Establishment of a Controlled Human Infection Model with a Lyophilized Strain of Shigella sonnei 53G.

ABSTRACT: Controlled human infection models (CHIMs) are useful for vaccine development. To improve on existing models, we developed a CHIM using a lyophilized preparation of Shigella sonnei strain 53G produced using current good manufacturing practice (cGMP). Healthy adults were enrolled in an open-label dose-ranging study. Following administration of a dose of rehydrated S. sonnei strain 53G, subjects were monitored for development of disease. The first cohort received 500 CFU of 53G, and dosing of subsequent cohorts was based on results from the previous cohort. Subjects were administered ciprofloxacin on day 5 and discharged home on day 8. Subjects returned as outpatients for clinical checks and sample collection. Attack rates increased as the dose of S. sonnei was increased. Among those receivin

SUBMITTER: Frenck RW 

PROVIDER: S-EPMC7568646 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature