Immune Tolerance Network
Immune Tolerance Network
批准号:
10331451
负责人:
GERALD T NEPOM
金额:
$125.51万
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-02-01 至 2022-05-31
关键词:
AddressAdoptedAffectAllergic DiseaseAreaAutoimmune DiseasesAutoimmunityCaliforniaClinicalClinical SciencesClinical TrialsClinical assessmentsCommunitiesDevelopmentDiseaseElementsFosteringFreedomFutureGeneral HospitalsGeneticGrantHealthHealth Care CostsHumanHypersensitivityImmune ToleranceImmunologicsImmunologyIndividualIndustryInstitutionInterventionLeadLeadershipLifeMassachusettsNational Institute of Allergy and Infectious DiseaseOrgan failurePopulationProcessQuality of lifeResearch DesignResearch InstituteResearch PersonnelResource SharingRiskRoleSan FranciscoSavingsStandardizationStructureTherapeuticTherapeutic immunosuppressionTransplantationUnited StatesUniversitiesVertebral columnVirginiaburden of illnessclinical research sitedata managementdata sharingdesigndrug withdrawalexperienceflexibilityinnovationnext generationnoveloperationpreclinical studyprogramsresponsetool
中文摘要
项目概要/摘要
BCG可以诱导先天免疫系统的表观遗传变化,具有非特异性记忆特征,
称为“训练免疫”,与对异源感染的增强免疫应答有关,
疫苗。我们假设卡介苗接种诱导的免疫增强将为
高风险个体对抗COVID-19和其他病毒性呼吸道感染。将评估这一假设
通过进行BCG东京的II期双盲、随机、安慰剂(媒介物)对照临床试验,
172-1(BCG-日本)疫苗用于预防医护人员(高危医护人员)的COVID-19
感染日本卡介苗是最有效的卡介苗制剂之一,表现出相对较高的免疫原性。
微生物活力和人类先天免疫激活,并提供强大的保护,防止结核病和多种
脱靶感染本研究将检验以下假设:
高感染风险将增强先天抗病毒免疫力,以降低SARS-CoV-2感染的风险,和/或
COVID-19的严重程度。将随机抽取2,800名符合条件的志愿保健工作者,
分配到安慰剂疫苗接种或BCG-日本,在Brigham & Women's Hospital进行,
4个临床试验机构。将对受试者进行为期两年的监测,评估病毒性疾病,
SARS-CoV-2的血清学和分子监测。一部分科目将使用
一套系统生物学分析,将与临床数据相结合,以深入了解
BCG对与SARS-CoV-2感染和/或COVID发病率或严重程度相关的人体免疫力的影响。整体
这一方面将提供关于BCG如何重塑人类血液和鼻粘膜的信息
可能与SARS-CoV-2感染和/或发病率相关的保护作用
和COVID的严重性。
英文摘要
Project Summary/ Abstract
BCG can induce epigenetic changes in the innate immune system with non-specific memory characteristics,
termed `trained immunity', associated with enhanced immune responses to heterologous infections and
vaccines. We hypothesize that the enhanced immunity induced by BCG vaccination will provide protection for
high-risk individuals against COVID-19 and other viral respiratory infections. This hypothesis will be assessed
by conducting a Phase II double blind, randomized, placebo (vehicle)-controlled clinical trial of BCG Tokyo
172-1 (BCG-Japan) vaccine for the prevention of COVID-19 in healthcare workers (HCWs at high-risk for
infection. BCG-Japan is one of the most potent formulations of BCG vaccine demonstrating relatively high
microbial viability and human innate immune activation, and offering robust protection against TB and multiple
off-target infections. This study will test the hypothesis that administration of BCG-Japan vaccine to HCWs at
high-risk for infection will enhance innate antiviral immunity to reduce the risk for SARS-CoV-2 .infection and/or
severity of COVID-19. Two thousand and eight hundred (2,800) eligible volunteer HCWs will be randomly
assigned to either a placebo vaccination or BCG-Japan, conducted at Brigham & Women's Hospital and up to
four additional clinical sites. Subjects will be monitored for two years with assessments for viral illness and
serological and molecular monitoring for SARS-CoV-2. A subset of subjects will be intensively studied using a
suite of systems biology analyses, which will be integrated with clinical data to gain insight into the impact of
BCG on human immunity in relation to SARS-CoV-2 infection and/or incidence or severity of COVID. Overall
this aspect will provide information regarding how BCG may reshape the human blood and nasal mucosal
compartments in a manner that may correlate with protection against SARS-CoV-2 infection and/or incidence
and severity of COVID.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Immune Tolerance Network
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批准号:10469778
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项目类别:
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资助金额:$322.98万
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财政年份:2021
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负责人:GERALD T NEPOM
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依托单位:
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批准号:10493548
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资助金额:$483.12万
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财政年份:2021
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负责人:GERALD T NEPOM
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Immune Tolerance Network
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批准号:10471497
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项目类别:
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资助金额:$450.0万
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财政年份:2021
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负责人:GERALD T NEPOM
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依托单位:
Immune Tolerance Network
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批准号:10397200
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项目类别:
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资助金额:$1979.33万
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财政年份:2021
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负责人:GERALD T NEPOM
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依托单位:
Immune Tolerance Network
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批准号:10319233
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项目类别:
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资助金额:$230.0万
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财政年份:2020
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负责人:GERALD T NEPOM
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依托单位:
Immune Tolerance Network
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批准号:9221236
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项目类别:
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资助金额:$2944.8万
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财政年份:2014
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负责人:GERALD T NEPOM
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依托单位:
Immune Tolerance Network
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批准号:8634324
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项目类别:
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资助金额:$3033.19万
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财政年份:2014
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负责人:GERALD T NEPOM
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依托单位:
Immune Tolerance Network
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批准号:10116129
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项目类别:
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资助金额:$2955.03万
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财政年份:2014
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负责人:GERALD T NEPOM
-
依托单位:
Checkpoints and Autoimmune Homeostasis in T1D
-
批准号:7686453
-
项目类别:
-
资助金额:$68.9万
-
财政年份:2008
-
负责人:GERALD T NEPOM
-
依托单位:
CD4+ T CELL PROFILES IN IDDM
-
批准号:7468454
-
项目类别:
-
资助金额:$26.01万
-
财政年份:2007
-
负责人:GERALD T NEPOM
-
依托单位:
Checkpoints and Autoimmune homeostasis in T1D
-
批准号:7197629
-
项目类别:
-
资助金额:$133.22万
-
财政年份:2006
-
负责人:GERALD T NEPOM
-
依托单位:
CD4+ T CELL PROFILES IN IDDM
-
批准号:6916758
-
项目类别:
-
资助金额:$25.64万
-
财政年份:2005
-
负责人:GERALD T NEPOM
-
依托单位:
MHC tetramers for epitopes of B anthracis PA
-
批准号:6883234
-
项目类别:
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资助金额:$35.1万
-
财政年份:2004
-
负责人:GERALD T NEPOM
-
依托单位:
MHC tetramers for epitopes of B anthracis PA
-
批准号:6763899
-
项目类别:
-
资助金额:$35.1万
-
财政年份:2004
-
负责人:GERALD T NEPOM
-
依托单位:
Treatment/Type 1 Diabetes/hGAD65 Altered Peptide Ligand
-
批准号:6575447
-
项目类别:
-
资助金额:$42.0万
-
财政年份:2002
-
负责人:GERALD T NEPOM
-
依托单位:
Treatment/Type 1 Diabetes/hGAD65 Altered Peptide Ligand
-
批准号:6665526
-
项目类别:
-
资助金额:$43.88万
-
财政年份:2002
-
负责人:GERALD T NEPOM
-
依托单位:
Checkpoints and Autoimmune Homeostasis in T1D
-
批准号:8331004
-
项目类别:
-
资助金额:$56.38万
-
财政年份:2001
-
负责人:GERALD T NEPOM
-
依托单位:
ALLELE SPECIFIC TRANSCRIPTIONAL CONTROL OF HLA DQ EXPRESSION
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批准号:6564322
-
项目类别:
-
资助金额:$18.0万
-
财政年份:2001
-
负责人:GERALD T NEPOM
-
依托单位:
PEPTIDE-BASED IMMUNOMODULATION OF IDDM
-
批准号:6349093
-
项目类别:
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资助金额:$21.25万
-
财政年份:2000
-
负责人:GERALD T NEPOM
-
依托单位:
PEPTIDE-BASED IMMUNOMODULATION OF IDDM
-
批准号:6201973
-
项目类别:
-
资助金额:$21.25万
-
财政年份:1999
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负责人:GERALD T NEPOM
-
依托单位:
海外基金