泰国志贺氏菌肠炎人体挑战模型的建立。
Establishment of a Shigella sonnei human challenge model in Thailand.
机构信息
Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences, Thailand.
出版信息
Vaccine. 2012 Nov 19;30(49):7040-5. doi: 10.1016/j.vaccine.2012.09.061. Epub 2012 Oct 12.
Abstract
In order to establish a human challenge model of Shigella related disease for vaccine testing, a dose-escalating inpatient trial was performed. Three groups of 12 healthy adult volunteers were orally challenged with 93,440 and 1680 CFU of Shigella sonnei strain 53G. Subjects were admitted to the Vaccine Trial Centre (VTC) at Mahidol University in Bangkok, Thailand. The primary purpose of this study was to identify the dose of S. sonnei 53G required to elicit clinical disease in at least 70% of Thai adult subjects. At the highest dose of 1680 CFU, the attack rate was 75%, while at the two lower doses, the attack rate was approximately 50%. This human challenge model, which is the first of its kind in an endemic region, will provide an opportunity for S. sonnei vaccine evaluation in endemic populations.
摘要
为了建立用于疫苗测试的志贺氏菌相关疾病人体挑战模型，进行了一项剂量递增的住院试验。三组 12 名健康成年志愿者口服了 93440、1680 CFU 的宋内志贺氏菌 53G 菌株。受试者被收治在泰国曼谷玛希隆大学疫苗试验中心（VTC）。本研究的主要目的是确定足以引起至少 70%泰国成年受试者出现临床疾病的宋内志贺氏菌 53G 剂量。在最高剂量 1680 CFU 时，攻击率为 75%，而在两个较低剂量时，攻击率约为 50%。这种在流行地区首次进行的人体挑战模型将为流行人群中的宋内志贺氏菌疫苗评估提供机会。
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