PACTG P1057: 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. 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.