Immunosuppression and COVID-19 Boosters

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months — 48 weeks
  Integrated time-weighted area under the curve (AUC) change from baseline in anti-SARS- CoV-2 NAb over 12 months from a SARS-CoV-2 booster vaccination

Trial sites (5)

More Kirby Institute trials in Australia

Other trials for the same condition