Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults

PHASE2RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

February 20, 2026

Study Completion Date

August 20, 2026

Conditions
Escherichia Infection
Interventions
OTHER

B7A (ETEC challenge strain)

A pathogenic strain of ETEC that can cause illness ranging from mild watery diarrhea to severe symptoms. The primary complication associated with an infection from this strain is dehydration.

BIOLOGICAL

CssBA

A CS6 based vaccine against ETEC (Enterotoxigenic Escherichia coli) in preventing moderate-severe diarrhea obtained via purification from a host E. coli expression strain, BL21(DE3), harboring a pET24a (+) plasmid containing the CssBA gene expressing the his-tagged CssBA protein.

BIOLOGICAL

dmLT

An E. coli double mutant heat labile toxin. This genetically attenuated strain is expressed from a plasmid (pLC403) in the E. coli expression strain JM83.

OTHER

Placebo

Placebo

Trial Locations (2)

21201-1509

RECRUITING

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health, Baltimore

45229-3039

RECRUITING

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH