NCT02531685View on ClinicalTrials.gov

Phase 1 Study of dmLT ID Vaccination in Healthy Adults

PHASE1CompletedINTERVENTIONAL

Enrollment

100

Participants

Timeline

Start Date

June 2, 2016

Primary Completion Date

May 4, 2020

Study Completion Date

May 4, 2020

Conditions

Gastroenteritis Escherichia Coli

Interventions

OTHER

Placebo

Placebo: 0.9% Sodium Chloride injection.

BIOLOGICAL

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

LT(R192G/L211A), or dmLT is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700mcg of vaccine protein in a 3 ml, multi-dose.

Trial Locations (1)

45206-1613

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02531685 - Phase 1 Study of dmLT ID Vaccination in Healthy Adults | Biotech Hunter | Biotech Hunter