Brief 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.

Conditions

• COVID-19

Intervention / Treatment

• Biological: diphtheria and tetanus toxoids (adsorbed) vaccine
• Biological: COVID-19 vaccine

Primary Outcome Measures

• 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

Countries

Australia

Locations and Investigators

• Blacktown Hospital, Blacktown, Australia (Recruiting)
  • Golo Ahlenstiel, MD-PhD
• Royal Prince Alfred Hospital, Camperdown, Australia (Recruiting)
  • Frederick Lee, PhD
• Concord General Repatriation Hospital, Concord, Australia (Recruiting)
  • Judith Trotman, MBChB
• St Vincent's Hospital, Sydney, Darlinghurst, Australia (Recruiting)
  • Anthony Kelleher, PhD
• Westmead Hospital, Westmead, Australia (Recruiting)
  • Sarah Sasson, PhD

Study Officials

• Sarah C Sasson, PhD (Principal Investigator) — The Kirby Institute UNSW Sydney