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Showing results for "clinical trials"

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial

As part of the accelerated development of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we report a dose-finding and adjuvant justification study of SCB-2019, a protein subunit vaccine candidate containing a stabilised trimeric form of the spike (S)-protein (S-Trimer) combined with two different adjuvants.

Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants

A multi-country randomized, placebo-controlled trial of the safety, immunogenicity and efficacy of respiratory syncytial virus (RSV) F-protein nanoparticle vaccine was undertaken in 4,636 pregnant women and their infants. RSV F-protein vaccine was safe and immunogenic in the pregnant women inducing anti-F IgG, palivizumab-competing antibodies and RSV neutralizing antibodies that were transferred to the fetus.

Levels of innate immune factors in preterm and term mothers' breast milk during the 1st month postpartum

Preterm breast milk contains significantly higher concentrations of some immune proteins than term breast milk

Understanding motivation and experience in participating in a paediatric SARS-CoV-2 serosurvey, in Australia

Serosurveys are considered as a valuable tool in estimating population immunity and infection rates but recruitment of children to provide paediatric estimates can be challenging. A novel approach of sampling children undergoing anaesthesia was utilised for a SARS-CoV-2 serosurvey in Australian children and we explore the reasons for participation, feedback on the approach and importance of research into Coronavirus Diseases 2019 (COVID-19).

Nirsevimab binding-site conservation in respiratory syncytial virus fusion glycoprotein worldwide between 1956 and 2021: an analysis of observational study sequencing data

Nirsevimab is an extended half-life monoclonal antibody to the respiratory syncytial virus (RSV) fusion protein that has been developed to protect infants for an entire RSV season. Previous studies have shown that the nirsevimab binding site is highly conserved. However, investigations of the geotemporal evolution of potential escape variants in recent (ie, 2015–2021) RSV seasons have been minimal.

A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED)

Pneumococcal disease (PD) remains a major health concern with considerable morbidity and mortality in children. Currently licensed pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and additional serotypes 22F and 33F. This pivotal phase 3 study compared safety and immunogenicity of V114 and PCV13. 

A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults

No currently licensed and available vaccine has been shown to provide broad protection against endemic MnB disease.

New findings in the pathogenesis of otitis media

This study was the first to concurrently identify middle ear pathogens in both bacterial biofilm and intracellularly in the middle ear mucosa of children and to identify extensive DNA stranding in the MEF from children with AOM

Stakeholders Want a Menu of Choices: Findings from a Consultation Workshop on Improving Access to Secondary Prophylaxis of Rheumatic Fever and Rheumatic Heart Disease

Intramuscular (IM) injection of benzathine benzylpenicillin G (BPG) forms the cornerstone of acute rheumatic fever (ARF) and rheumatic heart disease (RHD) secondary prophylaxis. BPG is available as either a low-cost powdered formulation or a costlier pre-filled suspension. Most of the global RHD burden lies in low- and middle-income countries, which rely on the powdered formulation. 

Multi-million-dollar investment in child health to support vital research

Four The Kids Research Institute Australia researchers have received prestigious fellowships and four significant cohort studies led or co-led by The Kids have received key grants under two new funding programs supported by the State Government’s Future Health Research and Innovation (FHRI) Fund.