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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Voluntarily given written informed consent

Locations
Other Locations
Australia
Blacktown Hospital
RECRUITING
Blacktown
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Concord General Repatriation Hospital
RECRUITING
Concord
St Vincent's Hospital, Sydney
RECRUITING
Darlinghurst
Westmead Hospital
RECRUITING
Westmead
Contact Information
Primary
Dianne L Carey, PhD
dcarey@kirby.unsw.edu.au
+61 2 9385 0908
Time Frame
Start Date: 2023-07-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 320
Treatments
Active_comparator: Group 1 Arm A
Immediate SARS-CoV-2 booster at week 0 and booster of combined diphtheria toxoid/tetanus toxoid (dT vaccine) at week 24.
Active_comparator: Group 1 Arm B
dT vaccine at week 0 and SARS-CoV-2 deferred booster at week 24.
Active_comparator: Group 2 Arm C
Immediate SARS-CoV-2 booster at week 0.
Active_comparator: Group 2 Arm D
Delayed SARS-CoV-2 booster at week 24
Sponsors
Collaborators: Seqirus Pty Ltd, Australia, Medical Research Future Fund
Leads: Kirby Institute

This content was sourced from clinicaltrials.gov