Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

NCT ID: NCT05067959

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2022-03-31

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

Conditions

IBD; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IBD patients

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

Covid-19 vaccine

Intervention Type: BIOLOGICAL

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

Controls

healthy volunteers

Covid-19 vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: collaborator

Soroka University Medical Center

OTHER

Sponsor Role: collaborator

Emek Medical Center

OTHER

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

IRIS DOTAN

Head of Gasteroenterology Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

1072-20

Identifier Type: -

Identifier Source: org_study_id