EveliQure Biotechnologies GmbH

The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months).
The main question[s] it aims to answer are:
* Safety and clinical tolerability of the vaccine
* Immune responses generated by the vaccine In the age-descending dose-escalating study
* Adult participants will be divided into 2 escalating dose cohorts
* Each age group of paediatric participants will be divided into 3 escalating dose cohorts
* Participants in each cohort will receive three doses of vaccine/placebo two weeks apart
* Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose
* Stool samples will be collected for immunological analysis and shedding of vaccine strain
* Blood samples will be collected for immunological analysis

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.
This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.