COVID-19 Boosters for People on Immunosuppressive Therapy
Immunosuppression and COVID-19 Boosters
Recruiting
Phase 3
Interventional Study
COVID-19
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 320 (estimated)
- Sponsor
- Kirby Institute · Government
Who this trial is looking for
This trial is looking for adults who have had COVID-19 vaccinations and need to start strong immunosuppressive treatment. Participants will help researchers find out the best timing for COVID-19 booster shots in relation to their immunosuppressive therapy.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have had 2 or more doses of any COVID-19 vaccine more than 3 months ago.
- I need to start moderate-to-severe immunosuppressive therapy for at least 1 year.
- I have not received cyclophosphamide, alemtuzumab, or rituximab in the past 5 years.
- I can provide written consent to participate.
You may not be able to join if
- I am pregnant or breastfeeding.
- I have a primary immunodeficiency.
- I have received or might receive intravenous or subcutaneous immunoglobulin.
- My treatment may involve plasma exchange.
- I cannot receive a SARS-CoV-2 vaccine.
- I am intolerant to or have had an allergic reaction to tetanus vaccination.
- I am switching immunosuppressive therapies and have a low lymphocyte count.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 current…
Trial Locations
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Eligibility 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 immun…
Contacts