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

NCT03576183 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VLA1701-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Moderate to Severe Diarrhea

  within 120 hours of challenge with ETEC strain LSN03-016011/A.

  5 days after challenge

Secondary Outcomes (6)

• Disease Severity Score After Challenge With ETEC Strain LSN03-016011/ A

  7 days after challenge

• Percentage of Subjects With Solicited Adverse Events

  7days after each vaccination

• Percentage of Subjects With Any Adverse Events (AE)

  until Month 6

• Number of Subjects With Serious Adverse Events

  until Month 6

• Percentage of Subjects With Any IMP (Investigational Medicinal Product) Related Adverse Events

  up to Visit 4 (day of challenge, 23 days post first vaccination)

Study Arms (2)

VLA1701

ACTIVE COMPARATOR

VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli) The vaccine is administered orally in 2 doses about 1 week apart.

Biological: VLA1701; Other: Challenge Strain

Placebo

PLACEBO COMPARATOR

The buffer component of VLA1701 will be used as Placebo. The vaccine is administered orally in 2 doses about 1 week apart.

Biological: Placebo; Other: Challenge Strain

Interventions

VLA1701 BIOLOGICAL

VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)

VLA1701

Placebo BIOLOGICAL

buffer component of VLA1701

Placebo

Challenge Strain OTHER

LSN03-016011/A

Placebo; VLA1701

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and non-pregnant female subjects aged 18 to \<50 years;
• BMI of 19.0 to 35.0 kg/m2
• Willingness to participate after informed consent has been obtained from the subject prior to any study related procedures.
• Completion of a training session and demonstration of comprehension of the protocol procedures and knowledge of ETEC-associated illness by passing a written examination.
• If subject is of childbearing potential:
• Negative pregnancy test at screening with understanding to not become pregnant within 28 days after challenge;
• Subject has practiced an effective method of contraception during the 30 days before screening (Visit 0);
• Subject agrees to employ adequate birth control measures for the duration of the study.

You may not qualify if:

• Participated in research involving investigational product within 30 days before planned date of first vaccination or planned use through Day 44;
• Any prior exposure to ETEC (including LSN03-016011/A) or cholera occupationally or received LT (Or any mutant forms of LT (e.g., LTR192G, LTR192GL211A), ETEC, or cholera vaccine);
• Subjects with known abnormal stooling patterns (fewer than 3 per week or more than 3 per day);
• Known allergies to any component of the vaccine;
• Subjects with known allergies to more than 1 planned antibiotics:
• History of diarrhea while traveling in a developing country within the last 3 years;
• Subjects whose occupation involves handling of ETEC or cholera bacteria;
• Women who are pregnant or breastfeeding;
• Significant medical conditions including chronic, immunosuppressive, malignant, or gastrointestinal diseases (e.g. History of Irritable Bowel Syndrome (as defined by the Rome III criteria or medical diagnosis) or gastric ulcer disease) or enteric, pulmonary, cardiac, liver or renal disease. Some medical conditions which are adequately treated and stable may be acceptable in the study (e.g. hypertension);
• Significant abnormalities in screening lab hematology or serum chemistries;
• Use of any medication known to effect the immune system (e.g. systemic corticosteroids) within 30 days of vaccination or planned use during active study period (excluding inhaled steroids);
• Evidence of confirmed infection with HIV, Hepatitis B or Hepatitis C;
• Subjects with IgA (Immunoglobulin A) deficiency (serum IgA \< 7 mg/dl or limit of detection of assay);
• Regular use of antacids, antidiarrheal, loperamide, bismuth subsalicylate, diphenoxylate or similar medication less than 2 weeks prior to enrolling in the study and through the inpatient portion of the study;
• Known or suspected alcohol abuse or illicit drug use within the last year, positive urine toxicology for drugs of abuse;

Sponsors & Collaborators

• Valneva Austria GmbH: lead
• Johns Hopkins University: collaborator
• Naval Medical Research Center: collaborator

Study Sites (1)

Department of International Health Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Talaat KR, Porter CK, Chakraborty S, Feijoo BL, Brubaker J, Adjoodani BM, DeNearing B, Prouty MG, Poole ST, Bourgeois AL, Billingsley M, Sack DA, Eder-Lingelbach S, Taucher C. Validation of a Human Challenge Model Using an LT-Expressing Enterotoxigenic E. coli Strain (LSN03-016011) and Characterization of Potential Amelioration of Disease by an Investigational Oral Vaccine Candidate (VLA1701). Microorganisms. 2024 Apr 3;12(4):727. doi: 10.3390/microorganisms12040727.

  PMID: 38674674 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head Global Medical Affairs
• Organization: Valneva Austria GmbH

info@valneva.com

20620

Study Officials

• Christian Taucher, PhD

  Valneva Austria GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: July 3, 2018
• Study Start: June 4, 2018
• Primary Completion: June 26, 2018
• Study Completion: November 30, 2018
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)