Antibody response to COVID-19 vaccination in immunosuppressed patients with autoimmune disease

Phase 4

Recruiting

• Conditions: Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Crohn's Disease; Ulcerative Colitis; COVID-19; Inflammatory bowel disease; Inflammatory and Immune System - Autoimmune diseases; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12621000661875
• Lead Sponsor: Dr Ai Tran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•18 years or older
•Have an autoimmune rheumatic disease or inflammatory bowel disease
•Treated and stable on immunosuppressive therapy
- Patients who do not have an autoimmune disorder and are not on immunosuppressive therapy will be included as a healthy volunteer cohort

Exclusion Criteria

•Prior vaccination to COVID-19
•Previous history of COVID-19 infection
•Recent prednisolone use within 4 weeks of COVID-19 vaccination
•Inability to have the COVID-19 vaccine
•Previous life threatening or end organ disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody response to the Pfizer/BioNTech COVID-19 mRNA vaccine BNT162b2 using the COVID-19 total and IgG Siemens panel <br>[Weeks 4 & 8 (primary timepoints) and 24<br><br>];Antibody response to the Oxford/Astra Zeneca (ChAdOx1nCov-19) using the COVID-19 total and IgG Siemens panel[Weeks 4 & 16 (primary timepoints) and 24]

Secondary Outcome Measures

Name	Time	Method
Exploratory outcome looking at the cytokine levels in the post vaccination period assessed using plasma multiplex assay for the Pfizer/BioNTech COVID-19 mRNA vaccine.[4 weeks after 1st vaccine dose ];Exploratory outcome looking at the cytokine levels in the post vaccination period assessed using plasma multiplex assay for the Oxford/Astra Zeneca (ChAdOx1nCov-19) vaccine. [4 weeks post vaccination]