Evidence map›Paper›PMID 42031476›Full record

ArticleBMJ open2026

Comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT): study protocol for a randomised, controlled clinical trial.

Dianne L Carey, Golo Ahlenstiel, Fabienne Brilot, David A Brown, Rowena Bull, Helen Crowther, Anthony Cunningham, Miles P Davenport, Peter Diamond, Nada Hamad and 12 more

Registry-linked trialAbstract readClinical Trial ProtocolComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05415267 (Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05415267 phase3recruitingnot on this map

Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy

TypeinterventionalSponsorKirby InstituteRan2023 to 2026Enrolled320ConditionsCOVID-19Armsdiphtheria and tetanus toxoids (adsorbed) vaccine, COVID-19 vaccine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Dianne L CareyThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0003-0156-8143
Golo AhlenstielDepartment of Gastroenterology, Blacktown and Mount Druitt Hospital, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0003-0026-1457
Fabienne BrilotKids Research, The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
David A BrownThe University of Sydney, Sydney, New South Wales, Australia.
Rowena BullThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Helen CrowtherDepartment of Haematology, Blacktown and Mount Druitt Hospital, Blacktown, New South Wales, Australia.
Anthony CunninghamThe University of Sydney, Sydney, New South Wales, Australia.
Miles P DavenportThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Peter DiamondLeukaemia Foundation, Brisbane, Queensland, Australia.
Nada HamadUniversity of New South Wales, Sydney, New South Wales, Australia.
Amanda JohnstonNew South Wales Health Pathology, ICPMR, Sydney, New South Wales, Australia.
Anthony D KelleherDepartment of Clinical Immunology, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
Frederick J LeeThe University of Sydney, Sydney, New South Wales, Australia.
Gail V MatthewsDepartment of Infectious Diseases, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
Kathy PetoumenosThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Gesalit C QuichuaThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Sanjay SwaminathanWestern Sydney University, Sydney, New South Wales, Australia.
Judith TrotmanThe University of Sydney, Sydney, New South Wales, Australia.
Stuart TurvilleThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Steve VukicBrain and Nerve Research Centre, The University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-8323-873X
Peter WongThe University of Sydney, Sydney, New South Wales, Australia.
Sarah C SassonThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia ssasson@kirby.unsw.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImmunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40). METHODS AND ANALYSIS: The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses. ETHICS AND DISSEMINATION: The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 - 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported. TRIAL REGISTRATION NUMBER: NCT05415267.

Indexed as

COVID-19COVID-19 VaccinesImmunization, SecondaryImmunosuppression TherapyImmunosuppressive AgentsAntibodies, ViralBone Marrow TransplantationHumansImmunoglobulin GSARS-CoV-2Antibodies, ViralCOVID-19 VaccinesImmunoglobulin GImmunosuppressive AgentsCOVID-19ImmunitySARS-CoV-2 InfectionVaccination

Identifiers

PMID42031476
PMCPMC13110584

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.