TRIAL OF THE 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。这项研究将评估疫苗病毒在接受FluMist TM免疫的HIV感染儿童中的安全性、免疫原性和脱落。其次，这项研究将检查安全性、免疫原性和病毒脱落如何随着接种疫苗时的免疫状态和先前的免疫抑制而变化。目前的护理标准是为感染艾滋病毒的儿童接种IAIV(福音区R)疫苗。为了检验FluMist TM与Fluzone R的安全性和/或免疫原性是否有显著不同，该研究将包括两个组，A组(n=150)接受FluMist TM治疗，B组(n=150)接受Fluzone R治疗。鉴于在总体安全性和严重不良事件发生率方面预期它们将相似，因此这项研究在比较FluMist TM和Fluzone R方面的统计能力有限。对于FluMist TM与Fluzone R的比较，当没有受疫苗影响的显著地层时，数据将跨地层汇集。然而，由于疫苗效果有可能在不同的地层之间有所不同，因此对不同地层的疫苗进行了计算，并进行了汇集分析。对于毒性和免疫原性，将分别估计手臂A和B的反应率差异附近的可信区间，具体方法是。这项研究将吸引300名受试者。受试者将根据免疫状况分为三个层次。每组将包含100名受试者，其中50人接受FluMist TM治疗，另50人接受Fluzone R治疗。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时到最后一次接种疫苗的时间(2004年11月19日)之间登记。

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. This study will evaluate the safety, immunogenicity, and shedding of vaccine virus in HIV-infected children immunized with FluMist TM. Secondarily, the study will examine how safety, immunogenity, and viral shedding vary as a function of immune status at the time of vaccination and with prior immune suppression. The current standard of care is to immunize HIV-infected children with IAIV (Fluzone R). In order to examine whether the safety and/or immunogenicity of FluMist TM differs significantly from that of Fluzone R the study will contain two arms, with Arm A (n=150) receiving FluMist TM and Arm B (n=150) receiving Fluzone R. The study will have limited statistical power for FluMist TM versus Fluzone R comparisons, given that they are expected to be similar with respect to overall safety and the rate of serious adverse events. For FluMist TM versus Fluzone R comparisons, data will be pooled across strata when there are no significant strata by vaccine effects. However, since there is a possibility that vaccine effects will vary across strata, calculations are present for with strata, as well as pooled analyses. The confidence interval around the difference between the response rates of arms A and B will be estimated separately for toxicity and immunogenicity be exact methods. The study will accrue 300 subjects. Subjects will be stratified on the basis of immunologic status into 3 strata. Each Group will contain 100 subjects, randomized such that 50 recieve FluMist TM, while the other 50 receive Fluzone R. All subjects need to be enrolled between the time the study opens to accrual at PACTG sites and the last date of vaccination (November 19, 2004) because of the changing nature of the influenza vaccines from year to year.