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产肠毒素性大肠杆菌(ETEC)是发展中国家青少年细菌性腹泻的主要原因.埃及是ETEC腹泻的流行区.本研究在埃及人群中评价了由ETEC全菌体和重组霍乱毒素B亚单位(rCTB)组成的口服ETEC灭活菌苗的安全性和免疫原性.74名来自埃及本哈两所卫生服务机构的健康成人被随机分组后,分别服用两剂ETEC/rCTB菌苗(E003)或安慰剂.每剂ETEC/rCTB菌苗(4ml)含1.0mg rCTB和～2×10~(10)福马林灭活的ETEC,并洗去SBL101和SBL105株所有耐热肠毒素(ST)活性;每剂安慰剂(4ml)含～1×10~(11)加热灭活的大肠杆菌K-12.两剂的间隔时间为两周,服用前后至少禁食90分钟.服用前向菌苗制剂中加入150ml碳酸氢钠(4g)-柠檬酸缓冲液(1.45g).
Enterotoxigenic Escherichia coli (ETEC) is a major cause of bacterial diarrhea in adolescents in developing countries.Egypt is a endemic area for ETEC diarrhea.This study evaluated in the Egyptian population a combination of ETEC whole cell and recombinant cholera toxin B subunit ( rCTB) .A total of 74 healthy adults from two health facilities in Benha, Egypt, were randomly assigned to receive two doses of the ETEC / rCTB vaccine (E003) or Placebo Each dose of ETEC / rCTB vaccine (4 ml) contained 1.0 mg of rCTB and ~ 2 x 10-10 fumalin inactivated ETEC and washes away all heat-stable enterotoxin (ST) activity of SBL101 and SBL105 strains ; Each placebo (4ml) containing ~ 1 × 10 ~ (11) heat inactivated E. coli K-12 interval between two doses of two weeks before and after fasting for at least 90 minutes before taking the vaccine preparation Was added 150 ml sodium bicarbonate (4 g) - citrate buffer (1.45 g).