Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Covid19 Clinical Trial

Official title:

Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05067959
• Other study ID #: 1072-20
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• IBD
• Inflammatory Bowel Diseases

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