TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV-INFECTED CHILDREN

Flumist 在 HIV 感染儿童中的安全性和免疫原性试验

• 批准号: 7376315
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 0.24万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376315
• 关键词: TRIAL; SAFETY; IMMUNOGENICITY; FLUMIST; HIV

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。本研究将评估使用 FluMist TM 免疫的 HIV 感染儿童的安全性、免疫原性和疫苗病毒的脱落情况。其次，该研究将研究安全性、免疫原性和病毒脱落如何随着疫苗接种时和先前免疫抑制的免疫状态而变化。目前的护理标准是使用 IAIV (Fluzone R) 对感染 HIV 的儿童进行免疫接种。为了检查 FluMist TM 的安全性和/或免疫原性是否与 Fluzone R 显着不同，该研究将包含两个组，其中 A 组 (n=150) 接受 FluMist TM，B 组 (n=150) 接受 Fluzone R鉴于 FluMist TM 与 Fluzone R 的总体安全性和严重不良事件发生率预计相似，该研究对 FluMist TM 与 Fluzone R 的比较的统计效力有限。对于 FluMist TM 与 Fluzone R 的比较，当疫苗效果不存在显着分层时，将跨分层汇总数据。然而，由于疫苗效果可能会因阶层而异，因此存在阶层计算以及汇总分析。 A 组和 B 组反应率之间差异的置信区间将通过精确方法分别估计毒性和免疫原性。该研究将招募 300 名受试者。受试者将根据免疫状态分为 3 层。每组将包含 100 名受试者，随机分配，其中 50 名接受 FluMist TM，而其他 50 名接受 Fluzone R。所有受试者都需要在 PACTG 站点的研究开放时间和最后疫苗接种日期（11 月 19 日）之间登记。 2004）因为流感疫苗的性质每年都在变化。