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
基本信息
- 批准号:10414457
- 负责人:
- 金额:$ 1166.99万
- 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:2021-08-11 至 2021-11-30
- 项目状态:已结题
- 来源:
- 关键词:2019-nCoVAddressAdjuvantAdolescentAdultAncillary StudyBlindedCOVID-19COVID-19 pandemicCOVID-19 vaccineChildhoodDoseEvaluationGoalsHealthIndividualInfectionInvestigationKnowledgeMeasuresNovavax COVID-19 vaccineOutcomeParticipantPhasePlacebosPopulationProteinsProxyRandomizedRecombinantsReverse Transcriptase Polymerase Chain ReactionRiskSARS-CoV-2 infectionSafetySwabTestingVaccinesViral Load resultclinical research siteclinically significantefficacy evaluationimmunogenicitynanoparticlenovel strategiesplacebo controlled studysymptomatologytransmission processvaccine efficacyvaccine trial
项目摘要
Project Summary
The primary goal of current COVID-19 vaccine trials is to measure vaccine efficacy (VE) against clinically
significant infection. However, on a population level, vaccine efficacy against all infection, including
asymptomatic or very mildly symptomatic infection, is an important endpoint. This proposal outlines an ancillary
swab study to the Novavax Phase 3 SARS-CoV-2 vaccine trial (PREVENT-19) to address these knowledge
gaps.
With the global SARS-CoV-2 pandemic, we recognize a significant need for vaccines that not only modify
COVID-19 in SARS-CoV-2 infected individuals but also reduce infection/transmission regardless of
symptomatology. In this study, participants will self-swab twice weekly starting at or shortly after their second
dose of either SARS-CoV-2 rS/M1 or placebo. These swabs will be tested for SARS-CoV-2 by RT-PCR.
Specific Aims of this study are to estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against infection, to
estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against asymptomatic/very mildly symptomatic infection, to
determine the sequence of breakthrough SARS-CoV-2 infections, to estimate the vaccine efficacy on duration
of infection, to estimate the vaccine efficacy against SARS-CoV-2 viral load as a proxy of transmission, and to
explore whether observed vaccine efficacy against COVID-19 illness reflects a transition from symptomatic into
asymptomatic infections versus an absolute reduction in all SARS-CoV-2 infections.
This ancillary swab study will tell us much about the ability of SARS-CoV-2 rS/M1 to reduce infection regardless
of symptomatology. In addition, it will provide important information on the ability of the vaccine to reduce duration
of infection and transmission.
项目摘要
当前COVID-19疫苗试验的主要目标是测量疫苗对临床
严重感染。然而,在人群水平上,疫苗对所有感染的效力,包括
无症状或症状非常轻微的感染是一个重要的终点。该提案概述了一个辅助
诺华3期SARS-CoV-2疫苗试验(PREVENT-19)的拭子研究,以解决这些知识
差距。
随着全球SARS-CoV-2大流行,我们认识到对疫苗的巨大需求,
COVID-19在SARS-CoV-2感染者中的作用,但无论
医学。在这项研究中,参与者将在第二次或第二次之后不久开始每周自我擦拭两次。
剂量的SARS-CoV-2 rS/M1或安慰剂。这些拭子将通过RT-PCR检测SARS-CoV-2。
本研究的具体目的是评估SARS-CoV-2 rS/M1疫苗抗感染的有效性,
评估SARS-CoV-2 rS/M1疫苗对无症状/极轻度症状感染的有效性,
确定突破性SARS-CoV-2感染的顺序,以估计疫苗在持续时间上的效力
的感染,以估计疫苗对SARS-CoV-2病毒载量的有效性作为传播的代理,并
探索观察到的疫苗对COVID-19疾病的有效性是否反映了从症状性转变为
无症状感染与所有SARS-CoV-2感染的绝对减少。
这项辅助拭子研究将告诉我们SARS-CoV-2 rS/M1减少感染的能力,
的医学。此外,它还将提供有关疫苗减少持续时间能力的重要信息
感染和传播。
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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 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:
$ 1166.99万 - 项目类别:
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