Publications by authors named "A Marcel Willemsen"

Health Technology Assessment (HTA) in Europe has undergone significant evolution, culminating in the adoption of Regulation (EU) 2021/2282 on HTA (HTAR) aimed at fostering sustainable collaboration in HTA at the European Union (EU) level. The EUnetHTA 21 project, a 2-year initiative, was commissioned to address key methodological issues and prepare for the implementation of the HTAR. This commentary documents the outcomes of the EUnetHTA 21 project, focusing on Joint Clinical Assessments (JCAs), while analyzing challenges encountered and lessons learned for future collaboration under the HTAR.

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Article Synopsis
  • The study evaluates a new meningococcal vaccine (MenABCWY) that combines components of the existing MenB vaccine (4CMenB) and the MenACWY vaccine, aiming to provide broad immunization against various meningococcal strains and ease vaccination schedules.
  • Conducted as a phase 3 randomized trial across multiple countries, healthy participants aged 10-25 were assigned to receive different vaccine schedules to assess safety, immune response, and consistency of vaccine lots.
  • The trial primarily focused on the immune response to MenB strains, comparing MenABCWY's effectiveness to 4CMenB and evaluating the consistency of immune responses among different production lots of the vaccines.
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Background: Managing risk effectively within small animal veterinary practice is integral for staff, patient and client safety. Veterinary personnel are exposed to many risks, including bites, scratches, sharps injuries and exposure to zoonotic diseases and multi-resistant organisms. Patients may also be exposed to healthcare-associated infections, including multi-resistant organisms.

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Background: Meningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0-2, 0-6, or 0-2-6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.

Methods: In a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0-6 schedule), 4CMenB (0-2-6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine.

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Purpose: Homozygous pathogenic variants in the CYP17A1 gene result in defective activity of the steroidogenic enzymes 17α-hydroxylase/17,20-lyase resulting in the clinical syndrome 17-OHD characterised by hypertension, hypokalaemia, and disorders of sexual development. Pathogenic variants of CYP17A1 lead to complete or partial loss of enzymatic activity and clinical presentations of varying severity. This study aimed to examine relationships between CYP17A1 genotype and clinical presentation in a global cohort.

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