CLINICAL TRIAL: IMPAACT 1065 PHASE I/II STUDY OF SAFETY AND IMMUNOGENICITY OF Q

临床试验：Q 的安全性和免疫原性的 IMPAACT 1065 I/II 期研究

• 批准号: 8356683
• 负责人: William Thomas Shearer
• 金额: $ 0.18万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356683
• 关键词: 12 year old; 15 year old; Adolescence; Adolescent; Age; Child; Clinical Research; Clinical Trials; Conjugate Vaccines; Data; Funding; Grant; HIV; HIV Infections; HIV-1; IMPAACT; Immunization; Individual; Lead; Life; National Center for Research Resources; Patients; Phase; Population; Principal Investigator; Reaction; Recommendation; Research; Research Infrastructure; Resources; Safety; Source; United States National Institutes of Health; Vaccinated; Vaccines; Visit; Youth; age group; aged; base; college; cost; disorder risk; high school; immunogenicity; pediatric human immunodeficiency virus infection; safety study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT The recent approval by the FDA of the quadrivalent meningococcal conjugate vaccine (MCV4) has led to a recommendation to vaccinate 11-12 year-old individuals at a pre-adolescent visit, individuals entering high school (approximately 15 years of age) and incoming college freshman living in dormitories, in recognition of the increased meningococcal disease risk during adolescence. As the majority of children with perinatally acquired HIV infection have aged into adolescence, and the majority of new pediatric HIV infections in the US are occurring in the adolescent age group, the new age-based recommendations for meningococcal immunization patients will lead to most HIV-infected youth being age-eligible for a vaccine for which there are no safety or immunogenicity data available from HIV-infected populations. This phase I/II study will evaluate the safety and immunogenicity of MCV-4 in 296 HIV-infected youth between =11 and 15); To estimate the long-term (at 72 weeks) immunogenicity of the MCV4 vaccine in HIV-1 infected youth; To evaluate the safety of the MCV4 vaccine in HIV-1 infected youth, including short-term local and systemic reactions following administration of the vaccine.

该子项目是利用资源的众多研究子项目之一 由 NIH/NCRR 资助的中心拨款提供。子项目的主要支持 并且子项目的主要研究者可能是由其他来源提供的， 包括其他 NIH 来源。 子项目可能列出的总成本 代表子项目使用的中心基础设施的估计数量， NCRR 赠款不直接向子项目或子项目工作人员提供资金。 抽象的 FDA 最近批准了四价脑膜炎球菌结合疫苗 (MCV4)，建议在青春期前就诊的 11-12 岁个体、进入高中（约 15 岁）和即将上大学的个体接种疫苗新生住在宿舍，认识到青春期脑膜炎球菌疾病的风险增加。 由于大多数围产期感染艾滋病毒的儿童已进入青春期，而且美国大多数新发儿科艾滋病毒感染发生在青少年年龄组，因此针对脑膜炎球菌免疫患者的新的基于年龄的建议将导致大多数艾滋病毒感染者受感染的青少年符合接种疫苗的年龄，但尚无艾滋病毒感染人群的安全性或免疫原性数据。 这项 I/II 期研究将评估 MCV-4 在 296 名 11 岁至 15 岁之间感染 HIV 的青少年中的安全性和免疫原性；评估 MCV4 疫苗在 HIV-1 感染青少年中的长期（72 周）免疫原性；评估 MCV4 疫苗在 HIV-1 感染青少年中的安全性，包括接种疫苗后的短期局部和全身反应。