VTEU Supplement
VTEU 补充
基本信息
- 批准号:10303002
- 负责人:
- 金额:$ 518万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-02-08 至 2021-11-30
- 项目状态:已结题
- 来源:
- 关键词:AcademiaAddressAfricaAmbulatory Care FacilitiesAreaAwardBiological Response Modifier TherapyCOVID-19ClinicClinicalClinical ProtocolsClinical ResearchClinical TrialsCollaborationsCommunicable DiseasesCommunitiesConduct Clinical TrialsConsultationsContractsCountryDevicesDiagnosisDiagnosticDiseaseDisease OutbreaksEbolaEmerging Communicable DiseasesEnrollmentEnteralEpidemicEquipmentEvaluationFormulationFundingGoalsGovernmentGuidelinesHealthHospitalizationHumanHuman ResourcesImmune responseIndustryInfectionInfluenzaInternationalInterventionInvestigationLaboratoriesLawsLeadershipMalariaMarylandMedical DeviceMentorsMethodsModelingNational Institute of Allergy and Infectious DiseaseNongovernmental OrganizationsOutpatientsParticipantPatientsPersonal SatisfactionPhasePoliciesPopulationPregnant WomenPreventionPrevention trialPreventivePrognostic MarkerProgram DevelopmentProtocols documentationPublic HealthPublishingReagentRegulationReportingResearchResearch PersonnelResearch SubjectsResourcesRespiratory Tract InfectionsRiskSamplingScheduleScientistServicesSexually Transmitted DiseasesSiteSourceSystemSystems BiologyTherapeuticUnited States National Institutes of HealthUniversitiesVaccinesVulnerable PopulationsWorkage groupaging populationbaseclinical research sitedesigndosageenteric pathogenepidemiology studyexperienceglobal healthhealthy volunteerhuman subjectimprovedinnovationmedical schoolsmicrobiotaneglected tropical diseasesnext generationnovelnovel diagnosticsnovel vaccinesorganizational structurepathogenpatient populationpopulation basedpre-clinicalpredictive markerpreventproduct developmentprogramspublic health emergencyresearch studyresponsesample collectionserosurveyskillstargeted deliverytherapeutic vaccinetooltreatment trialvaccine accessvaccine candidatevaccine developmentvaccine evaluation
项目摘要
Project Summary/Abstract
The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health
(CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts
for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics,
therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is
uniquely poised to accomplish this goal. CVD's expert and accomplished investigative team has
complementary skill sets in all areas necessary to address the NIAID priority areas, with established
management plans to effectively allocate work and conduct multiple projects simultaneously. CVD is
internationally recognized for our capacity and capability to conduct controlled human infection trials for
malaria, influenza, and enteric pathogens and to implement treatment and prevention trials in endemic areas
for malaria and neglected tropical diseases (NTD), both of which have been a focus of its research for many
years. CVD has access to U.S. populations of healthy subjects in all age groups for this research and subjects
with special risks, such as patients attending outpatient clinics with sexually transmitted infection (STI) and
other conditions that generally do not requiring hospitalization. Strong domestic collaborations at sites
experienced in clinical trials provide the CVD's VTEU with surge capacity among healthy subjects of all ages
and vulnerable populations such as pregnant women in the U.S. to address public health emergencies. CVD's
international collaborators, including two long-standing permanent field sites in Africa, are an invaluable
resource for vetted international trial sites in low resource countries endemic for malaria and NTD with
experience in conducting high quality NIAID and VTEU studies. This proposal describes mechanisms to
implement protocols that arise from concepts proposed by the Leadership Group (LG) and the research
community including investigators from other VTEUs, academia, industry, non-governmental organizations,
and DMID. These concepts will focus on NIAID priority areas, including malaria, NTD, respiratory infections,
particularly influenza, enteric diseases, STI, and emerging infectious diseases and other infectious disease
considerations. Under our VTEU contract that is nearing completion (2013-2023), CVD was awarded over 23
Task Orders, enrolled over 1,500 participants, and successfully collaborated with national and international
sites. This renewal application is intended to supplement the new VTEU award (1UM1AI148689) that we
received in December, 2019 in response to AI18-046; funding for this award was limited to one year as a result
of an omission by our Sponsored Programs Administration to include a request for 7 full years of funding. The
current proposal seeks to supplement that one year award with an additional 6 years of funding.
项目概要/摘要
马里兰大学医学院 (UMSOM) 疫苗开发和全球健康中心
(CVD) 自 1974 年起就已成为 VTEU 站点。VTEU 的目标是倡导创新概念
用于临床研究并实施评估疫苗、其他预防性生物制品的临床现场协议,
用于治疗和预防传染病和心血管疾病的治疗、诊断和设备
为实现这一目标做好了独特的准备。 CVD 的专家和卓有成效的调查团队
解决 NIAID 优先领域所需的所有领域的互补技能,并已建立
管理层计划有效地分配工作并同时进行多个项目。化学气相沉积是
我们因开展受控人体感染试验的能力而受到国际认可
疟疾、流感和肠道病原体,并在流行地区开展治疗和预防试验
疟疾和被忽视的热带病(NTD),这两者一直是许多人研究的重点
年。 CVD 可以接触到美国所有年龄段的健康受试者来进行这项研究和受试者
有特殊风险的患者,例如患有性传播感染 (STI) 的门诊患者和
其他一般不需要住院的情况。国内现场的强大合作
临床试验经验丰富的CVD的VTEU在各年龄段的健康受试者中具有浪涌能力
以及美国孕妇等弱势群体,以应对突发公共卫生事件。 CVD的
国际合作者,包括非洲的两个长期永久实地基地,是非常宝贵的
为疟疾和被忽视的热带病流行的资源匮乏国家的经过审查的国际试验地点提供资源
进行高质量 NIAID 和 VTEU 研究的经验。该提案描述了以下机制:
实施由领导小组 (LG) 和研究提出的概念产生的协议
社区,包括来自其他 VTEU、学术界、工业界、非政府组织的调查人员,
和DMID。这些概念将重点关注 NIAID 的优先领域,包括疟疾、被忽视的热带疾病、呼吸道感染、
特别是流感、肠道疾病、性传播感染以及新发传染病和其他传染病
考虑因素。根据我们即将完成的 VTEU 合同(2013-2023 年),CVD 获得了超过 23
任务订单,招募了超过 1,500 名参与者,并与国内外成功合作
网站。此续签申请旨在补充我们新授予的 VTEU 奖项 (1UM1AI148689)
2019 年 12 月收到,针对 AI18-046;因此,该奖项的资助期限为一年
我们的赞助计划管理部门遗漏了 7 年的资助请求。这
目前的提案旨在通过额外 6 年的资助来补充一年的资助。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Karen L. Kotloff其他文献
Systems approach to define humoral correlates of immunity to emShigella/em
系统方法来定义对志贺氏菌的免疫体液相关性
- DOI:
10.1016/j.celrep.2022.111216 - 发表时间:
2022-08-16 - 期刊:
- 影响因子:6.900
- 作者:
Biana Bernshtein;Esther Ndungo;Deniz Cizmeci;Peng Xu;Pavol Kováč;Meagan Kelly;Dilara Islam;Edward T. Ryan;Karen L. Kotloff;Marcela F. Pasetti;Galit Alter - 通讯作者:
Galit Alter
Predictive modelling of linear growth faltering among pediatric patients with Diarrhea in Rural Western Kenya: an explainable machine learning approach
- DOI:
10.1186/s12911-024-02779-7 - 发表时间:
2024-12-02 - 期刊:
- 影响因子:3.800
- 作者:
Billy Ogwel;Vincent H. Mzazi;Alex O. Awuor;Caleb Okonji;Raphael O. Anyango;Caren Oreso;John B. Ochieng;Stephen Munga;Dilruba Nasrin;Kirkby D. Tickell;Patricia B. Pavlinac;Karen L. Kotloff;Richard Omore - 通讯作者:
Richard Omore
Characterization of emShigella flexneri/em serotype 6 strains from geographically diverse low- and middle-income countries
来自不同地理区域的中低收入国家的 em 弗氏志贺菌 6 型菌株的特征描述
- DOI:
10.1128/mbio.02210-24 - 发表时间:
2024-11-29 - 期刊:
- 影响因子:4.700
- 作者:
Caitlin E. Gabor;Charlotte E. Chong;Jose M. Lemme-Dumit;Tracy H. Hazen;Kate S. Baker;Karen L. Kotloff;Irene N. Kasumba;Sharon M. Tennant;Henry Badji;M. Jahangir Hossain;Richard Omore;Benjamin Ochieng;Alex O. Awuor;Billy Ogwel;Jane Juma;Eileen M. Barry;David A. Rasko - 通讯作者:
David A. Rasko
Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator
随机、安慰剂对照、双盲 2 期试验,比较单一标准剂量与高剂量 CVD 103-HgR 减毒口服霍乱活疫苗(使用 Shanchol 灭活口服疫苗作为开放标签免疫学)的反应原性和免疫原性
- DOI:
- 发表时间:
2017 - 期刊:
- 影响因子:0
- 作者:
S. Sow;M. Tapia;Wilbur H. Chen;F. Haidara;Karen L. Kotloff;Marcela F. Pasetti;William C. Blackwelder;A. Traoré;Boubou Tamboura;Moussa Doumbia;F. Diallo;F. Coulibaly;Uma Onwuchekwa;Mamoudou Kodio;S. Tennant;M. Reymann;Diana F. Lam;Marc Gurwith;Michael D. Lock;Thomas Yonker;Jonathan Smith;Jakub K. Simon;Myron M Levine - 通讯作者:
Myron M Levine
Epidemiology of human metapneumovirus among children with severe or very severe pneumonia in high pneumonia burden settings: the Pneumonia Etiology Research for Child Health (PERCH) study experience
高肺炎负担环境中患有严重或极严重肺炎儿童中人偏肺病毒的流行病学:儿童健康肺炎病因学研究(PERCH)的经验
- DOI:
10.1016/j.cmi.2024.10.023 - 发表时间:
2025-03-01 - 期刊:
- 影响因子:8.500
- 作者:
Ryo Miyakawa;Haijun Zhang;W. Abdullah Brooks;Christine Prosperi;Henry C. Baggett;Daniel R. Feikin;Laura L. Hammitt;Stephen R.C. Howie;Karen L. Kotloff;Orin S. Levine;Shabir A. Madhi;David R. Murdoch;Katherine L. O'Brien;J. Anthony G. Scott;Donald M. Thea;Martin Antonio;Juliet O. Awori;Charatdao Bunthi;Amanda J. Driscoll;Bernard Ebruke;Maria Deloria Knoll - 通讯作者:
Maria Deloria Knoll
Karen L. Kotloff的其他文献
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{{ truncateString('Karen L. Kotloff', 18)}}的其他基金
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site
实施疫苗和治疗评估单位 (VTEU) 临床基地
- 批准号:
10580873 - 财政年份:2022
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: COVPN 3004 Boost
实施疫苗和治疗评估单位 (VTEU) 临床站点:COVPN 3004 Boost
- 批准号:
10639869 - 财政年份:2022
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site
实施疫苗和治疗评估单位 (VTEU) 临床基地
- 批准号:
10493529 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site
实施疫苗和治疗评估单位 (VTEU) 临床基地
- 批准号:
10395066 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site
实施疫苗和治疗评估单位 (VTEU) 临床基地
- 批准号:
10659359 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site:21-0011
实施疫苗和治疗评估单位 (VTEU) 临床站点:21-0011
- 批准号:
10414457 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: DMID 21-0012 Mix and Match
实施疫苗和治疗评估单位 (VTEU) 临床站点:DMID 21-0012 混合搭配
- 批准号:
10424839 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site: CoVPN 3004
实施疫苗和治疗评估单位 (VTEU) 临床站点:CoVPN 3004
- 批准号:
10410208 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Vaccine Treatment Evaluation Units(VTEU) mRNA-1273-P204 Moderna Pediatric
疫苗治疗评估单位 (VTEU) mRNA-1273-P204 Moderna 儿科
- 批准号:
10397325 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site
实施疫苗和治疗评估单位 (VTEU) 临床基地
- 批准号:
10659362 - 财政年份:2021
- 资助金额:
$ 518万 - 项目类别:
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