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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
34
VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
buffer component of VLA1701
LSN03-016011/A
Department of International Health Johns Hopkins University
Baltimore, Maryland, United States
Percentage of Subjects With Moderate to Severe Diarrhea
within 120 hours of challenge with ETEC strain LSN03-016011/A.
Time frame: 5 days after challenge
Disease Severity Score After Challenge With ETEC Strain LSN03-016011/ A
ETEC diarrhea disease severity score with a score ranging from 0 (no disease) to 8 (most severe disease) utilizing objective signs, subjective Symptoms and stool output.
Time frame: 7 days after challenge
Percentage of Subjects With Solicited Adverse Events
adverse events covered by the subjects memory card
Time frame: 7days after each vaccination
Percentage of Subjects With Any Adverse Events (AE)
Time frame: until Month 6
Number of Subjects With Serious Adverse Events
Time frame: until Month 6
Percentage of Subjects With Any IMP (Investigational Medicinal Product) Related Adverse Events
unsolicited events
Time frame: up to Visit 4 (day of challenge, 23 days post first vaccination)
Percentage of Subjects With IMP-related Serious Adverse Events
Time frame: up to Visit 4 (day of challenge, 23 days post first vaccination)
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