RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF 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. PACTG P1057 is a Phase I/II randomized, open label study designed to evaluate the safety, immunogenicity, and shedding of vaccine strain virus in HIV-infected children and adolescents immunized with FluMist. An additional goal is to determine if safety, immunogenicity, and shedding varies as a function of prior immune deficits and immune status at the time of vaccination. 300 subjects will be enrolled into 2 arms; 150 per arm. All subjects need to be enrolled between the time the study opens to accrual at PACTG sites and the last date for vaccination because of the changing nature of the influenza vaccine from year to year. Population will be HIV-infected children and adolescents (greater than equal to 5, less than equal to 18 years of age) on a stable HAART regimen for less than equal to 16 weeks, with no change in their HAART regimen anticipated. All subjects will receive influenza immunization (either FluMist or Fluzone) 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)