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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 PACTG P1057是一项I/II期随机开放标签研究，旨在评估疫苗株病毒在接受FluMist免疫的HIV感染儿童和青少年中的安全性、免疫原性和脱落。另一个目标是确定安全性、免疫原性和脱落是否随接种疫苗时先前的免疫缺陷和免疫状态而变化。 300名受试者将被分成2组；每组150人。由于流感疫苗的性质每年都在变化，所有受试者都需要在研究开始在PACTG地点应计的时间到最后接种疫苗的日期之间登记。艾滋病毒感染的儿童和青少年(大于等于5岁，小于等于18岁)将接受不到16周的稳定的HAART方案，他们的HAART方案预计不会改变。所有受试者将尽快于2004年9月开始接受流感免疫接种(流感喷雾疫苗或流感地带疫苗)，最迟于2004年11月19日开始。受试者将被随机分配到任一研究组： --ARM A将接种冷适应减毒活疫苗(FluMist) --B组将接种灭活流感疫苗(IAIV、福尔蒙) PACTG P1057 V1.0

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