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Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

Immunocompromised hosts experience more breakthrough infections and worse clinical outcomes following infection with COVID-19 than immunocompetent people. Prophylactic monoclonal antibody therapies can be challenging to access, and escape variants emerge rapidly. Immunity conferred through vaccination remains a central prevention strategy for COVID-19.

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. 

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.

The AuTOMATIC trial: a multicentre digitally-automated, Bayesian, adaptive, parallel, factorial randomised controlled trial of SMS reminders for childhood vaccination

The estimated effectiveness of SMS (short message service) reminders for improving childhood vaccine coverage and timeliness has varied in previous studies. The observed heterogeneity in effectiveness may be explained in part by variation in reminder content or timing of the reminder relative to the vaccine schedule date. We sought to evaluate the effectiveness of a range of SMS reminders of varied content and timing for improving on-time childhood vaccination.

Projected impacts of climate change on malaria in Africa

The implications of climate change for malaria eradication this century remain poorly resolved. Many studies focus on parasite and vector ecology in isolation, neglecting the interactions between climate, malaria control and the socioeconomic environment, including disruption from extreme weather. Here we integrate 25 years of African data on climate, malaria burden and control, socioeconomic factors, and extreme weather. 

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.

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. 

FeBRILe3: Caregiver Satisfaction With Early Discharge of Febrile Infants Under 3 Months Old

Although evidence supports clinicians to "safely do less" for febrile infants assessed as low risk of serious bacterial infection (SBI), early discharge may increase caregiver concern and reduce satisfaction with care. We captured the self-reported satisfaction and concerns for families enrolled in the study of fever, blood cultures and readiness for discharge in infants less than 3 months old (FeBRILe3), a prospective safety assessment of early discharge of low-risk febrile infants, to aid evaluation of this practice. 

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.

Systemic antibiotics for chronic suppurative otitis media

Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Systemic antibiotics are commonly used to treat people with CSOM. This is the first update to the review published in 2021, and is one of a suite of seven Cochrane reviews evaluating the effects of non-surgical interventions for CSOM.