Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old

Description

This is a two-stage, randomized, double blind, placebo-controlled Phase 2b study in healthy participants conducted at a single site.

The study will be conducted in two Stages (Stage 1 and Stage 2) and two arms in Stage 1 (Arm 1 and Arm 2).

Stage 1 Stage 1 will be conducted in an outpatient setting and includes the vaccination with the investigational product, ShigETEC, a live, attenuated, oral vaccine (Arm 1) and placebo (Arm 2) and subsequent follow-up.

Stage 2 Stage 2 will include an infectious challenge of selected Stage 1 participants in an inpatient setting (CHIM: Controlled Human Infection Model) in which participants will receive 1 oral dose of Shigella flexneri 2a 2457T and be followed closely for the signs and symptoms of shigellosis.

Stage 2 will start 21 (+5) days after the last dose of vaccine or placebo.