None listed
Conditions
Brief 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.
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 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 im
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.
Sponsors
Dr Ai Tran
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Outcome results
None listed