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
NCT07049159
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose. The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Shigella
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Eveliqure Biotechnologies GmbH
- Last updated on ClinicalTrials.gov
- July 8, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Maryland · 1
- Center for Immunization Research · Baltimore, MD
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.