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CompletedPhase 4ACTRN12621000661875

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

Sponsor

Dr Ai Tran

Enrollment

100 participants

Start Date

May 10, 2021

Study Type

Interventional

Conditions

Crohn's DiseaseCOVID-19Ulcerative Colitis

Summary

The aim of the RESCUE study is to collect information on the effectiveness of the Pfizer and Astra Zeneca COVID-19 vaccination in patients with AI disease (autoimmune rheumatic and inflammatory bowel disease). In addition, it will help to determine if stopping current therapy for 1 week after the vaccine will make any difference to the effectiveness of the vaccines. The effectiveness of the vaccines shall be measured by the spike protein antibody levels.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

Patients who are planning to have the COVID-19 vaccination will be followed. Patients having the AstraZenca vaccine will have the vaccination at weeks 0 and 12, while the patients receiving the Pfize

Patients who are planning to have the COVID-19 vaccination will be followed. Patients having the AstraZenca vaccine will have the vaccination at weeks 0 and 12, while the patients receiving the Pfizer vaccination will receive it on weeks 0 and 4. The vaccinations will be provided by their general practitioner. Records from their GP or from My Health Record will be obtained to confirm vaccine administration. The only intervention is some patients will be randomly assigned to withhold their immunosuppressive medications for 1 week after the first vaccine dose only. There are no adherence measures implemented to confirm if patients a compliant to the instructions of continuing or withholding their medication. A member of the research team will instruct the patient which arm they have been assigned to.

Locations(2)

St John of God Hospital, Murdoch - Murdoch

WA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

WA,VIC, Australia

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