Vaccine Against Escherichia Coli Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT02289794
• Date of registration: 03/11/2014
• Prospective Registration: No
• Primary sponsor: GlycoVaxyn AG
• Public title: Vaccine Against Escherichia Coli Infection
• Scientific title: Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection
• Date of first enrolment: January 2014
• Target sample size: 194
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02289794
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Switzerland

Contacts

• Name: Veronica Gambillara, PhD
• Affiliation: GlycoVaxyn AG

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

E.Coli Infections

Intervention(s)

Biological: Placebo

Biological: E.coli bioconjugate vaccine

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

2013DR1205

GVXN EC-4V

Source(s) of Monetary Support

Please refer to primary and secondary sponsors