Vaccine Against Escherichia Coli Infection

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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E.Coli Infections

Intervention / Treatment
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* Biological: E.coli bioconjugate vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects with a history of recurrent UTI, which is defined as: ≥ 3 UTI independent episodes in the previous 12 months or ≥ 2 UTI episodes in the last 6 months. At least one UTI during the last 5 years was caused by E. coli (as single pathogen or part of polymicrobial infection) and was culture-confirmed and documented Age ≥ 18 and ≤ 70 years Subjects should be in a healthy state without ongoing or suspected symptomatic UTI at the screening visit and at injection day (V2) General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the investigator Willingness to participate in the study after all aspects of the protocol have been explained and fully understood, and written informed consent form obtained Exclusion Criteria: History of more than 10 recurrent UTIs in the year before the screening visit Use of any short-term urinary catheter within 7 days prior to screening Use of any permanent catheter within 30 days prior to screening History of any unresolved urinary tract diseases/abnormalities Evidence of impaired immune function Significant cardiovascular, liver, renal diseases and/or insufficiency Uncontrolled diabetes mellitus Significant abnormalities in screening results for hematology, serum chemistry or urinalysis Positive test for HIV, and/or evidence of HBV or HCV BMI >34 Previous immune stimulatory therapy for UTI prevention (such as Urovaxom®, Strovac® or Urovac®) in the last 3 months, or planned use during the study period Current use of any medication known to affect immune function (e.g. corticosteroids ≥0.5 mg/kg Body weight/day) Use of UTI-related vaginal estrogen treatment newly started less than 6 months before injection and continuing during the study or planned start during the active study period Use of any antibiotic therapy within 1 week preceding injection Planned use of post-coital antibiotics for UTI prevention during study period Any vaccination planned within 30 days before and 30 days after injection Participation in other clinical trials in the 60 days preceding enrolment and for the duration of the study Previous treatment with immunoglobulins or blood products in the 3 months preceding the injection Known hypersensitivity to any component of the vaccine Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study Acute illness at the time of injection Women of child bearing potential who either have a positive pregnancy test or refuse to use an effective contraception Women who are lactating at any time throughout the study period Subjects with an elective surgical intervention, planned during the study period Any other significant finding that in the opinion of the Investigator would increase the risk of having an adverse outcome from participating in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E.coli bioconjugate vaccine<br>E.coli bioconjugate vaccine in saline buffer | Biological: E.coli bioconjugate vaccine<br>* Single dose, intramuscular injection (0.5 mL)<br>* Other names: EcoXyn-4V;|
| Placebo Comparator: Placebo<br>Saline buffer | Biological: Placebo<br>* Single dose, intramuscular injection (0.5 mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing an adverse events | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints | Evaluation of IgG Response of candidate vaccine between baseline (D1) and post injection (D30 and D270) | 30 days and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioconjugate vaccine, Urinary tract infections