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

FLUMIST 在 HIV INF 儿童中的安全性和免疫原性的随机试验

• 批准号: 7606258
• 负责人: Stephen I. Pelton
• 金额: $ 0.22万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606258
• 关键词: Adolescent; Age-Years; Attenuated; Child; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Flushield; Fluzone; Funding; Goals; Grant; Highly Active Antiretroviral Therapy; Immune; Influenza vaccination; Institution; Label; Life; Nature; Phase; Population; Randomized; Randomized Controlled Clinical Trials; Research; Research Design; Research Personnel; Resources; Safety; Site; Source; Time; Time Study; Treatment Protocols; United States National Institutes of Health; Upper arm; Vaccination; Vaccines; Virus; Week; immunogenicity; influenza virus vaccine

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

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 PACTG P1057是一项I/II期随机，开放标签研究，旨在评估HIV感染的儿童和青少年在用Flumist免疫的HIV感染儿童和青少年中疫苗菌株病毒的安全性，免疫原性和脱落。另一个目标是确定安全性，免疫原性和脱落是否随疫苗接种时先前的免疫缺陷和免疫状态而变化。 300名受试者将被招募为2个武器；每只手臂150。由于流感疫苗的性质变化，在研究在PACTG站点开始应计的时间与触觉场所的应计和疫苗接种的最后日期之间，所有受试者都需要入学。稳定的HAART方案的人群将是艾滋病毒感染的儿童和青少年（大于5年，小于18岁），持续不到16周，而他们的Haart方案预计不会改变。所有受试者将在2004年9月开始尽快接受流感免疫（Flumist或Fluzone），直到2004年11月19日。 - ARM A将接收冷适应的活体流感疫苗（Flumist） - ARM B将接收灭活的流感疫苗（IAIV，Fluzone） PACTG P1057 V1.0