IBDNCT05067959
Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
An observational study of IBD and Covid19, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Covid-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 284 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Dec 2020to Mar 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: IBD patients and healthy volunteers
Who may be able to join
- 1. Adults >18 years of age 2. Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 [i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection 4. Ability to attend follow up visits 5. Ability to understand and sign an informed consent form
Who cannot join
- 1. Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.
Read the detailed description
Overall Aims:
- To assess the immune response to COVID-19 vaccination in patients with IBD.
- Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
- To evaluate the different variables affecting immunity of these patients.
- To assess adverse reactions to COVID-19 vaccines and IBD related complications.
Specifically:
- To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
- Healthy controls
- Patients with IBD not treated with anti-TNF (+/- immunomodulators)
- To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
- To identify factors associated with serologic response
- Side effects to vaccines
- IBD exacerbation compared to activity at baseline
- Symptomatic COVID-19
- Being tested
- Covid-19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccineBiological
blood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | patients with IBD (Chron's disease, Ulcerative colitis, IBD-Unspecify). patients will be divided into two sub-groups: IBD patients on anti-TNF therapy IBD patients on any other therapy Receives: Biological: Covid-19 vaccine | |
| Controls | healthy volunteers Receives: Biological: Covid-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaccine efficacy in IBD population
- Efficacy of the vaccination for IBD patients compared to the normal population measured as proportion of patients achieving positive serology
Measured: 4 weeks post second COVID-19 vaccine.
Secondary outcomes (4)
Disease related variant affect immunological response
Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine
Measured: 12 months
Therapy related variants affect immunological response
Measuring how specific IBD therapies and doses, during induction or maintenance, interval between vaccination and anti TNF infusion/injection affect the response to the vaccine
Measured: 12 months
Immunologic assessments affect response to vaccine
Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine
Measured: 12 months
Adverse Events to covid-19 vaccine
Following Adverse reactions to vaccines
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start28 Dec 2020
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center, Soroka University Medical Center, Emek Medical Center
- Responsible party
- Principal investigator, IRIS DOTAN, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067959
- Sponsor's protocol ID
- 1072-20
- Status last verified
- Oct 2021
- First submitted
- 21 Jun 2021
- Last updated
- 5 Oct 2021
- 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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT05067959
- Acronym / sponsor ID
- 1072-20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center, Soroka University Medical Center, Emek Medical Center
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.
Detailed description
Overall Aims:
- To assess the immune response to COVID-19 vaccination in patients with IBD.
- Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
- To evaluate the different variables affecting immunity of these patients.
- To assess adverse reactions to COVID-19 vaccines and IBD related complications.
Specifically:
- To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
- Healthy controls
- Patients with IBD not treated with anti-TNF (+/- immunomodulators)
- To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
- To identify factors associated with serologic response
- Side effects to vaccines
- IBD exacerbation compared to activity at baseline
- Symptomatic COVID-19
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Biological: Covid-19 vaccinepatients with IBD (Chron's disease, Ulcerative colitis, IBD-Unspecify). patients will be divided into two sub-groups: IBD patients on anti-TNF therapy IBD patients on any other therapy |
| Controls | – | Biological: Covid-19 vaccinehealthy volunteers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IBD patients and healthy volunteers
Key inclusion criteria (1 listed)
- 1. Adults >18 years of age 2. Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 [i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection 4. Ability to attend follow up visits 5. Ability to understand and sign an informed consent form
Key exclusion criteria (1 listed)
- 1. Pregnant women
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 |
|---|---|---|
| Covid-19 vaccineblood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine | Biological | Controls, IBD patients |
Primary outcome
vaccine efficacy in IBD population
Time frame: 4 weeks post second COVID-19 vaccine.
• Efficacy of the vaccination for IBD patients compared to the normal population measured as proportion of patients achieving positive serology
4 secondary outcomes
Disease related variant affect immunological response
Time frame: 12 months
Therapy related variants affect immunological response
Time frame: 12 months
Immunologic assessments affect response to vaccine
Time frame: 12 months
Adverse Events to covid-19 vaccine
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Covid19, run by Rabin Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. 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 Israel. 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?
Results are not available in the source record.
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?
vaccine efficacy in IBD population (time frame: 4 weeks post second COVID-19 vaccine.). 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 5 Oct 2021.