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

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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.