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This paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.
We assessed the impact of maternally derived pertussis antibodies on infant responses to a 2 + 1 vaccine schedule (6 weeks, 12 weeks, and 12 months). Infants with baseline antibodies showed lower IgG responses following the primary vaccination series, but this did not impair booster responses at 4 years of age.
Edaravone is used to treat motor neurone disease (MND) by slowing disease progression and prolonging survival time. Currently, it is available as an IV infusion (Radicava®, Jersey City, NJ, USA) and an oral liquid suspension (Radicava ORS®, Jersey City, NJ, USA). Development of novel edaravone formulations is still an active field of research that requires a validated stability-indicating assay capable of providing specific, precise, and accurate quantification of edaravone content.
Older people with cognitive impairment are unrepresented in clinical research. Our objective was to review evidence for strategies to support their research inclusion and participation.
The Australian Therapeutic Goods Administration approved the use of nirsevimab, a long-acting monoclonal antibody for the prevention of Respiratory Syncytial Virus (RSV), in November 2023. Western Australia (WA) implemented a combination of nirsevimab administration strategies designed to protect all infants starting in April 2024, before the epidemic season. We developed a dynamic transmission model to predict the impact of WA's RSV immunisation program on infant hospitalisations.
Despite recent improvements in treatment modalities for cystic fibrosis (CF), there is currently limited evidence and a lack of consensus regarding optimal treatment strategies for the different aspects of CF, including pulmonary exacerbations (PEx). We aimed to establish a prospective cohort of people with CF (pwCF) to evaluate alternative approaches to managing CF in the era of modulator therapies.
To inform the design of a United Kingdom (UK) paediatric teleotology pilot by analysing global teleotology initiatives and drawing on insights from a successful paediatric teleotology pilot service in Perth, Western Australia (Ear Portal).
To assess the impact of implementing a sepsis pathway and education program on key sepsis outcomes and performance targets in a tertiary paediatric hospital.
Vaccine policy and guideline recommendations require high quality evidence. A review of the evidence quality used to inform vaccine clinical practice guidelines could help guide researchers on how to improve the design of their clinical studies to produce evidence of greater value to decision-makers.
A birth acellular pertussis vaccine may be a valuable alternative for immunity against infant pertussis when a pregnancy pertussis vaccine has not been administered. We assessed whether a birth dose may impair immunoglobulin G (IgG) responses to childhood pertussis boosters.