保护期或疫苗在亚组患者中的有效性或针对感染的特定表现），但Shapiro博士一直对许可疫苗有效性的观察性（病例对照）研究特别感兴趣。他尤其以开发方法（并将其纳入他的研究）来最大限度地减少偏倚和评估他在临床实践中进行的疫苗有效性的大规模病例对照研究结果的有效性而闻名。如果这项提案得到资助，它将允许夏皮罗博士花75%的时间进行研究和担任导师。夏皮罗博士目前正在进行一项关于水痘疫苗在儿童中的临床有效性的病例对照研究。在未来几年，他计划对最近获得许可的莱姆病疫苗的有效性进行病例对照研究，并最终对结合肺炎球菌疫苗（预计将在未来12-24个月内获得许可）在儿童中的有效性进行病例对照研究。夏皮罗博士还对1至15年前被诊断患有莱姆病的儿童和成人的长期结果进行了研究。夏皮罗博士每年将担任1-2名研究员（或年轻教职员工）的导师。研究员将学习通过与临床流行病学单位合作进行高质量的临床研究。他们还将参加定期的研究会议和期刊俱乐部，并将定期与夏皮罗博士会面，以审查他们的进展，并帮助他们发展自己的研究，以及为他们的职业发展制定战略。