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Research
Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trialBacille Calmette-Guérin (BCG) vaccination has off-target (non-specific) effects that are associated with protection against unrelated infections and decreased all-cause mortality in infants. We aimed to determine whether BCG vaccination prevents febrile and respiratory infections in adults.
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Long-term follow-up after recurrent otitis media and ventilation tube insertion: Hearing outcomes and middle-ear health at six years of ageTo investigate the long-term impact of recurrent otitis media (rOM) and ventilation tube insertion (VTI) in early childhood on hearing outcomes and middle-ear health three to five years later, in a prospective pregnancy cohort study.
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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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Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathyThe reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy.
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Development of an International Database for a Rare Genetic Disorder: The MECP2 Duplication Database (MDBase)The natural history of MECP2 duplication syndrome (MDS), a rare X-linked neurodevelopmental disorder with an estimated birth prevalence of 1/150,000 live births, is poorly understood due to a lack of clinical data collected for research. Such information is critical to the understanding of disease progression, therapeutic endpoints and outcome measures for clinical trials, as well as the development of therapies and orphan products.
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A phase 3, randomized, double-blinded, placebo-controlled trial toevaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy (Matisse)Peter Richmond MBBS MRCP(UK) FRACP Head, Vaccine Trials Group Head, Vaccine Trials Group Professor Peter Richmond is Head of the Vaccine Trials Group
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A Phase I/II, Multicentre, Observer-blinded, Randomized, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) in CompariJennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical
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BCG vaccination to Reduce the impact of COVID-19 in Australian healthcare workers following Coronavirus Exposure (BRACE) TrialJennifer Peter Kent Richmond RN MBBS MRCP(UK) FRACP Clinical Research Manager Head, Vaccine Trials Group Jennifer.Kent@thekids.org.au Clinical
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A Phase 3, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate Safety, Tolerability, and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Allogeneic Hematopoietic Cell Transplant Recipients (PNEU-STEM)Individuals who receive allogeneic hematopoietic cell transplant (allo-HCT) are immunocompromised and at high risk of pneumococcal infections, especially in the months following transplant. This study evaluated the safety and immunogenicity of V114 (VAXNEUVANCE; Merck, Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), a 15-valent pneumococcal conjugate vaccine (PCV), when given to allo-HCT recipients.
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Pneumococcal Conjugate Vaccines Are Protective Against Respiratory Syncytial Virus Hospitalizations in Infants: A Population-Based Observational StudyPneumococcal conjugate vaccines (PCV) reduced the risk of respiratory syncytial virus (RSV) in a randomized clinical trial. We aimed to assess the real-world effectiveness of PCV on RSV-hospitalizations among Western Australian infants.