RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN

FLUMIST 在 HIV INF 儿童中的安全性和免疫原性的随机试验

• 批准号: 7606258
• 负责人: Stephen I. Pelton
• 金额: $ 0.22万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606258
• 关键词: Adolescent; Age-Years; Attenuated; Child; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Flushield; Fluzone; Funding; Goals; Grant; Highly Active Antiretroviral Therapy; Immune; Influenza vaccination; Institution; Label; Life; Nature; Phase; Population; Randomized; Randomized Controlled Clinical Trials; Research; Research Design; Research Personnel; Resources; Safety; Site; Source; Time; Time Study; Treatment Protocols; United States National Institutes of Health; Upper arm; Vaccination; Vaccines; Virus; Week; immunogenicity; influenza virus vaccine

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG P1057 is a Phase I/II randomized, open label study designed to evaluate the safety, immunogenicity, and shedding of vaccine strain virus in HIV-infected children and adolescents immunized with FluMist. An additional goal is to determine if safety, immunogenicity, and shedding varies as a function of prior immune deficits and immune status at the time of vaccination. 300 subjects will be enrolled into 2 arms; 150 per arm. All subjects need to be enrolled between the time the study opens to accrual at PACTG sites and the last date for vaccination because of the changing nature of the influenza vaccine from year to year. Population will be HIV-infected children and adolescents (greater than equal to 5, less than equal to 18 years of age) on a stable HAART regimen for less than equal to 16 weeks, with no change in their HAART regimen anticipated. All subjects will receive influenza immunization (either FluMist or Fluzone) starting as soon as possible in September 2004 and as late as November 19, 2004. Subjects will be randomly allocated to either study Arm: --Arm A will receive cold-adapted live attenuated influenza vaccine (FluMist) --Arm B will receive inactivated influenza vaccine (IAIV, Fluzone) PACTG P1057 V1.0

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 PACTG P1057 是一项 I/II 期随机、开放标签研究，旨在评估使用 FluMist 免疫的 HIV 感染儿童和青少年疫苗株病毒的安全性、免疫原性和脱落情况。另一个目标是确定安全性、免疫原性和脱落是否随先前的免疫缺陷和接种疫苗时的免疫状态而变化。 300名受试者将被纳入2个组；每臂150。由于流感疫苗的性质每年都在变化，所有受试者都需要在 PACTG 站点的研究开放期间和疫苗接种的最后日期之间进行登记。人群为感染 HIV 的儿童和青少年（大于等于 5 岁，小于等于 18 岁），接受稳定的 HAART 治疗方案不少于 16 周，预计其 HAART 治疗方案不会发生变化。所有受试者将尽快从 2004 年 9 月开始并最迟于 2004 年 11 月 19 日接受流感免疫接种（FluMist 或 Fluzone）。受试者将被随机分配到任一研究组： --A组将接种冷适应减毒流感疫苗（FluMist） --B臂将接种灭活流感疫苗（IAIV、Fluzone） PACTG P1057 V1.0