Immunosuppression and COVID-19 Boosters
Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
1 other identifier
interventional
320
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Jul 2023
Longer than P75 for phase_3 covid19
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
July 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 24, 2026
February 1, 2026
3.4 years
June 8, 2022
February 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months
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
48 weeks
Secondary Outcomes (6)
Tetanus toxoid NAb response over 12 months
48 weeks
Safety of immediate versus deferred COV-19 booster vaccination
48 weeks
Efficacy of immediate versus deferred COV-19 booster vaccination
48 weeks
Analysis of the response to the SARS-CoV-2 booster vaccination
48 weeks
Assessment of SARS-CoV-2 antibody responses in study populations stratified by their broad qualifying disease types
48 weeks
- +1 more secondary outcomes
Other Outcomes (1)
Level of SARS-CoV-2 protection over time
48 weeks
Study Arms (4)
Group 1 Arm A
ACTIVE COMPARATORImmediate SARS-CoV-2 booster at week 0 and booster of combined diphtheria toxoid/tetanus toxoid (dT vaccine) at week 24.
Group 1 Arm B
ACTIVE COMPARATORdT vaccine at week 0 and SARS-CoV-2 deferred booster at week 24.
Group 2 Arm C
ACTIVE COMPARATORImmediate SARS-CoV-2 booster at week 0.
Group 2 Arm D
ACTIVE COMPARATORDelayed SARS-CoV-2 booster at week 24
Interventions
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.
All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Contraindication to receipt of SARS-CoV-2 vaccine
- Intolerance of or previous allergic reaction to tetanus vaccination
- Patients switching immunosuppressive therapies following enrolment with an absolute lymphocyte count \<0.5 x 109/L immediately prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- Seqirus Pty Ltd, Australiacollaborator
- Medical Research Future Fundcollaborator
Study Sites (5)
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord General Repatriation Hospital
Concord, New South Wales, 2137, Australia
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, 2010, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Related Publications (1)
Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
PMID: 40396505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah C Sasson, PhD
The Kirby Institute UNSW Sydney
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 13, 2022
Study Start
July 21, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share