Supplementary funding to support the extension of the EDCTP-funded ETEC Vaccine Efficacy study
Supplementary funding to support the extension of the EDCTP-funded ETEC Vaccine Efficacy study
批准号:
MC_PC_23002
负责人:
金额:
$26.47万
依托单位国家:
英国
项目类别:
Intramural
财政年份:
2023
资助国家:
英国
项目状态:
未结题
起止时间:
2023 至 --
中文摘要
Björn Sjöstrand先生(瑞典斯堪的纳维亚Biophma Holding AB)主持的“支持扩展EDCTP资助的试验的补充资金”“非洲幼儿和儿童口服全细胞ETEC候选疫苗的现场研究:评估疗效并为关键阶段试验(ETEC疫苗效力)设定参数”。由于新冠肺炎疫情的负面影响,研究被推迟。ETVAX®是一种针对ETEC的全细胞口服灭活疫苗。ETVAX®通过阻止ETEC细菌附着在小肠细胞上并干扰ETEC毒素对这些细胞的影响来产生免疫力。科学家认为ETVAX是临床上最先进的ETEC疫苗。第一阶段研究的结果支持ETVAX®在赞比亚成人和儿童中的安全性、耐受性和免疫原性。Https://scandinavianbiopharma.se/studies/study-oev-124-phase-i-descending-age-study-in-a-lmic/和https://scandinavianbiopharma.se/studies/oev-128-phase-iib-study-in-children-6-18-months-in-a-lmic/“
英文摘要
"Supplementary funding to support the extension of the EDCTP-funded trial ""Field studies of an oral whole cell ETEC vaccine candidate in African toddlers and children: Assess efficacy and set parameters for pivotal Phase 3 trials (ETEC Vaccine Efficacy)"" held by Mr Björn Sjöstrand (Scandinavian Biopharma Holding AB, Sweden). Study delayed due to the negative impacts of the Covid-19 pandemic. ETVAX® is a killed whole-cell oral vaccine against ETEC. ETVAX® produces immunity by preventing ETEC bacteria from adhering to cells of the small intestine and interfering with the effects of ETEC toxins on these cells. Scientists recognize ETVAX as the most clinically advanced ETEC vaccine. The results of the Phase 1 study support the safety, tolerability, and immunogenicity of ETVAX® in adults and children in Zambia. https://scandinavianbiopharma.se/studies/study-oev-124-phase-i-descending-age-study-in-a-lmic/ and https://scandinavianbiopharma.se/studies/oev-128-phase-iib-study-in-children-6-18-months-in-a-lmic/"
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