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

NCT03576183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-04-23

Study results available
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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.

Conditions

  • Enterotoxigenic Escherichia Coli Infection
  • Diarrhea

Interventions

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

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • Naval Medical Research Center

    collaborator FED

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Christian Taucher, PhD · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2018-06-26
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576183 on ClinicalTrials.gov