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RECRUITING
NCT05415267
PHASE3

Immunosuppression and COVID-19 Boosters

Sponsor: Kirby Institute

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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