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Bringing optimised COVID-19 vaccine schedules to immunocompromised populations: statistical elements and design

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. 

Population pharmacokinetics of penicillin G: insights into increased clearance at low concentrations to guide development of improved long-acting formulations for syphilis

Although benzylpenicillin (penicillin G) is listed by the World Health Organization as an Essential Medicine, dose optimization is a persistent challenge, especially for long-acting intramuscular formulations. Maintaining sustained antibiotic exposure at target concentrations is crucial for secondary chemoprophylaxis of rheumatic heart disease and treatment of syphilis. 

Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol

Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The 'Blow, Breathe, Cough' (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.

BEAT-CF (Bayesian Evidence Adaptive Treatment for people with Cystic Fibrosis): description of a prospective cohort for nested studies in cystic fibrosis

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.

Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study

Community perception of vaccine safety influences vaccine uptake. Our objective was to assess current vaccine safety monitoring by examining factors that may influence the availability of post-vaccination survey data, and thereby the specificity and sensitivity of existing signal detection methods.

Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia

Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023. 

Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol

Staphylococcus aureus bloodstream infection is traditionally treated with at least 2 weeks of intravenous antibiotics in adults, 3-7 days in children, and often longer for those with complicated disease. The current practice of treating S. aureus bacteremia with prolonged IV antibiotics (rather than oral antibiotics) is based on historical observational research and expert opinion. Prolonged IV antibiotic therapy has significant disadvantages for patients and healthcare systems, and there is growing interest in whether a switch to oral antibiotics following an initial period of IV therapy is a safe alternative for clinically stable patients.

Prevention of rheumatic heart disease in New Zealand: High-dose subcutaneous benzathine penicillin is cost-saving compared with traditional intramuscular injections

Acute rheumatic fever is a preventable condition that can lead to chronic illness and early death. Standard prevention with 4-weekly intramuscular (IM) benzathine penicillin G (BPG) injections for ≥10 years may be associated with poor adherence. High-dose 10-weekly subcutaneous penicillin injections (SCIP) may improve adherence by reducing injection frequency.

Inferring temporal trends of multiple pathogens, variants, subtypes or serotypes from routine surveillance data

Estimating the temporal trends in infectious disease activity is crucial for monitoring disease spread and the impact of interventions. Surveillance indicators routinely collected to monitor these trends are often a composite of multiple pathogens. For example, "influenza-like illness"-routinely monitored as a proxy for influenza infections-is a symptom definition that could be caused by a wide range of pathogens, including multiple subtypes of influenza, SARS-CoV-2, and RSV.

Immunogenicity, reactogenicity, and IgE-mediated immune responses of a mixed whole-cell and acellular pertussis vaccine schedule in Australian infants: A randomised, double-blind, noninferiority trial

In many countries, infant vaccination with acellular pertussis (aP) vaccines has replaced use of more reactogenic whole-cell pertussis (wP) vaccines. Based on immunological and epidemiological evidence, we hypothesised that substituting the first aP dose in the routine vaccination schedule with wP vaccine might protect against IgE-mediated food allergy. We aimed to compare reactogenicity, immunogenicity, and IgE-mediated responses of a mixed wP/aP primary schedule versus the standard aP-only schedule.