CholeraNCT03998449
Immunogenicity of Cholera Vaccine in Children With IBD
A study testing Vaccination against cholera in people with Cholera and Inflammatory Bowel Diseases, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cholera, Inflammatory Bowel Diseases
- What is being tested?
- Vaccination against cholera
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 30 Aug 2017to 1 May 2020
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
- no vaccination against cholera in the past,
- written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
Who cannot join
- serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
- Conditions
- Cholera, Inflammatory Bowel Diseases
- Being tested
- Vaccination against cholera
- Medical subject headings
- Cholera, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination against choleraBiological
Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cholera vaccination | Experimental | Two doses of the vaccine against cholera Receives: Biological: Vaccination against cholera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving seroprotective antibody concentration
Serum antibody concentration indicating protection against cholera.
Measured: 4-6 weeks after the second dose
Secondary outcomes (2)
Adverse effects
Evaluation of adverse effects after vaccination.
Measured: 3 days after each dose
Inflammatory bowel disease exacerbation occurrence.
Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
Measured: 4-6 weeks after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start30 Aug 2017
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholeraStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Principal investigator, Lukasz Dembinski, Medical University of Warsaw
- Investigators
- Aleksandra Banaszkiewicz, MD, PhD, Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998449
- Sponsor's protocol ID
- Dembinski2019
- Status last verified
- May 2020
- First submitted
- 24 Jun 2019
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03998449
- Acronym / sponsor ID
- Dembinski2019
- Conditions
- Cholera, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- 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.
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholera vaccination | Experimental | Biological: Vaccination against choleraTwo doses of the vaccine against cholera |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
- no vaccination against cholera in the past,
- written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
Key exclusion criteria (1 listed)
- serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.
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 |
|---|---|---|
| Vaccination against choleraParticipants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks. | Biological | Cholera vaccination |
Primary outcome
Achieving seroprotective antibody concentration
Time frame: 4-6 weeks after the second dose
Serum antibody concentration indicating protection against cholera.
2 secondary outcomes
Adverse effects
Time frame: 3 days after each dose
Inflammatory bowel disease exacerbation occurrence.
Time frame: 4-6 weeks after the second dose
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 20 May 2020.
- Individual participant dataSharing planned: No
Related trials for Cholera
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Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
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Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population
Bowel Habits, Gut Microbiomes
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
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CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Enrolling by invitationPhase 4
A Post-marketing Observational Study of Oral Cholera Vaccine
Diarrhea
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.
Aleksandra Banaszkiewicz, MD, PhD study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination against cholera in people with Cholera and Inflammatory Bowel Diseases, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 1 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 20 May 2020. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Achieving seroprotective antibody concentration (time frame: 4-6 weeks after the second dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.