RecruitingPhase 3NCT05415267

Immunosuppression and COVID-19 Boosters

Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy


Sponsor

Kirby Institute

Enrollment

320 participants

Start Date

Jul 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called COVID-19 vaccine and a biological treatment called diphtheria and tetanus toxoids (adsorbed) vaccine for people with covid-19. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALdiphtheria 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.

BIOLOGICALCOVID-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

View Full Details on ClinicalTrials.gov

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NCT05415267


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