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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05067959
Other study ID # 1072-20
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 28, 2020
Est. completion date March 2022

Study information

Verified date October 2021
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

Overall Aims: 1. To assess the immune response to COVID-19 vaccination in patients with IBD. 2. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies. 3. To evaluate the different variables affecting immunity of these patients. 4. To assess adverse reactions to COVID-19 vaccines and IBD related complications. Specifically: 1. To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to 1. Healthy controls 2. Patients with IBD not treated with anti-TNF (+/- immunomodulators) 2. To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD 3. To identify factors associated with serologic response 4. Side effects to vaccines 5. IBD exacerbation compared to activity at baseline 6. Symptomatic COVID-19


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 284
Est. completion date March 2022
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 1. Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Covid-19 vaccine
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

Locations

Country Name City State
Israel Rabin Medical Center Petah Tikva

Sponsors (4)

Lead Sponsor Collaborator
Rabin Medical Center Emek Medical Center, Shaare Zedek Medical Center, Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks post second COVID-19 vaccine.
Secondary Disease related variant affect immunological response Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine 12 months
Secondary 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 12 months
Secondary Immunologic assessments affect response to vaccine Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine 12 months
Secondary Adverse Events to covid-19 vaccine Following Adverse reactions to vaccines 12 months
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