RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 PACTG P1057是一项I/II期、随机、开放标签研究，旨在评价疫苗株病毒在接受FluMist免疫的HIV感染儿童和青少年中的安全性、免疫原性和散毒情况。另一个目的是确定安全性、免疫原性和散毒是否随既往免疫缺陷和接种时免疫状态而变化。 300例受试者将入组2组;每组150例。由于流感疫苗的性质每年都在变化，所有受试者都需要在PACTG研究中心研究开始招募至最后一次接种日期之间入组。人群将是接受稳定HAART方案治疗少于16周的HIV感染儿童和青少年（大于等于5岁，小于等于18岁），预期其HAART方案无变化。所有受试者将于2004年9月尽快开始接受流感疫苗接种（FluMist或Fluzone），最晚至2004年11月19日。受试者将随机分配至任一研究组： --A组将接受冷适应减毒活流感疫苗（FluMist） --B组将接受灭活流感疫苗（IAIV，Fluzone） PACTG P1057 V1.0

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) PACTG P1057 V1.0