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Development of Robust and Low-cost Vaccines Against Salmonella Paratyphi A

开发针对甲型副伤寒沙门氏菌的强效且低成本疫苗

基本信息

批准号：
10704819
负责人：
Rocio Canals Alvarez
金额：
$ 81万
依托单位：
GLAXOSMITHKLINE BIOLOGICALS
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-15 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10704819
关键词：
5 year old Advanced Development Affinity Africa Animal Model Antibodies Antigens Asia Biological Cause of Death Cessation of life Classification Clinical Research Clinical Trials Data Development Dose Effectiveness Enteral Fever Formulation Funding Future Glycoconjugates Goals Good Manufacturing Process Gram-Negative Bacteria Grant Health High Prevalence Human Immune response Individual Infection Investigational Drugs Lead Licensing Life Measures Membrane Modeling Mus Oryctolagus cuniculus Paratyphoid Fever Pharmaceutical Preparations Phase Process Production Safety Salmonella Salmonella Vaccines Salmonella enterica Salmonella paratyphi Salmonella typhi Salmonella typhimurium Sampling Series Structure Technology Testing Toxic effect Toxicology Vaccines Vesicle Work bactericide cost cross reacting material 197 diarrheal disease enteric infection experimental study foodborne illness gastrointestinal global health good laboratory practice immunogenicity improved low and middle-income countries manufacture manufacturing process phase 1 study pre-clinical preclinical evaluation preclinical study prevent research clinical testing scale up vaccine candidate vaccine safety

项目摘要

Project Summary / Abstract – Development of Robust and Low-cost Vaccines for Preventing S. Paratyphi A: Salmonella enterica is a Gram-negative bacterium that is a leading cause of foodborne illnesses globally. In fact, Salmonella deaths are the first cause of death within enteric and diarrheal diseases and the second cause of death in under 5-years-old. GSK Vaccines Institute for Global Health (GVGH) is developing two multivalent Pan-Salmonella vaccines based on a versatile platform, Generalized Modules for Membrane Antigens (GMMA). These vaccines target the same S. Paratyphi A antigen, but are based on different technologies, conjugate or GMMA, and are intended to provide protection from paratyphoid fever which causes potentially severe and sometimes life-threatening febrile illness. GVGH will complete three Aims within this grant structure. First, preclinical studies will be conducted to evaluate safety, reactogenicity and immunogenicity. Second, process development work for drug substance and drug product will be completed and manufacturing of both non-GMP and GMP batches will follow. Finally, a series of experiments will evaluate the immunological response in either mouse or rabbit models; the data package will include classification of antibody subclasses, affinity and bactericidal activity to provide a correlation between the quality of antibodies and functionality. The final milestone of this grant is to advance the development of a multivalent vaccine against S. Paratyphi A. This will enable GVGH to make clinical trials possible for the improvement of health for individuals worldwide.

项目摘要/摘要