NCT03576183

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Enterotoxigenic Escherichia Coli Infection
• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	VLA1701	VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
BIOLOGICAL	Placebo	buffer component of VLA1701
OTHER	Challenge Strain	LSN03-016011/A

Timeline

• Start date: 2018-06-04
• Primary completion: 2018-06-26
• Completion: 2018-11-30
• First posted: 2018-07-03
• Last updated: 2021-04-23
• Results posted: 2021-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study