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

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 摘要 FDA最近批准了四价脑膜炎球菌结合疫苗(MCV4)，考虑到青春期期间脑膜炎球菌疾病风险的增加，建议在青春期前探视时为11-12岁的人、进入高中(约15岁)的人和住在宿舍的大学新生接种疫苗。由于大多数患有围产期获得性艾滋病毒感染的儿童已经进入青春期，而美国大多数新的儿童艾滋病毒感染发生在青少年年龄组，针对脑膜炎球菌免疫接种患者的新的基于年龄的建议将导致大多数艾滋病毒感染青年有资格接种疫苗，而艾滋病毒感染人群没有获得安全性或免疫原性数据。这项I/II期研究将评估MCV-4疫苗在296名感染艾滋病毒的青年中的安全性和免疫原性(年龄在11至15岁之间)；评估MCV4疫苗在感染HIV-1的青年中的长期免疫原性(72周)；评估MCV4疫苗在感染HIV-1的青年中的安全性，包括接种疫苗后的短期局部和全身反应。

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.