Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

• Conditions: IBD; Covid19
• Interventions: Biological: Covid-19 vaccine

• Registration Number: NCT05067959
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2021-06-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Study First Posted: 2021-10-05
• Last Update Posted: 2021-10-05
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 284

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD patients	Covid-19 vaccine	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
Controls	Covid-19 vaccine	healthy volunteers

Primary Outcome Measures

Name	Time	Method
vaccine efficacy in IBD population	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

Secondary Outcome Measures

Name	Time	Method
Immunologic assessments affect response to vaccine	12 months	Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine
Therapy related variants affect immunological response	12 months	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
Disease related variant affect immunological response	12 months	Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine
Adverse Events to covid-19 vaccine	12 months	Following Adverse reactions to vaccines

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel