NCT02052934 - Safety of Sublingual dmLT for ETEC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 10, 2014

Primary Completion Date

November 2, 2016

Study Completion Date

November 2, 2016

Conditions

Gastroenteritis Escherichia Coli

Interventions

BIOLOGICAL

Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5 cohorts receive 3 doses ranging from 1 mcg to 50 mcg.

BIOLOGICAL

Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5b cohort receive 3 doses of 25 mcg.

Trial Locations (1)

45229-3026

Cincinnati Children's Hospital Medical Center - Gastroenterology, Hepatology and Nutrition, Cincinnati

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH