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
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Shigella
In brief
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. The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.
Key facts
- Study ID
- NCT07049159
- Run by
- Eveliqure Biotechnologies GmbH
- People needed
- 72
- Starts
- 2025-06-30
- Expected to finish
- 2027-05-23
- Last updated by the study team
- 2025-07-08
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
Where it is running
- Center for Immunization Research — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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