E.Coli Infections
Conditions
Keywords
Bioconjugate vaccine, Urinary tract infections
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 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 .
Interventions
BIOLOGICALE.coli bioconjugate vaccine
Single dose, intramuscular injection (0.5 mL)
BIOLOGICALPlacebo
Single dose, intramuscular injection (0.5 mL)
Sponsors
GlycoVaxyn AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Age ≥ 18 and ≤ 70 years 3. Subjects should be in a healthy state without ongoing or suspected symptomatic UTI at the screening visit and at injection day (V2) 4. General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the investigator 5. 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
1. History of more than 10 recurrent UTIs in the year before the screening visit 2. Use of any short-term urinary catheter within 7 days prior to screening 3. Use of any permanent catheter within 30 days prior to screening 4. History of any unresolved urinary tract diseases/abnormalities 5. Evidence of impaired immune function 6. Significant cardiovascular, liver, renal diseases and/or insufficiency 7. Uncontrolled diabetes mellitus 8. Significant abnormalities in screening results for hematology, serum chemistry or urinalysis 9. Positive test for HIV, and/or evidence of HBV or HCV 10. BMI \>34 11. 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 12. Current use of any medication known to affect immune function (e.g. corticosteroids ≥0.5 mg/kg Body weight/day) 13. 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 14. Use of any antibiotic therapy within 1 week preceding injection 15. Planned use of post-coital antibiotics for UTI prevention during study period 16. Any vaccination planned within 30 days before and 30 days after injection 17. Participation in other clinical trials in the 60 days preceding enrolment and for the duration of the study 18. Previous treatment with immunoglobulins or blood products in the 3 months preceding the injection 19. Known hypersensitivity to any component of the vaccine 20. Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study 21. Acute illness at the time of injection 22. Women of child bearing potential who either have a positive pregnancy test or refuse to use an effective contraception 23. Women who are lactating at any time throughout the study period 24. Subjects with an elective surgical intervention, planned during the study period 25. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects experiencing an adverse events | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints | 30 days and 9 months | Evaluation of IgG Response of candidate vaccine between baseline (D1) and post injection (D30 and D270) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduction of UTI episodes caused by E.coli vaccine-specific serotypes | 9 months | 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 |
Countries
Switzerland
Outcome results
None listed