Initial clinical evaluation of attenuated Shigella flexneri 2a live vector expressing enterotoxigenic Escherichia coli antigens, strain CVD 1208S-122.

对表达产肠毒素大肠杆菌抗原(CVD 1208S-122 菌株)的福氏志贺氏菌 2a 活载体进行初步临床评估。

基本信息

  • 批准号:
    10212188
  • 负责人:
  • 金额:
    $ 152.92万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-07-07 至 2024-04-30
  • 项目状态:
    已结题

项目摘要

Project Summary Shigella and enterotoxigenic Escherichia coli (ETEC) represent two important enteric pathogens. There are no vaccines to prevent both Shigella and ETEC. The Center for Vaccine Development's (CVD) mission to develop vaccines that prevent diarrheal disease in the most vulnerable populations has resulted in construction of a prototype Shigella-ETEC vaccine candidate strain, named CVD 1208S-122. Strain CVD 1208S-122 consists of an attenuated ΔguaBA, Δset, Δsen Shigella flexneri 2a strain that has been engineered to express ETEC colonization factor antigen I (CFA/I) and the B and A2 subunits of heat-labile enterotoxin (LThA2B) from genes integrated into the Shigella chromosome. The overall goal of this proposal is to conduct a proof-of-concept, randomized, double-blinded, placebo-controlled, dose-escalation Phase 1 clinical evaluation on a pilot cGMP lot of strain CVD 1208S-122. Each dose of the live, attenuated vaccine will be administered in the inpatient setting (Research Isolation Ward) and reactogenicity will be assessed over 96 hours (4 days) of direct observation. Stool cultures will be performed, vaccine strains will be isolated from stool, and blood and stool specimens will be analyzed for the immunologic responses to vaccination. This clinical trial is designed to be narrowly focused to provide the preliminary assessment of safety, answer whether the strain is stable, and evaluate the immunogenicity to our Shigella-ETEC combination vaccine approach. Aim1. Assess the safety and tolerability of CVD 1208S-122. Aim 2. Measure the excretion pattern, genetic stability, and transmissibility of CVD 1208S-122. Aim 3. Examine the immune response to CVD 1208S-122. These research aims will assessed within the context of a clinical trial to be conducted according to local legal and regulatory requirements, applicable US federal regulations, ICH guidelines, and Good Clinical Practice (GCP) standards. We have a plan for ensuring clinical monitoring, ongoing quality management with quality assurance and quality control activities, external independent safety oversight, and data management.
项目总结

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)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Eileen M. Barry其他文献

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
The 2022 Vaccines Against <em>Shigella</em> and Enterotoxigenic <em>Escherichia coli</em> (VASE) Conference: Summary of abstract-based presentations
  • DOI:
    10.1016/j.vaccine.2023.11.031
  • 发表时间:
    2024-03-07
  • 期刊:
  • 影响因子:
  • 作者:
    Soumalya Banerjee;Eileen M. Barry;Shahida Baqar;A. Louis Bourgeois;Joseph J. Campo;Robert K.M. Choy;Subhra Chakraborty;Allison Clifford;Carolyn Deal;Marcus Estrada;James Fleckenstein;Mateusz Hasso-Agopsowicz;William Hausdorff;Ibrahim Khalil;Nicole Maier;Cynthia Mubanga;James A. Platts-Mills;Chad Porter;Firadausi Qadri;Michelo Simuyandi
  • 通讯作者:
    Michelo Simuyandi
Clinical trials of Shigella vaccines: two steps forward and one step back on a long, hard road
志贺菌疫苗的临床试验:在漫长而艰难的道路上前进两步后退一步
  • DOI:
    10.1038/nrmicro1662
  • 发表时间:
    2007-07-01
  • 期刊:
  • 影响因子:
    103.300
  • 作者:
    Myron M. Levine;Karen L. Kotloff;Eileen M. Barry;Marcela F. Pasetti;Marcelo B. Sztein
  • 通讯作者:
    Marcelo B. Sztein
Genomic, transcriptomic, and phenotypic differences among archetype emShigella flexneri/em strains of serotypes 2a, 3a, and 6
血清型 2a、3a 和 6 的原型 em 福氏志贺氏菌菌株之间的基因组、转录组和表型差异
  • DOI:
    10.1128/msphere.00408-23
  • 发表时间:
    2023-11-28
  • 期刊:
  • 影响因子:
    3.100
  • 作者:
    Caitlin E. Gabor;Tracy H. Hazen;BreOnna C. Delaine-Elias;David A. Rasko;Eileen M. Barry;Vincent B. Young
  • 通讯作者:
    Vincent B. Young

Eileen M. Barry的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('Eileen M. Barry', 18)}}的其他基金

Advanced Development of a Combined Shigella-ETEC Vaccine
志贺氏菌-ETEC 联合疫苗的先进开发
  • 批准号:
    10704845
  • 财政年份:
    2023
  • 资助金额:
    $ 152.92万
  • 项目类别:
Initial clinical evaluation of attenuated Shigella flexneri 2a live vector expressing enterotoxigenic Escherichia coli antigens, strain CVD 1208S-122.
对表达产肠毒素大肠杆菌抗原(CVD 1208S-122 菌株)的福氏志贺氏菌 2a 活载体进行初步临床评估。
  • 批准号:
    10407441
  • 财政年份:
    2020
  • 资助金额:
    $ 152.92万
  • 项目类别:
An Expanded Multivalent Vaccine to Prevent MDR Shigella and ETEC Disease
预防 MDR 志贺氏菌和 ETEC 疾病的扩展多价疫苗
  • 批准号:
    10584477
  • 财政年份:
    2019
  • 资助金额:
    $ 152.92万
  • 项目类别:
An Expanded Multivalent Vaccine to Prevent MDR Shigella and ETEC Disease
预防 MDR 志贺氏菌和 ETEC 疾病的扩展多价疫苗
  • 批准号:
    10364710
  • 财政年份:
    2019
  • 资助金额:
    $ 152.92万
  • 项目类别:
Good Manufacturing Practices Master Cell and Working Cell Banks and GMP Pilot Lot of Prototype Shigella flexneri 2a live vector expressing enterotoxigenic E. coli antigens, CVD 1208S 122
良好生产规范主细胞和工作细胞库以及表达产肠毒素大肠杆菌抗原的福氏志贺氏菌 2a 活载体原型 GMP 中试批次,CVD 1208S 122
  • 批准号:
    9363198
  • 财政年份:
    2017
  • 资助金额:
    $ 152.92万
  • 项目类别:
Modeling Shigella Interaction with Innate Cells in Enteroid Co-Cultures to Inform Vaccine Development
模拟肠类共培养物中志贺氏菌与先天细胞的相互作用,为疫苗开发提供信息
  • 批准号:
    10427393
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
Modeling Shigella Interaction with Innate Cells in Enteroid Co-Cultures to Inform Vaccine Development
模拟肠类共培养物中志贺氏菌与先天细胞的相互作用,为疫苗开发提供信息
  • 批准号:
    10745566
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
Modeling Shigella Interaction with Innate Cells in Enteroid Co-Cultures to Inform Vaccine Development
模拟肠类共培养物中志贺氏菌与先天细胞的相互作用,为疫苗开发提供信息
  • 批准号:
    10190303
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
Correlates of Vaccine-Induced, Tunable-Protection in an Outbred Tularemia Model
远交兔热病模型中疫苗诱导的可调节保护的相关性
  • 批准号:
    9077642
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
Modeling Shigella Interaction with Innate Cells in Enteroid Co-Cultures to Inform Vaccine Development
模拟肠类共培养物中志贺氏菌与先天细胞的相互作用,为疫苗开发提供信息
  • 批准号:
    10686834
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:

相似海外基金

A personalised approach to manage adverse reactions to CFTR modulator therapy in patients with cystic fibrosis
治疗囊性纤维化患者 CFTR 调节剂治疗不良反应的个性化方法
  • 批准号:
    MR/X00094X/1
  • 财政年份:
    2022
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Research Grant
Mechanistic study of sulfa drug-induced severe cutaneous adverse reactions by focusing on HLA-A*11:01
以HLA-A*为重点的磺胺类药物致严重皮肤不良反应机制研究11:01
  • 批准号:
    22K06738
  • 财政年份:
    2022
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
Identifying genetic polymorphisms and elucidating polygenic architecture associated with adverse reactions due to rituximab
识别遗传多态性并阐明与利妥昔单抗不良反应相关的多基因结构
  • 批准号:
    22K15910
  • 财政年份:
    2022
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Grant-in-Aid for Early-Career Scientists
Severe Cutaneous Adverse Reactions Following Outpatient Antibiotic Therapy: A Population-based Study
门诊抗生素治疗后的严重皮肤不良反应:一项基于人群的研究
  • 批准号:
    449379
  • 财政年份:
    2020
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Studentship Programs
Significance of gamma-chain in severe cutaneous adverse reactions
伽马链在严重皮肤不良反应中的意义
  • 批准号:
    19K17779
  • 财政年份:
    2019
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Grant-in-Aid for Early-Career Scientists
Historical sociology of adverse reactions related to vaccination in Japan
日本疫苗接种不良反应的历史社会学
  • 批准号:
    18K00267
  • 财政年份:
    2018
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Grant-in-Aid for Scientific Research (C)
SEARCH (active Surveillance and Evaluation of Adverse Reactions in Canadian Healthcare) & PREVENT (Pharmacogenomics of Adverse Reaction EVEnts National Team)
SEARCH(加拿大医疗保健不良反应的主动监测和评估)
  • 批准号:
    379425
  • 财政年份:
    2018
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Operating Grants
IGF::OT::IGF SBIR Phase II: Topic 338 - Predictive Biomarkers of Adverse Reactions to Prostrate Cancer Radiotherapy
IGF::OT::IGF SBIR II 期:主题 338 - 前列腺癌放射治疗不良反应的预测生物标志物
  • 批准号:
    9576448
  • 财政年份:
    2017
  • 资助金额:
    $ 152.92万
  • 项目类别:
Development of in silico prediction method for idiosyncratic adverse reactions associated with HLA genotypes
与 HLA 基因型相关的特殊不良反应的计算机预测方法的开发
  • 批准号:
    16K15156
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Grant-in-Aid for Challenging Exploratory Research
Characterising the Immune Response to Drugs That Cause Idiosyncratic Adverse Reactions
表征对引起特殊不良反应的药物的免疫反应
  • 批准号:
    367156
  • 财政年份:
    2016
  • 资助金额:
    $ 152.92万
  • 项目类别:
    Studentship Programs
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了