Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05415267
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05415267
Study Brief:
Protocol Section:
NCT05415267