Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

NCT05067959 | Unknown

• 1 other identifier: 1072-20
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease related variant affect immunological response

  12 months

• Therapy related variants affect immunological response

  12 months

• Immunologic assessments affect response to vaccine

  12 months

• Adverse Events to covid-19 vaccine

  12 months

Study Arms (2)

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

Biological: Covid-19 vaccine

Controls

healthy volunteers

Biological: Covid-19 vaccine

Interventions

Covid-19 vaccine 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; IBD patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IBD patients and healthy volunteers

You may qualify if:

• \. 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

You may not qualify if:

• \. Pregnant women

Sponsors & Collaborators

• Rabin Medical Center: lead
• Shaare Zedek Medical Center: collaborator
• Soroka University Medical Center: collaborator
• Emek Medical Center: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

complete blood count, CRP, Anti-TNF level and trough from relevant patients, COVID-19 serology including neutralizing antibodies, cytokine levels, lymphocyte subpopulation \[CD4 CD8 B CD20/19, NKT\], T cell proliferation, immunoglobulin levels.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gasteroenterology Division

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: October 5, 2021
• Study Start: December 28, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)