- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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GE
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Geneve, GE, Switzerland, 1211
- Hopitaux Universitaires de Geneve
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E.coli bioconjugate vaccine
E.coli bioconjugate vaccine in saline buffer
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Single dose, intramuscular injection (0.5 mL)
Other Names:
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Placebo Comparator: Placebo
Saline buffer
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Single dose, intramuscular injection (0.5 mL)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects experiencing an adverse events
Time Frame: 30 days
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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
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints
Time Frame: 30 days and 9 months
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Evaluation of IgG Response of candidate vaccine between baseline (D1) and post injection (D30 and D270)
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30 days and 9 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of UTI episodes caused by E.coli vaccine-specific serotypes
Time Frame: 9 months
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Comparison of the number of symptomatic UTI episodes caused by E. coli vaccine-serotypes between the two arms, injected with candidate-vaccine or placebo during the whole study period
|
9 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Veronica Gambillara, PhD, GlycoVaxyn AG
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GVXN EC-4V
- 2013DR1205 (Other Identifier: swissmedic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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