Vaccine Against Escherichia Coli Infection

NCT02289794 | Completed Phase 1 DMC

• 2 other identifiers: GVXN EC-4V2013DR1205
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

E.Coli Infections

Keywords

Bioconjugate vaccine; Urinary tract infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints

  30 days and 9 months

Other Outcomes (1)

• Reduction of UTI episodes caused by E.coli vaccine-specific serotypes

  9 months

Study Arms (2)

E.coli bioconjugate vaccine

ACTIVE COMPARATOR

E.coli bioconjugate vaccine in saline buffer

Biological: E.coli bioconjugate vaccine

Placebo

PLACEBO COMPARATOR

Saline buffer

Biological: Placebo

Interventions

E.coli bioconjugate vaccine BIOLOGICAL

Single dose, intramuscular injection (0.5 mL)

Also known as: EcoXyn-4V

E.coli bioconjugate vaccine

Placebo BIOLOGICAL

Single dose, intramuscular injection (0.5 mL)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18 and ≤ 70 years
• Subjects should be in a healthy state without ongoing or suspected symptomatic UTI at the screening visit and at injection day (V2)
• General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the investigator
• Willingness to participate in the study after all aspects of the protocol have been explained and fully understood, and written informed consent form obtained

You may not qualify if:

• History of more than 10 recurrent UTIs in the year before the screening visit
• Use of any short-term urinary catheter within 7 days prior to screening
• Use of any permanent catheter within 30 days prior to screening
• History of any unresolved urinary tract diseases/abnormalities
• Evidence of impaired immune function
• Significant cardiovascular, liver, renal diseases and/or insufficiency
• Uncontrolled diabetes mellitus
• Significant abnormalities in screening results for hematology, serum chemistry or urinalysis
• Positive test for HIV, and/or evidence of HBV or HCV
• BMI \>34
• 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
• Current use of any medication known to affect immune function (e.g. corticosteroids ≥0.5 mg/kg Body weight/day)
• 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
• Use of any antibiotic therapy within 1 week preceding injection
• Planned use of post-coital antibiotics for UTI prevention during study period

Sponsors & Collaborators

• GlycoVaxyn AG: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28238601 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Veronica Gambillara, PhD

  GlycoVaxyn AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 13, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)