Clinical Trial: Vaccine Against Escherichia Coli Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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 .


Sponsor: GlycoVaxyn AG

Current Primary Outcome: Number of subjects experiencing an adverse events [ Time Frame: 30 days ]

Occurrence, intensity, relationship and duration of solicited and unsolicited adverse events (AE) and serious adverse events (SAE) post injection of candidate vaccine compared to the placebo group


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints [ Time Frame: 30 days and 9 months ]

Evaluation of IgG Response of candidate vaccine between baseline (D1) and post injection (D30 and D270)


Original Secondary Outcome: Same as current

Information By: GlycoVaxyn AG

Dates:
Date Received: November 3, 2014
Date Started: January 2014
Date Completion:
Last Updated: February 10, 2016
Last Verified: February 2016