Vaccine Against Escherichia Coli Infection

NCT ID: NCT02289794

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-30

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 .

Conditions

E.Coli Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

E.coli bioconjugate vaccine

E.coli bioconjugate vaccine in saline buffer

Group Type: ACTIVE_COMPARATOR

E.coli bioconjugate vaccine

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection (0.5 mL)

Placebo

Saline buffer

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection (0.5 mL)

Interventions

E.coli bioconjugate vaccine

Single dose, intramuscular injection (0.5 mL)

Intervention Type: BIOLOGICAL

Placebo

Single dose, intramuscular injection (0.5 mL)

Intervention Type: BIOLOGICAL

Other Intervention Names

EcoXyn-4V

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlycoVaxyn AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica Gambillara, PhD

Role: STUDY_DIRECTOR

GlycoVaxyn AG

Locations

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

Huttner A, Hatz C, van den Dobbelsteen G, Abbanat D, Hornacek A, Frolich R, Dreyer AM, Martin P, Davies T, Fae K, van den Nieuwenhof I, Thoelen S, de Valliere S, Kuhn A, Bernasconi E, Viereck V, Kavvadias T, Kling K, Ryu G, Hulder T, Groger S, Scheiner D, Alaimo C, Harbarth S, Poolman J, Fonck VG. Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial. Lancet Infect Dis. 2017 May;17(5):528-537. doi: 10.1016/S1473-3099(17)30108-1. Epub 2017 Feb 24.

Reference Type: DERIVED

PMID: 28238601 (View on PubMed)

Other Identifiers

2013DR1205

Identifier Type: OTHER

Identifier Source: secondary_id

GVXN EC-4V

Identifier Type: -

Identifier Source: org_study_id