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Immunosuppression and COVID-19 Boosters
Sponsor: Kirby Institute
Summary
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.
Official title: Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2023-07-21
Completion Date
2026-12-31
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
diphtheria and tetanus toxoids (adsorbed) vaccine
The diphtheria/tetanus toxoids vaccine will be given to participants enrolled into Group 1 as a comparator vaccine to the mRNA COVID-19 booster vaccine with the aim of determining whether the results related to COVID-19 vaccine timing also apply to more traditional protein-based vaccines.
COVID-19 vaccine
All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm
Locations (5)
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord General Repatriation Hospital
Concord, New South Wales, Australia
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia