Status:
RECRUITING
Immunosuppression and COVID-19 Boosters
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Seqirus Pty Ltd, Australia
Medical Research Future Fund
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sev...
Detailed Description
Current guidelines for SARS-CoV2 vaccination in immunosuppressed populations are based on limited evidence. Additionally, guidelines for the use of SARS-CoV2 vaccines in autoimmune populations are som...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05415267
Start Date
July 21 2023
End Date
December 31 2026
Last Update
July 25 2025
Active Locations (5)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
Concord General Repatriation Hospital
Concord, New South Wales, Australia, 2137
4
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010