Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Rabin Medical Center284 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

284

Conditions

IBD Covid19

Interventions

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rabin Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

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

Time frame: 4 weeks post second COVID-19 vaccine.

Secondary Outcomes

Disease related variant affect immunological response

Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine

Time frame: 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

Time frame: 12 months

Immunologic assessments affect response to vaccine

Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine

Time frame: 12 months

Adverse Events to covid-19 vaccine

Following Adverse reactions to vaccines

Time frame: 12 months

Data from ClinicalTrials.gov

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