Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701

Diarrhea Clinical Trial

Official title: Randomized Double-Blinded Pilot Study Confirming A Human Challenge Model Using LSN03-016011/A Expressing LT And CS17 And Investigating The Safety Of VLA1701 (An Investigational Oral Cholera And ETEC (Enterotoxigenic E Coli) (Vaccine)

Status Completed

Clinical Trial Summary

This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.

Clinical Trial Description

This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A (LT+ (Labile toxin), ST- (Stable toxin), CS17), as well as collect expanded safety and immunogenicity data.

The study will be carried out in two phases:

Vaccination phase: up to 34 subjects will be randomized 1:1 to receive 2 doses of either VLA1701 or placebo orally. The doses will be given 7 days apart and subjects will be followed as an outpatient for safety.

Challenge Phase: 30 Subjects, out of the 34 subjects, will be challenged.

After challenge, subjects will be monitored for diarrhea and other signs/symptoms of enteric illness by daily medical checks, vital sign determinations, grading and weighing of all stools. ;

Related Conditions & MeSH terms

• Diarrhea
• Enterotoxigenic Escherichia Coli Infection
• Escherichia coli Infections

• NCT number: NCT03576183
• Study type: Interventional
• Source: Valneva Austria GmbH
• Status: Completed
• Phase: Phase 2
• Start date: June 4, 2018
• Completion date: November 30, 2018