Actively Recruiting
Immunosuppression and COVID-19 Boosters
Led by Kirby Institute · Updated on 2026-02-24
320
Participants Needed
5
Research Sites
179 weeks
Total Duration
On this page
Sponsors
K
Kirby Institute
Lead Sponsor
S
Seqirus Pty Ltd, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.
CONDITIONS
Official Title
Immunosuppression and COVID-19 Boosters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged at least 18 years
- Previously vaccinated with 2 or more doses of any licensed COVID-19 vaccine, with the most recent dose given more than 3 months ago
- Planned moderate-to-severe immunosuppressive therapy for at least 1 year
- No treatment with cyclophosphamide, alemtuzumab, or rituximab in the past 5 years
- Provided voluntary written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Has primary immunodeficiency
- Has received or is likely to receive intravenous or subcutaneous immunoglobulin (IVIg/ScIg)
- Planned treatment likely to include plasma exchange
- Contraindicated for SARS-CoV-2 vaccination
- Intolerant of or had allergic reaction to tetanus vaccination
- Switching immunosuppressive therapies with absolute lymphocyte count less than 0.5 x 10^9/L immediately before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
3
Concord General Repatriation Hospital
Concord, New South Wales, Australia, 2137
Actively Recruiting
4
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
5
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
D
Dianne L Carey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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