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Trial record 1 of 1 for:    NCT02289794
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Vaccine Against Escherichia Coli Infection

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ClinicalTrials.gov Identifier: NCT02289794
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
GlycoVaxyn AG

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.

Condition or disease Intervention/treatment Phase
E.Coli Infections Biological: E.coli bioconjugate vaccine Biological: Placebo Phase 1

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: E.coli bioconjugate vaccine
E.coli bioconjugate vaccine in saline buffer
Biological: E.coli bioconjugate vaccine
Single dose, intramuscular injection (0.5 mL)
Other Name: EcoXyn-4V

Placebo Comparator: Placebo
Saline buffer
Biological: Placebo
Single dose, intramuscular injection (0.5 mL)




Primary Outcome Measures :
  1. Number of subjects experiencing an adverse events [ Time Frame: 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 Outcome Measures :
  1. Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints [ Time Frame: 30 days and 9 months ]
    Evaluation of IgG Response of candidate vaccine between baseline (D1) and post injection (D30 and D270)


Other Outcome Measures:
  1. Reduction of UTI episodes caused by E.coli vaccine-specific serotypes [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289794


Locations
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Switzerland
Hôpitaux Universitaires de Genève
Geneve, GE, Switzerland, 1211
Sponsors and Collaborators
GlycoVaxyn AG
Investigators
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Study Director: Veronica Gambillara, PhD GlycoVaxyn AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlycoVaxyn AG
ClinicalTrials.gov Identifier: NCT02289794    
Other Study ID Numbers: GVXN EC-4V
2013DR1205 ( Other Identifier: swissmedic )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlycoVaxyn AG:
Bioconjugate vaccine
Urinary tract infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Escherichia coli Infections
Urologic Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections