Task X14: Evaluation of Ebola Vaccines
Task X14: Evaluation of Ebola Vaccines
批准号:
10787965
负责人:
MARY BRUCE
金额:
$0.63万
依托单位国家:
美国
项目类别:
财政年份:
2015
资助国家:
美国
项目状态:
已结题
起止时间:
2015-09-10 至 2020-07-31
关键词:
AreaBiologicalBiological ProductsBioterrorismClinicalCommunicable DiseasesContractsDevelopmentEbolaEbola VaccinesEducational workshopEmerging Communicable DiseasesEvaluationFeasibility StudiesImmunology procedureInvestigational New Drug ApplicationLicensingOffice of Administrative ManagementQualifyingReportingSafetySamplingServicesSite VisitTestingToxicologyTrainingVaccinesValidationefficacy testingevaluation/testingimmunogenicitynovel vaccinesproduct developmenttesting servicesvaccine candidatevaccine development
中文摘要
传染病疫苗和其他生物制品评估和测试服务(ETS)合同提供从早期可行性研究到提交生物许可证申请(BLA)和/或研究新药(IND)申请所需的各种产品开发服务。任务领域包括:1)行政管理和技术支持,包括培训和讲习班,以及质量监督和管理(现场访问、关键阶段审计和最终研究报告审计),2)免疫分析的开发、鉴定和验证,3)免疫原性和有效性测试,4)非临床和临床样本测试,以及5)安全/毒理学研究。这些服务将促进开发和引入新的候选疫苗和生物制品(由CBER监管),以对抗生物恐怖主义和新出现和重新出现的传染病的潜在病原体。
英文摘要
The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.
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Task X14: Evaluation of Ebola Vaccines
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批准号:9555908
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项目类别:
-
资助金额:$8.93万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X13: Evaluation of an E. coli Vaccine Candidate - Immunogenicity Testing
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批准号:9915405
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项目类别:
-
资助金额:$1.32万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X13: Evaluation of an E. coli Vaccine Candidate - Immunogenicity Testing
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批准号:9430302
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项目类别:
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资助金额:$28.09万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X12: Evaluation of Human Tissue Cross-reactivity of Phase I Clinical Trial Serum Samples
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批准号:9208633
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项目类别:
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资助金额:$10.55万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X14: Evaluation of Ebola Vaccines
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批准号:9151779
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项目类别:
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资助金额:$894.26万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X12: Evaluation of Human Tissue Cross-reactivity of Phase I Clinical Trial Serum Samples
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批准号:9151775
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项目类别:
-
资助金额:$26.86万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
TO X13: Evaluation of an E. coli Vaccine Candidate - Immunogenicity Testing
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批准号:9151778
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项目类别:
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资助金额:$25.57万
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财政年份:2015
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负责人:MARY BRUCE
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依托单位:
Task X9: Development of Standardized Filovirus Immune Assays and Reagents
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批准号:8942746
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项目类别:
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资助金额:$176.18万
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财政年份:2014
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负责人:MARY BRUCE
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依托单位:
Task X9: Development of Standardized Filovirus Immune Assays and Reagents
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批准号:9144161
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项目类别:
-
资助金额:$122.28万
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财政年份:2014
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负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:8947486
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项目类别:
-
资助金额:$30.24万
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财政年份:2013
-
负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing Zika Virus Vaccines
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批准号:9201105
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项目类别:
-
资助金额:$232.82万
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财政年份:2013
-
负责人:MARY BRUCE
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依托单位:
Task X5: Challenge Biodistribution Study for Malaria Vaccines
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批准号:8845038
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项目类别:
-
资助金额:$14.0万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:9004545
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项目类别:
-
资助金额:$55.07万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:8930007
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项目类别:
-
资助金额:$38.01万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:9004547
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项目类别:
-
资助金额:$73.77万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task B01: Validation of the MSD Protective Antigen(PA)-ECL Assay
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批准号:8877301
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项目类别:
-
资助金额:$3.71万
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财政年份:2013
-
负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:9004546
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项目类别:
-
资助金额:$2.9万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task X7: Preparedness for Testing NIAID Priority Vaccines for Infectious Diseases
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批准号:8947490
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项目类别:
-
资助金额:$1.37万
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财政年份:2013
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负责人:MARY BRUCE
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依托单位:
Task 1: Evaluation and Testing Services (ETS) for Vaccines and Other Biologics
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批准号:8854836
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项目类别:
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资助金额:$17.19万
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财政年份:2012
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负责人:MARY BRUCE
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依托单位:
Task 1: Evaluation and Testing Services (ETS) for Vaccines and Other Biologics
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批准号:9071481
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项目类别:
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资助金额:$17.33万
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财政年份:2012
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负责人:MARY BRUCE
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依托单位:
海外基金