Vaccine Against Escherichia Coli Infection

E.Coli Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289794
• Other study ID #: GVXN EC-4V
• Secondary ID: 2013DR1205
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2014
• Last updated: February 10, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: GlycoVaxyn AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• E.Coli Infections
• Escherichia coli Infections
• Infection
• Urinary Tract Infections

Intervention

Biological:
• E.coli bioconjugate vaccine
Single dose, intramuscular injection (0.5 mL)
• Placebo
Single dose, intramuscular injection (0.5 mL)

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneve	GE

Sponsors (1)

Lead Sponsor	Collaborator
GlycoVaxyn AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of UTI episodes caused by E.coli vaccine-specific serotypes	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	No
Primary	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	No
Secondary	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	No