Timing of COVID-19 booster vaccinations for immunosuppressed patients
Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
This study is testing whether giving COVID-19 booster shots right before or six months after starting immunosuppressive therapy helps people with autoimmune and inflammatory conditions stay protected better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kirby Institute Government |
| Drugs / interventions | alemtuzumab, rituximab, cyclophosphamide, vedoluzimab, ocrelizumab, ofatumumab, sekukinumab, chemotherapy, methotrexate |
| Locations | 5 sites (Blacktown, New South Wales and 4 other locations) |
| Trial ID | NCT05415267 on ClinicalTrials.gov |
What this trial studies
This research investigates the optimal timing for administering COVID-19 booster vaccinations to patients who are about to start moderate-to-severe immunosuppressive therapy. The study compares the effectiveness of giving the booster just before the initiation of immunosuppression versus waiting six months after treatment begins. By focusing on patients with autoimmune and inflammatory conditions, the study aims to address gaps in current vaccination guidelines and provide evidence-based recommendations. The approach is pragmatic and real-world, considering the diverse patient population receiving various immunosuppressive therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received at least two doses of a COVID-19 vaccine and require significant immunosuppressive therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have underlying primary immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the protection of immunosuppressed patients against severe COVID-19 illness.
How similar studies have performed: Other studies have shown varying success in optimizing vaccination strategies for immunosuppressed populations, but this specific timing approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Blacktown, New South Wales and 4 other locations
- Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Concord General Repatriation Hospital — Concord, New South Wales, Australia (Recruiting)
- St Vincent's Hospital, Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Sarah C Sasson, PhD — The Kirby Institute UNSW Sydney
- Study coordinator: Dianne L Carey, PhD
- Email: dcarey@kirby.unsw.edu.au
- Phone: +61 2 9385 0908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.