Immunosuppression and COVID-19 Boosters

ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

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 criteria

Qualifiers

Adult aged at least 18 years

Previously vaccinated with 2 (or more) doses of any licensed COVID-19 vaccine who requires initiation of moderate-to-severe immunosuppression; most recent COVID-19 vaccine dose must have been given > 3 months prior

Planned significant immunosuppressive therapy for at least 1 year

No cyclophosphamide, alemtuzumab or rituximab treatment in the past 5 years. Note: patient may have concurrent steroids with any treatments listed in protocol

Disqualifiers

Pregnant or breastfeeding

Has underlying primary immunodeficiency

Has received or likely to receive intravenous/subcutaneous immunoglobulin (IVIg/ScIg).

Projected treatment is likely to involve plasma exchange

Trial design

Treatments tested in this trial

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

Treatment groups

320 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Kirby Institute

Lead sponsor

Seqirus Pty Ltd, Australia

Collaborator

Medical Research Future Fund

Collaborator