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When to boost? new trial seeks best COVID-19 shot timing for vulnerable patients

NCT ID NCT05415267

Knowledge-focused Sponsor: Kirby Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 320 adults who are about to start strong immune-suppressing therapy and have already had at least two COVID-19 shots. Researchers want to find out if giving a COVID-19 booster right before starting therapy or waiting six months provides better protection. Participants will also receive a diphtheria/tetanus booster to compare how the immune system responds to different vaccines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COVID-19 booster vaccine and diphtheria/tetanus toxoids vaccine
What this could lead to
If successful, this could help doctors choose the best time to give COVID-19 boosters to people starting immunosuppressive therapy, improving their protection against severe illness.
What could go wrong
This is a Phase 3 trial, but it focuses on timing rather than a new treatment. Results may not apply to all types of immunosuppression or vaccines, and individual responses may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune disease hematopoietic and lymphoid cell neoplasm inflammatory disease COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Blacktown Hospital

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • Concord General Repatriation Hospital

    RECRUITING

    Concord, New South Wales, 2137, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • St Vincent's Hospital, Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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