RecruitingPhase 2NCT07049159

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

A Two-stage, Phase 2b, Randomized, Double-blind, Placebo-controlled 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


Sponsor

Eveliqure Biotechnologies GmbH

Enrollment

72 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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. The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral vaccine called ShigETEC designed to protect against two common causes of severe diarrhea: Shigella bacteria and a strain of E. coli called ETEC. This type of diarrhea can be dangerous, especially in travelers and people in areas with limited clean water. **You may be eligible if:** - You are a healthy adult between 18 and 50 years old - You are not pregnant or nursing - You have a BMI between 19 and 40 - You are willing to stay at an inpatient unit for observation during part of the study - You agree to use effective birth control during the study **You may NOT be eligible if:** - You have a history of serious gastrointestinal disease (e.g., inflammatory bowel disease, liver disease) - You have taken antibiotics, probiotics, or antacids within 7 days before the vaccine dose - You have a weakened immune system - You work as a food handler or in direct patient/childcare - You have an immunocompromised person or a child under 2 in your household - You have had a confirmed Shigella or ETEC infection in the past 5 years - You have known allergies to study drug components (including soy or PEG) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALShigETEC vaccine

The ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10\^10 CFU)

OTHERPlacebo

Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.

BIOLOGICALChallenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU

In the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10\^3 CFU.


Locations(1)

Center for Immunization Research

Baltimore, Maryland, United States

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NCT07049159


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