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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.
We have read with interest the new publication by Rouhiainen and colleagues on missed opportunities for preventing or diagnosing acute rheumatic fever (ARF).
This review aims to systematically identify contextual and mechanistic factors that contribute to the success or failure of implementing effective HCs in the prevention and early detection of chronic diseases among Aboriginal and Torres Strait Islander people in Australian primary health care (PHC).
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.
Tools that can be used to collect behavioural data during pandemics are needed to inform policy and practice. The objective of this project was to develop the Your COVID-19 Risk tool in response to the global spread of COVID-19, aiming to promote health behaviour change. We developed an online resource based on key behavioural evidence-based risk factors related to contracting and spreading COVID-19. This tool allows for assessing risk and provides instant support to protect individuals from infection.
Nirsevimab is a long-acting monoclonal antibody used to prevent respiratory syncytial virus (RSV) infection in infants and high-risk children. During the 2024 RSV season in Western Australia, 21 922 doses were administered to infants entering their first season and 1221 doses to at-risk children. In this context, the selection and spread of escape variants are a potential concern. This study aimed to investigate nirsevimab binding site mutations using clinical and wastewater data.
Bringing optimised coronavirus disease 2019 (COVID-19) vaccine schedules to immunocompromised populations (BOOST-IC) is a multi-site, adaptive platform trial designed to assess the effect of different booster vaccination schedules in the Australian immunocompromised population on the immunogenicity, safety and cross-protection against COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants.
There is growing evidence to support partial oral antibiotic treatment of severe infections such as Staphylococcus aureus bacteremia, but clinical practice is slow to adopt this paradigm. We know little about how patients with severe infection experience and perceive intravenous and oral antibiotics in terms of quality of life and clinical effectiveness. We performed a qualitative study to elicit patients' views on treatment with intravenous and oral antibiotics, aiming to provide insights that could inform collaborative treatment decision-making.