Timing of COVID-19 booster vaccinations for immunosuppressed patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.