DiphtheriaNCT03998215
Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease
A study testing Diphtheria booster vaccination in people with Diphtheria and Inflammatory Bowel Diseases, run by Medical University of Warsaw.
Trial summary
Assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Diphtheria, Inflammatory Bowel Diseases
- What is being tested?
- Diphtheria booster vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 1 Jan 2015
- 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 11 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),
- vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
- 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.
About this study
Official title: Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease
Assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease.
- Conditions
- Diphtheria, Inflammatory Bowel Diseases
- Being tested
- Diphtheria booster vaccination
- Medical subject headings
- Diphtheria, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria booster vaccinationBiological
Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
| Study group | Role | What they receive |
|---|---|---|
| Diphtheria booster vaccination | Experimental | One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis Receives: Biological: Diphtheria booster vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving seroprotective antibody concentration
Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection.
Measured: after 4-8 weeks
Secondary outcomes (3)
Booster response
Booster response was defined as a post-vaccination antibody concentration ≥0.4 IU/mL in initially seronegative subjects or as a fourfold increase of antibody concentration in initially seropositive ones.
Measured: after 4-8 weeks
Adverse effects
Evaluation of adverse effects after vaccination.
Measured: 3 days
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: after 4-8 weeks
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 start1 Dec 2012
- Primary completion1 Jan 2015
- Study completion1 Jan 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 DiphtheriaStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, Poznan University of Medical Sciences, Medical University of Silesia
- 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
- NCT03998215
- Sponsor's protocol ID
- Dembinski2012
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dembinski L, Krzesiek E, Klincewicz B, Grzybowska-Chlebowczyk U, Demkow U, Banaszkiewicz A, Radzikowski A. Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease. Pediatr Infect Dis J. 2020 Mar;39(3):244-246. doi: 10.1097/INF.0000000000002547.
PubMed 32032309
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03998215
- Acronym / sponsor ID
- Dembinski2012
- Conditions
- Diphtheria, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, Poznan University of Medical Sciences, Medical University of Silesia
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (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 booster immunization against diphtheria 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 |
|---|---|---|
| Diphtheria booster vaccination | Experimental | Biological: Diphtheria booster vaccinationOne booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis |
Who may qualify
- Ages
- 11 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),
- vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
- 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 |
|---|---|---|
| Diphtheria booster vaccinationParticipants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis | Biological | Diphtheria booster vaccination |
Primary outcome
Achieving seroprotective antibody concentration
Time frame: after 4-8 weeks
Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection.
3 secondary outcomes
Booster response
Time frame: after 4-8 weeks
Adverse effects
Time frame: 3 days
Inflammatory bowel disease exacerbation occurrence.
Time frame: after 4-8 weeks
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 26 Jun 2019.
- Derived from this study: PubMed 32032309Dembinski L, Krzesiek E, Klincewicz B, Grzybowska-Chlebowczyk U, Demkow U, Banaszkiewicz A, Radzikowski A. Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease. Pediatr Infect Dis J. 2020 Mar;39(3):244-246. doi: 10.1097/INF.0000000000002547.
- 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.
Aleksandra Banaszkiewicz, MD, PhD study director
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
A study testing Diphtheria booster vaccination in people with Diphtheria and Inflammatory Bowel Diseases, run by Medical University of Warsaw.
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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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: after 4-8 weeks). 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 NCT03998215, 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 26 Jun 2019.