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New study aims to shield vulnerable groups from COVID-19

NCT ID NCT05556720

Vaccine Sponsor: Monash University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether extra COVID-19 vaccine doses are safe and work well for people with weakened immune systems, such as those with HIV, organ transplants, or blood cancers. Around 960 participants will receive different booster schedules to see which one boosts their protection best. The goal is to find the best way to keep these high-risk individuals safe from severe COVID-19.

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 960 people

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

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

16 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: * Able to give informed consent and undertake study procedures * Age ≥16 years old * Have completed at least 3 months prior, 3- to 8-doses of an Australian TGA approved SARS-CoV-2 vaccine (including mRNA \[Pfizer or Moderna\], ChAdOx1 \[Oxford/Astra Zeneca\] or protein \[Novavax\]) * Fit the criteria to be included in one of the following 3 populations: Infected with HIV; Current recipient of a solid organ transplant including: kidney, pancreas, liver, malignancy episodes of severe rejection requiring T- or B-cell depleting agents in the prior 3 months; Undergoing chemotherapy, immunotherapy and/or targeted therapy, or completed in the last 2 years for: chronic lymphocytic leukemia, multiple myeloma or non-Hodgkin lymphoma. Exclusion Criteria: * Are contraindicated to receive a COVID-19 booster vaccination, e.g. history of anaphylaxis to a vaccine component or myocarditis attributed to previous receipt of an mRNA vaccine. * Has had less than 3 or more than 8 doses of COVID-19 vaccine * Is on another clinical trial investigating alternate COVID-19 vaccination schedules or investigational drugs to prevent or treat COVID-19 * Life expectancy \< 12 months, or enrolment deemed not in the best interest of the patient * Unable to provide informed consent * Receipt of SARS-CoV-2 specific monoclonal antibodies in the 3 months prior to receiving the first dose of study vaccine * Acute respiratory tract infection and/or temperature \> 38 degrees centigrade on day of receiving first dose of study vaccine * History of autologous stem cell transplant in the prior 6 months or history of ever having an allogeneic stem cell transplant or CAR T-cell therapy * Have not received another licensed vaccine in the 7 days before or 7 days after the day of receiving the COVID-19 study vaccine (NOTE: Participants can receive another licensed vaccine on the same day as the COVID-19 vaccine)

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia HIV infectious disease lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma plasma cell myeloma COVID-19 prevention target

As listed by the trial registrant

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

Chronic lymphocytic leukemia COVID-19 vaccines HIV Lymphoma, non-Hodgkin Multiple myeloma Organ transplantation

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince Of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029, Australia

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3000, Australia

  • St Vincents Hospital

    Darlinghurst, New South Wales, Australia

  • St Vincents Hospital

    Fitzroy, Victoria, 3065, Australia

  • University Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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