PHASE I, DOSE ESCALATION, SAFETY & ENTEROTOXIGENIC E COLI
PHASE I, DOSE ESCALATION, SAFETY & ENTEROTOXIGENIC E COLI
批准号:
6264081
负责人:
DAVID A SACK
金额:
$0.23万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30
关键词:
Escherichia coli antibacterial agents antibody formation attenuated microorganism bacterial antigens bacterial vaccines clinical research clinical trial phase I colony stimulating factor drug administration rate /duration enterotoxins feces analysis genetic strain human subject human therapy evaluation immunity immunization live vaccine oral administration vaccine development
中文摘要
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英文摘要
Hypothesis: That volunteers who receive the new candidate oral vaccines for enterotoxigenic E. coli, strains PTL002 and PTL003, in doses of 5x10(7), 5x10(9) and 5x10(10) per dose will excrete the vaccine strain in their stool, will have no symptoms related to ingesting the strains, and will develop intestinal antibodies to the E. coli colonization factor antigen, CFA II. These attenuated strains of E. coli produce neither heat labile toxin (LT) nor heat stable toxin (ST) but do express CFA II antigen and they have metabolic defects that limit their growth. It is hoped that when they are given orally, they will stimulate protective anti-CFA immunity.
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