Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Clalit Health Services

Status: Unknown

Conditions: Covid19; IBD

Treatments: Biological: Covid-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05067959

1072-20

Details and patient eligibility

About

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.

Full 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

Enrollment: 284 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

284 participants in 2 patient groups

IBD patients

Description:

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

Treatment:

Biological: Covid-19 vaccine

Controls

Description:

healthy volunteers

Treatment:

Biological: Covid-19 vaccine