NCT02289794

Vaccine Against Escherichia Coli Infection

Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: GlycoVaxyn AG · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This Phase I multi-center placebo controlled study is conducted in healthy women with a history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.

Detailed description

GlycoVaxyn is a Swiss company that has developed a multivalent bioconjugate vaccine for the prevention of E.coli-infections. Cystitis is the most common UTI, however kidney infections or bacteremia are possible. The E. coli bacterium is responsible for 85 % of all UTIs. The objectives of this trial are to assess the safety and ability to elicit an immune response of the candidate vaccine as well as the effectiveness of the vaccine in the reduction in UTIs .

Conditions

• E.Coli Infections

Interventions

Type	Name	Description
BIOLOGICAL	E.coli bioconjugate vaccine	Single dose, intramuscular injection (0.5 mL)
BIOLOGICAL	Placebo	Single dose, intramuscular injection (0.5 mL)

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2014-11-13
• Last updated: 2016-02-11

Locations

1 site across 1 country: Switzerland