Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Kirby Institute
Registry number NCT05415267
Started 21 July 2023 Today 16 October 2026 Estimated completion 31 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Blacktown Hospital Blacktown NSW Recruiting
Royal Prince Alfred Hospital Camperdown NSW Recruiting
Concord General Repatriation Hospital Concord NSW Recruiting
St Vincent's Hospital, Sydney Darlinghurst NSW Recruiting
Westmead Hospital Westmead NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 320

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 21 July 2023
Estimated completion 31 December 2026
Registry last updated 24 February 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 24 February 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.