RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN
RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN
批准号:
7606258
负责人:
Stephen I. Pelton
金额:
$0.22万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-01-03 至 2007-11-30
关键词:
AdolescentAge-YearsAttenuatedChildComputer Retrieval of Information on Scientific Projects DatabaseEnrollmentFlushieldFluzoneFundingGoalsGrantHighly Active Antiretroviral TherapyImmuneInfluenza vaccinationInstitutionLabelLifeNaturePhasePopulationRandomizedRandomized Controlled Clinical TrialsResearchResearch DesignResearch PersonnelResourcesSafetySiteSourceTimeTime StudyTreatment ProtocolsUnited States National Institutes of HealthUpper armVaccinationVaccinesVirusWeekimmunogenicityinfluenza virus vaccine
中文摘要
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
PACTG P1057是一项I/II期随机开放标签研究,旨在评估疫苗株病毒在接受FluMist免疫的HIV感染儿童和青少年中的安全性、免疫原性和脱落。另一个目标是确定安全性、免疫原性和脱落是否随接种疫苗时先前的免疫缺陷和免疫状态而变化。
300名受试者将被分成2组;每组150人。由于流感疫苗的性质每年都在变化,所有受试者都需要在研究开始在PACTG地点应计的时间到最后接种疫苗的日期之间登记。艾滋病毒感染的儿童和青少年(大于等于5岁,小于等于18岁)将接受不到16周的稳定的HAART方案,他们的HAART方案预计不会改变。所有受试者将尽快于2004年9月开始接受流感免疫接种(流感喷雾疫苗或流感地带疫苗),最迟于2004年11月19日开始。受试者将被随机分配到任一研究组:
--ARM A将接种冷适应减毒活疫苗(FluMist)
--B组将接种灭活流感疫苗(IAIV、福尔蒙)
PACTG P1057 V1.0
英文摘要
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
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Single Antigen Strategy for Prevention of Recurrent and Chronic Suppurative Otitis
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批准号:9105737
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项目类别:
-
资助金额:$21.75万
-
财政年份:2015
-
负责人:Stephen I. Pelton
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依托单位:
LATE OUTCOMES OF PEDIATRIC HIV INFECTION (PACTG 219C VERSION 40)
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批准号:7606299
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项目类别:
-
资助金额:$11.98万
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财政年份:2007
-
负责人:Stephen I. Pelton
-
依托单位:
SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS
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批准号:7606296
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项目类别:
-
资助金额:$0.43万
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财政年份:2007
-
负责人:Stephen I. Pelton
-
依托单位:
LATE OUTCOMES OF PEDIATRIC HIV INFECTION (PACTG 219C VERSION 40)
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批准号:7379534
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项目类别:
-
资助金额:$14.31万
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财政年份:2005
-
负责人:Stephen I. Pelton
-
依托单位:
ULTRASOUND EVAL OF FLOW RELATED ARTERIAL DILATION IN HIV INFECTED CHILDREN
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批准号:7379489
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项目类别:
-
资助金额:$0.66万
-
财政年份:2005
-
负责人:Stephen I. Pelton
-
依托单位:
IMMUNOGENICITY OF LIVE ATTENUATED VARICELLA VACCINE HIV INFECTED CHILDREN
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批准号:7379533
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项目类别:
-
资助金额:$0.11万
-
财政年份:2005
-
负责人:Stephen I. Pelton
-
依托单位:
RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN
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批准号:7379515
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项目类别:
-
资助金额:$1.31万
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财政年份:2005
-
负责人:Stephen I. Pelton
-
依托单位:
ULTRASOUND EVAL OF FLOW RELATED ARTERIAL DILATION IN HIV INFECTED CHILDREN
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批准号:7206287
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项目类别:
-
资助金额:$1.83万
-
财政年份:2004
-
负责人:Stephen I. Pelton
-
依托单位:
LATE OUTCOMES OF PEDIATRIC HIV INFECTION (PACTG 219C VERSION 40)
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批准号:7206308
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项目类别:
-
资助金额:$9.5万
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财政年份:2004
-
负责人:Stephen I. Pelton
-
依托单位:
RANDOMIZED TRIAL OF THE SAFETY AND IMMUNOGENICITY OF FLUMIST IN HIV INF CHILDREN
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批准号:7206304
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项目类别:
-
资助金额:$1.33万
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财政年份:2004
-
负责人:Stephen I. Pelton
-
依托单位:
IMMUNOGENICITY OF LIVE ATTENUATED VARICELLA VACCINE HIV INFECTED CHILDREN
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批准号:7206307
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项目类别:
-
资助金额:$0.17万
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财政年份:2004
-
负责人:Stephen I. Pelton
-
依托单位:
Immunogenicity of Pneumococcal Conjugate Vaccine
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批准号:7042179
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项目类别:
-
资助金额:$0.54万
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财政年份:2003
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负责人:Stephen I. Pelton
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依托单位:
Late Outcomes of Pediatric HIV Infection (PACTG 219C Version 4.0)
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批准号:7042220
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项目类别:
-
资助金额:$8.32万
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财政年份:2003
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负责人:Stephen I. Pelton
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依托单位:
ACTG 265--IMMUNOGENICITY OF ATTENUATED VARICELLA VACCINE IN HIV+ CHILDREN
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批准号:6306755
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项目类别:
-
资助金额:$3.05万
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财政年份:1999
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负责人:Stephen I. Pelton
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依托单位:
ACTG 219--LATE OUTCOMES OF PEDIATRIC HIV INFECTION
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批准号:6306756
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项目类别:
-
资助金额:$3.05万
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财政年份:1999
-
负责人:Stephen I. Pelton
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依托单位:
ACTG 338--ANTIRETROVIRAL THERAPY IN STABLE EXPERIENCED HIV INFECTED CHILDREN
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批准号:6306745
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项目类别:
-
资助金额:$3.05万
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财政年份:1999
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负责人:Stephen I. Pelton
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依托单位:
ACTG 265--IMMUNOGENICITY OF ATTENUATED VARICELLA VACCINE IN HIV+ CHILDREN
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批准号:6117241
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项目类别:
-
资助金额:$3.05万
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财政年份:1998
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负责人:Stephen I. Pelton
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依托单位:
ACTG 338--ANTIRETROVIRAL THERAPY IN STABLE EXPERIENCED HIV INFECTED CHILDREN
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批准号:6117244
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项目类别:
-
资助金额:$3.05万
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财政年份:1998
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负责人:Stephen I. Pelton
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依托单位:
ACTG 219--LATE OUTCOMES OF PEDIATRIC HIV INFECTION
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批准号:6117224
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项目类别:
-
资助金额:$3.05万
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财政年份:1998
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负责人:Stephen I. Pelton
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依托单位:
AT/AZ AS COMPARED TO TMP/SMX IN PREVENTING BATERIAL INFECTION
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批准号:6117228
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项目类别:
-
资助金额:$3.05万
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财政年份:1998
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负责人:Stephen I. Pelton
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依托单位:
海外基金