Immunosuppression 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).
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.
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.
by Sian E. Wanstall, Brandon W. J. Brown, Meagan E. Crowther, Claire Dunbar, Robert J. Adams, Anjum Naweed, Amy C. Reynolds
BackgroundParamedics face unique occupational hazards, including high operational demands, trauma exposure, and shift work, all of which impact mental well-being. Suboptimal sleep is also common in this workforce and closely linked to adverse mental health outcomes. This scoping review synthesizes evidence to date on interventions to support paramedic mental well-being including sleep-based interventions.
Materials and methodsThis review was pre-registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/7VSD9). Systematic database searches were conducted in October 2024 for original research published after 2004. Data were narratively synthesised, and findings reported following established guidelines.
ResultsNineteen sources were included, involving 1,067 participants across seven countries. Seventeen interventions were examined, predominantly via randomized controlled trials (58%), utilizing a total of 43 different measurement scales to evaluate mental health and sleep outcomes. Interventions included psychological (37%), sleep, fatigue and/or shift work (32%), and complementary and alternative medicine (32%) approaches which primarily focussed on the individual-level (94%). Studies were limited by sample sizes, design and quality, limited long term follow-up, and low baseline symptoms.
ConclusionsThis review highlights a critical gap in robust, evidence-based, system-level interventions to address poor sleep and mental well-being in paramedics. Future research should prioritise co-designed, context-sensitive approaches, ideally integrated within organisational structures to ensure relevance and accessibility.