Development of Robust and Low-cost Vaccines Against Salmonella Paratyphi A
Development of Robust and Low-cost Vaccines Against Salmonella Paratyphi A
批准号:
10704819
负责人:
Rocio Canals Alvarez
金额:
$81.0万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-15 至 2028-08-31
关键词:
5 year oldAdvanced DevelopmentAffinityAfricaAnimal ModelAntibodiesAntigensAsiaBiologicalCause of DeathCessation of lifeClassificationClinical ResearchClinical TrialsDataDevelopmentDoseEffectivenessEnteralFeverFormulationFundingFutureGlycoconjugatesGoalsGood Manufacturing ProcessGram-Negative BacteriaGrantHealthHigh PrevalenceHumanImmune responseIndividualInfectionInvestigational DrugsLeadLicensingLifeMeasuresMembraneModelingMusOryctolagus cuniculusParatyphoid FeverPharmaceutical PreparationsPhaseProcessProductionSafetySalmonellaSalmonella VaccinesSalmonella entericaSalmonella paratyphiSalmonella typhiSalmonella typhimuriumSamplingSeriesStructureTechnologyTestingToxic effectToxicologyVaccinesVesicleWorkbactericidecostcross reacting material 197diarrheal diseaseenteric infectionexperimental studyfoodborne illnessgastrointestinalglobal healthgood laboratory practiceimmunogenicityimprovedlow and middle-income countriesmanufacturemanufacturing processphase 1 studypre-clinicalpreclinical evaluationpreclinical studypreventresearch clinical testingscale upvaccine candidatevaccine safety
中文摘要
点击翻译按钮获取中文摘要
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
海外基金