The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 26, 2018

Primary Completion Date

November 13, 2018

Study Completion Date

February 28, 2019

Conditions
Diarrhea
Interventions
BIOLOGICAL

E. coli strain E1392-75-2A dose 1E10 CFU

Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain

BIOLOGICAL

E. coli strain E1392-75-2A dose 1E9 CFU

Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain

BIOLOGICAL

E. coli strain E1392-75-2A dose 1E8 CFU

Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain

BIOLOGICAL

E. coli strain E1392-75-2A dose 1E7 CFU

Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat

BIOLOGICAL

E. coli strain E1392-75-2A dose 1E6 CFU

Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat

Trial Locations (1)

6718ZB

NIZO Food Research, Ede

All Listed Sponsors
collaborator

FrieslandCampina

INDUSTRY

lead

NIZO Food Research

OTHER

NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection | Biotech Hunter | Biotech Hunter