E.Coli InfectionsPhase 1NCT02289794
Vaccine Against Escherichia Coli Infection
A Phase 1 study testing E.coli bioconjugate vaccine in people with E.Coli Infections, run by GlycoVaxyn AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- E.Coli Infections
- What is being tested?
- E.coli bioconjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- Any vaccination planned within 30 days before and 30 days after injection
- Participation in other clinical trials in the 60 days preceding enrolment and for the duration of the study
- Previous treatment with immunoglobulins or blood products in the 3 months preceding the injection
- Known hypersensitivity to any component of the vaccine
- Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study
- Acute illness at the time of injection
- Women of child bearing potential who either have a positive pregnancy test or refuse to use an effective contraception
- Women who are lactating at any time throughout the study period
- Subjects with an elective surgical intervention, planned during the study period
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection
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.
Read the 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
- Being tested
- E.coli bioconjugate vaccine, Placebo
- Keywords
- Bioconjugate vaccine, Urinary tract infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E.coli bioconjugate vaccineBiological
Also called EcoXyn-4V
Single dose, intramuscular injection (0.5 mL)
PlaceboBiological
Single dose, intramuscular injection (0.5 mL)
| Study group | Role | What they receive |
|---|---|---|
| E.coli bioconjugate vaccine | Active comparator | E.coli bioconjugate vaccine in saline buffer Receives: Biological: E.coli bioconjugate vaccine |
| Placebo | Placebo comparator | Saline buffer Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
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)
Measured: 30 days and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for E.Coli InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoVaxyn AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Gambillara, PhD, Study director, GlycoVaxyn AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289794
- Sponsor's protocol ID
- GVXN EC-4V
- Other IDs
- 2013DR1205
- Status last verified
- Feb 2016
- First submitted
- 3 Nov 2014
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28238601
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT02289794
- Acronym / sponsor ID
- GVXN EC-4V
- Conditions
- E.Coli Infections
- Keywords
- Bioconjugate vaccine, Urinary tract infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- GlycoVaxyn AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E.coli bioconjugate vaccine | Active comparator | Biological: E.coli bioconjugate vaccineE.coli bioconjugate vaccine in saline buffer |
| Placebo | Placebo comparator | Biological: PlaceboSaline buffer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E.coli bioconjugate vaccineAlso: EcoXyn-4VSingle dose, intramuscular injection (0.5 mL) | Biological | E.coli bioconjugate vaccine |
| PlaceboSingle dose, intramuscular injection (0.5 mL) | Biological | Placebo |
Primary outcome
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
1 secondary outcome
Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints
Time frame: 30 days and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Derived from this study: PubMed 28238601Huttner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Gambillara, PhD study director
GlycoVaxyn AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E.coli bioconjugate vaccine in people with E.Coli Infections, run by GlycoVaxyn AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing an adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.