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首页> 外文期刊>The Journal of Infectious Diseases >Development of Pathogenicity-Driven Definitions of Outcomes for a Field Trial of a Killed Oral Vaccine against Enterotoxigenic Escherichia coli in Egypt: Application of an Evidence-Based Method.
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Development of Pathogenicity-Driven Definitions of Outcomes for a Field Trial of a Killed Oral Vaccine against Enterotoxigenic Escherichia coli in Egypt: Application of an Evidence-Based Method.

机译：埃及针对肠毒素的大肠埃希菌的口服杀伤疫苗现场试验结果的病原性驱动定义的发展：基于证据的方法的应用。

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Background. To design an efficacy trial of a killed oral vaccine against enterotoxigenic Escherichia coli (ETEC) diarrhea in Egyptian children, we derived for ETEC diarrhea an empirical definition that increased the probability that diarrhea associated with excretion of ETEC was caused by the detected ETEC.Methods. We conducted a cohort study of 397 Egyptian children <24 months old and monitored them until they were 3 years old. Vaccine-preventable (VP) ETEC was defined as ETEC expressing >/=1 of the toxin- (heat-labile [LT] toxin) and colonization-factor antigens (CFA I, II, and IV) in the vaccine.Results. Although fecal excretion of VP-ETEC was highly associated with diarrhea, excretion of LT-ETEC per se was not related to diarrhea (adjusted odds ratio [OR(A)], 1.16 [95% confidence interval {CI}, 0.90-1.49]). The fecal excretion of antigenic types of VP-ETEC other than LT-ETEC (non-LT VP-ETEC) was highly associated with diarrheal symptoms (OR(A), 3.91 [95% CI, 2.78-5.49]; P<.001), and this association was greater for nonbloody than for bloody diarrhea.Conclusions. Because the vaccine had been anticipated to protect primarily against symptomatic ETEC diarrhea, these results indicate that the primary-outcome definition of ETEC diarrhea for the trial should be restricted to nonbloody diarrheal episodes associated with fecal excretion of non-LT VP-ETEC.
机译：背景。为了设计杀死埃及儿童肠毒素性大肠杆菌（ETEC）腹泻的口服疫苗的功效试验，我们为ETEC腹泻得出了经验定义，该定义增加了检测到的ETEC引起与ETEC排泄相关的腹泻的可能性。我们对397个24个月以下的埃及儿童进行了队列研究，并对其进行了监测，直到他们3岁为止。疫苗可预防（VP）的ETEC定义为在疫苗中表达> / = 1的毒素（热不稳定[LT]毒素）和定植因子抗原（CFA I，II和IV）的ETEC。尽管VP-ETEC的粪便排泄与腹泻高度相关，但LT-ETEC本身的排泄与腹泻无关（校正比值比[OR（A）]，1.16 [95％置信区间{CI}，0.90-1.49] ）。除LT-ETEC（非LT VP-ETEC）以外的VP-ETEC抗原类型的粪便排泄与腹泻症状高度相关（OR（A），3.91 [95％CI，2.78-5.49]; P <.001 ），并且这种非血脂的关联性大于血性腹泻的关联性。由于已预期疫苗将主要针对症状性ETEC腹泻提供保护，因此这些结果表明，该试验中ETEC腹泻的主要结果定义应限于与非LT VP-ETEC粪便排泄相关的非血性腹泻发作。

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