PACTG P1057: SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV-INFECTED CHILDREN

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。设计：第一阶段/第二阶段，开放标签。样本量：300名受试者，每只手臂150名。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儿科艾滋病临床试验小组(PACTG)站点应计的时间到最后接种疫苗的日期之间登记。人群：感染艾滋病毒的儿童和青少年(=5岁至18岁)接受稳定的高效抗逆转录病毒疗法(HAART)治疗16周，他们的HAART方案预计不会改变。HAART的定义为：来自至少两个不同治疗类别的3种抗逆转录病毒药物(ARV)或ZDV/3TC/ABC(Trizivir？)的组合。*HIV-1血浆RNA在筛查前60天内拷贝数为60,000份/毫升。*CD4+百分比=15%(第1组和第2组)或=25%(第3组)，且CD4+计数符合CDC免疫2级或更好的年龄特定标准。*在过去两年中至少有一年接受过灭活流感疫苗接种。方案：所有受试者将尽快于2004年9月开始接受流感免疫接种，最迟于2004年11月19日开始接种。受试者将被随机分配到任一研究组：*组A将接种感冒适应减毒活疫苗(FluMist)。*B组将接种灭活流感疫苗(IAIV，Fluzone)。分层：两个研究分支中的每一个都将根据以下的CD4%标准进行分层(每组50名受试者)：*第1组=CD4%15%，筛查时15%*第2组=CD4%=15%，筛查时25%*第3组=CD4%25%，筛查最低点25%，定义为受试者有生之年有记录的最低的CD4%。在整个研究过程中，受试者将留在他/她指定的小组中，以便进行分析。治疗/研究持续时间：在第0天进行一次免疫后，受试者将被跟踪6个月。

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. DESIGN: Phase I/II, open label. SAMPLE SIZE: 300 subjects; 150 per arm. All subjects need to be enrolled between the time the study opens to accrual at Pediatric AIDS Clinical Trials Group (PACTG) sites and the last date for vaccination because of the changing nature of the influenza vaccines from year to year. POPULATION: HIV-infected children and adolescents (= 5 to < 18 years of age) on a stable Highly Active Antiretroviral Therapy (HAART) regimen for = 16 weeks, with no change in their HAART regimen anticipated. HAART is defined as = 3 antiretroviral drugs (ARVs) from at least two different therapeutic classes or the combination of ZDV/3TC/ABC (Trizivir¿). * HIV-1 plasma RNA < 60,000 copies/mL within 60 days prior to screening. * CD4+ percentage = 15% (Groups 1 and 2) or = 25% (Group 3) and CD4+ count that meets age-specific criteria for CDC immunological class 2 or better. * Receipt of inactivated influenza vaccine in at least one of the prior two years. REGIMEN: All subjects will receive influenza immunization 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¿). STRATIFICATION: Each of the two study arms will be stratified by the following CD4% criteria (50 subjects per group): * Group 1 = CD4% 15% at nadir and 15% at screening * Group 2 = CD4% = 15% but < 25% at nadir and 15% at screening * Group 3 = CD4% 25% at nadir and 25% at screening Nadir is defined as the lowest CD4% ever recorded during the subject's lifetime. The subject will remain in his/her assigned Group throughout the study for purposes of analysis. TREATMENT/ STUDY DURATION: After a single immunization on Day 0 subjects will be followed for 6 months.