PACTG P1057: SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV-INFECTED 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。设计：I/II期，开放式标签。样本数量：300名受试者；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儿童艾滋病临床试验组（PACTG）的研究开始时和接种疫苗的最后日期之间登记。人群：感染艾滋病毒的儿童和青少年（= 5至< 18岁），接受稳定的高效抗逆转录病毒治疗（HAART）方案16周，预期其HAART方案无变化。HAART定义为至少两种不同治疗类别的3种抗逆转录病毒药物（ARVs）或ZDV/3TC/ABC （Trizivir¿）的组合。*筛查前60天内HIV-1血浆RNA < 60,000拷贝/mL。* CD4+百分比= 15%（第1组和第2组）或= 25%（第3组），CD4+计数符合CDC免疫2级或更高的年龄特异性标准。*在过去两年内至少有一年曾注射灭活流感疫苗。方案：所有受试者将尽快于2004年9月开始接种流感疫苗，最迟于2004年11月19日接种。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活疫苗（fluumist¿）。* B组接种灭活流感疫苗（IAIV, Fluzone¿）。分层：两个研究组将按照以下CD4%标准（每组50名受试者）进行分层：*组1 = CD4%，最低点为15%，筛查时为15% *组2 = CD4%，但最低点< 25%，筛查时为15% *组3 = CD4%，最低点为25%，筛查时为25%，最低点被定义为受试者一生中记录的最低CD4%。在整个研究过程中，受试者将留在他/她指定的小组中进行分析。治疗/研究持续时间：第0天单次免疫后，受试者将被随访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.