Status:
COMPLETED
Vaccine Against Escherichia Coli Infection
Lead Sponsor:
GlycoVaxyn AG
Conditions:
E.Coli Infections
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
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 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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT02289794
Start Date
January 1 2014
End Date
September 1 2015
Last Update
February 11 2016
Active Locations (1)
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1
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1211