Immune Tolerance Network
免疫耐受网络
基本信息
- 批准号:10331451
- 负责人:
- 金额:$ 125.51万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-02-01 至 2022-05-31
- 项目状态:已结题
- 来源:
- 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
项目摘要
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.
项目摘要/摘要
项目成果
期刊论文数量(0)
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会议论文数量(0)
专利数量(0)
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{{ truncateString('GERALD T NEPOM', 18)}}的其他基金
Checkpoints and Autoimmune Homeostasis in T1D
T1D 中的检查点和自身免疫稳态
- 批准号:
7686453 - 财政年份:2008
- 资助金额:
$ 125.51万 - 项目类别:
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