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Screening and Management Practices for Polyoma (BK) Viremia and Nephropathy in Kidney Transplant Recipients From the Lands Down Under: Addressing the Unknowns and Rationale for a Multicenter Clinical TrialBK polyomavirus infection in transplanted kidneys that leads to BK virus–associated nephropathy (BKVAN) is an important cause of allograft loss and has limited treatment options. Recent data suggest that BK viremia affects approximately 10% of people within the first 12 months following kidney transplantation. Among recipients with BKVAN, the overall risk of allograft loss is substantially increased, estimated to be 50% within 5 years of diagnosis.
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A controlled human infection model of Streptococcus pyogenes pharyngitis (CHIVAS-M75): an observational, dose-finding studyStreptococcus pyogenes is a leading cause of infection-related morbidity and mortality. A reinvigorated vaccine development effort calls for new clinically relevant human S pyogenes experimental infection models to support proof of concept evaluation of candidate vaccines. We describe the initial Controlled Human Infection for Vaccination Against S pyogenes (CHIVAS-M75) study, in which we aimed to identify a dose of emm75 S pyogenes that causes acute pharyngitis in at least 60% of volunteers when applied to the pharynx by swab.
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ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trialSARS-CoV-2 infection is associated with a significant risk of hospitalisation, death, and prolonged impact on quality of life. Evaluation of new treatment options and optimising therapeutic management of people hospitalised with SARS-CoV-2 infection remains essential, but rapid changes in pandemic conditions and potential therapies have limited the utility of traditional approaches to randomised controlled trials.
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Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1–9 years: two phase 2 randomised, controlled, observer-blinded studiesThe meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.
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The Impact of a Multifaceted Tertiary Pediatric Hospital's Antimicrobial Stewardship ServiceAntimicrobials are the most commonly prescribed drug class in children. Overuse through inappropriate prescribing is a key driver of antimicrobial resistance and is recognized as one of the top 10 threats to global health by the World Health Organization.
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Biofilms and intracellular infection in otitis mediaOtitis media (OM), middle ear infection, represents a significant burden on children, their families, and the healthcare system. OM is the major cause of hearing loss in children and if left untreated in children who suffer chronic and recurrent forms of OM, this disease can have serious life-long sequelae.
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Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the 'D-Kids' study protocolGlobally, acute respiratory infections (ARIs) are a leading cause of childhood morbidity and mortality. While ARI-related mortality is low in Australia, First Nations infants are hospitalised with ARIs up to nine times more often than their non-First Nations counterparts.
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Safety of BCG vaccination and revaccination in healthcare workersBCG vaccination and revaccination are increasingly being considered for the protection of adolescents and adults against tuberculosis and, more broadly, for the off-target protective immunological effects against other infectious and noninfectious diseases. Within an international randomized controlled trial of BCG vaccination in healthcare workers (the BRACE trial), we evaluated the incidence of local and serious adverse events, as well as the impact of previous BCG vaccination on local injection site reactions (BCG revaccination).
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A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIVTo evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV.
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Western Australian health care workers’ views on mandatory COVID-19 vaccination for the workplaceHealth care workers (HCWs) are at an increased risk of catching and spreading Coronavirus Disease 2019 (COVID-19) compared with the general community, putting health systems at risk. Several jurisdictions globally have mandated or are looking to mandate COVID-19 vaccines for this cohort, but little is known about the acceptability of this measure, especially in different contexts, and there is little qualitative data to explore nuance, depth, and the reasons behind HCWs’ opinions.