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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，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，旨在评估接种了fluumist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名受试者将被分为两组；每只手臂150美元。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站点累积到接种疫苗的最后日期之间登记。人口将是感染艾滋病毒的儿童和青少年（大于等于5岁，小于等于18岁），接受稳定的HAART治疗方案不超过16周，预计他们的HAART治疗方案不会改变。所有受试者将尽快于2004年9月开始接种流感疫苗（fluumist或Fluzone），最迟于2004年11月19日。受试者将被随机分配到两个研究组：A组接受冷适应减毒流感活疫苗（fluumist）， B组接受灭活疫苗（IAIV, Fluzone）。

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)