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

PHASE2RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

May 23, 2027

Study Completion Date

May 23, 2027

Conditions
Shigella
Interventions
BIOLOGICAL

ShigETEC 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)

OTHER

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.

BIOLOGICAL

Challenge: 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.

Trial Locations (1)

21205

RECRUITING

Center for Immunization Research, Baltimore

Sponsors
All Listed Sponsors
lead

Eveliqure Biotechnologies GmbH

INDUSTRY

NCT07049159 - 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 | Biotech Hunter | Biotech Hunter