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

Not Applicable

Recruiting

• Conditions: Shigella
• Interventions: Biological: ShigETEC vaccine; Other: Placebo

• Registration Number: NCT07049159
• Lead Sponsor: Eveliqure Biotechnologies GmbH

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Study Start: 2025-06-30
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2027-05-23
• Study Completion: 2027-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ShigETEC, a live, attenuated, oral vaccine	ShigETEC vaccine	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain	Up to study day 60	The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of ShigETEC oral vaccine	Up to 12 months after last vaccination	* Number and severity of gastrointestinal and other solicited symptoms (specified as reactogenicity events) up to Day 16 (6 days after last vaccination); * Number and severity of unsolicited AEs up to Day 60 (28 days after challenge); * Number and severity of SAEs/MAAEs/pIMD up to Day 375 (12 months after last vaccination); * Number and severity of AEs of special interest
Characterization of the challenge strain shedding in stool samples	Up to study day 40	Number and percentage of participants with detectable presence of challenge strain in stool samples detected by quantitative or qualitative culture or polymerase chain reaction (PCR).
Severity of disease following challenge using Shigella disease score	Up to day 40	Maximum disease severity following challenge in the vaccinated vs placebo groups using the Shigella disease score.

Trial Locations

Locations (1)

Center for Immunization Research; 🇺🇸 Baltimore, Maryland, United States