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Development and validation of a miniaturized bacteriophage host range screening assay against antibiotic resistant Pseudomonas aeruginosa(2)

Development and validation of a miniaturized bacteriophage host range screening assay against antibiotic resistant Pseudomonas aeruginosa

Interchangeability, immunogenicity and safety of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (Synflorix) and 13-valent-PCV (Prevenar13) schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

Aboriginal children living in remote communities are at high risk of early and persistent otitis media. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are primary pathogens. Vaccines with potential to prevent early OM have not been evaluated in this population. We compared immunogenicity (ELISA and opsonophagocytic activity) of a combination of Synflorix™ (PHiD-CV10, 10 serotypes and protein D of NTHi) and Prevenar13™ (PCV13, 10 serotypes plus 3, 6A, and 19A), with recommended schedules.

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. 

Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trial

One third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured.

"i Think i Could Have Used It Better": Experiences of Youth with High HbA1c Commencing Advanced Hybrid Closed-Loop Therapy in a Clinical Trial Setting - A Qualitative Research

Advanced hybrid closed-loop (AHCL) therapy improves glycemia. However, it is not known if there is an improvement in overall outcomes with AHCL for youth with type 1 diabetes (T1D) at high risk of diabetes-related complications. The study aimed to capture the experiences of youth with suboptimal glycemic control when commencing AHCL therapy in a clinical trial setting. 

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)

Respiratory syncytial virus (RSV) is a common, highly contagious virus that causes infections of the lungs and respiratory tract.

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 Compari

We are looking for children and teenagers to take part in an important study investigating the effectiveness of a new combination booster vaccine designed to protect against tetanus, diphtheria, pertussis (whooping cough) and polio.

ATOMIC Ears: A Phase IIB randomised controlled trial to assess safety, tolerability and acceptability of a 5-day Dornase alfa treatment as an adjunct therapy to ventilation tube insertion for otitis media in children

Chris Jennifer Lea-Ann Peter Ruth Brennan-Jones Kent Kirkham Richmond Thornton PhD RN PhD MBBS MRCP(UK) FRACP PhD Head, Ear and Hearing Health

COVALIA (COVid vaccine trial for austrALIA): A phase I, double-blind, dose-ranging, randomised, placebo-controlled trial to study the safety and immunogenicity of a DNA-based vaccine against COVID-19 (COVIGEN) in healthy participants aged 18 to 75 years o

To address the urgent need for a vaccine for COVID-19, BioNet’s gene-based vaccine, COVIGEN, will be investigated in this first-in-human, Phase I study.

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminium in Healthy Third-trimester Pregnant Women; and Safety

Elke Jennifer Peter Seppanen Kent Richmond BSc PhD RN MBBS MRCP(UK) FRACP Program Manager, Bacterial Respiratory Infectious Disease Group Clinical