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A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix Vaccine When Given to Healthy Infants at 3 and 12 Months of Age.
Infect Dis Ther
January 2025
Vaccine Research and Development, Pfizer R&D UK Ltd, Marlow, UK.
Introduction: Infants and young children typically have the highest age-related risk of invasive meningococcal disease. The immunogenicity and safety of a single primary dose and a booster of a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix) in infants were evaluated.
Methods: In this phase 3b, open-label, single-arm study, healthy 3-month-old infants received a single Nimenrix dose followed by a booster at age 12 months (1 + 1 series).
Therapeutic gene correction of HBB frameshift CD41-42 (-TCTT) deletion in human hematopoietic stem cells.
Adv Biotechnol (Singap)
January 2025
MOE Key Laboratory of Gene Function and Regulation, State Key Laboratory of Biocontrol, School of Life Sciences, Sun Yat-Sen University, Guangzhou, 510275, Guangdong, China.
Β-thalassemia is one of the global health burdens. The CD41-42 (-TCTT) mutation at HBB is the most prevalent pathogenic mutation of β-thalassemia in both China and Southeast Asia. Previous studies focused on repairing the HBB CD41-42 (-TCTT) mutation in β-thalassemia patient-specific induced pluripotent stem cells, which were subsequently differentiated into hematopoietic stem and progenitor cells (HSPCs) for transplantation.
View Article and Find Full Text PDFEffectiveness and Safety in Patients with Non-Valvular Atrial Fibrillation Who Switched from Warfarin to Direct Oral Anticoagulants in Medicare Population.
Adv Ther
January 2025
Department of Hospital Medicine, Ochsner Health System, New Orleans, LA, 70121, USA.
Introduction: Atrial fibrillation (AF), a common heart rhythm abnormality, is linked to a higher risk of stroke. Traditionally, warfarin has been the primary anticoagulation treatment for reducing the stroke risk. The new standard of treatment by direct oral anticoagulants (DOACs) offers greater benefits including improved efficacy and fewer adverse effects with reduced monitoring.
View Article and Find Full Text PDFAntiplatelet Agents in Endovascular Neurointerventional Procedures.
J Neurosurg Anesthesiol
January 2025
Department of Neurology, Neurocritical Care Division, University of Pennsylvania, Philadelphia, PA.
Minimally invasive, image-guided endovascular procedures are becoming increasingly prevalent as techniques and technologies have advanced, particularly within the realm of neurovascular interventions. Endovascular approaches ubiquitously result in endothelial injury with subsequent risk of thromboembolic complications. Periprocedural antiplatelet agent use is an integral component of the management of patients undergoing endovascular neurointerventional procedures.
View Article and Find Full Text PDFCharacterizing Antisense Oligonucleotide-Induced Histopathology Findings in Spinal Cord of Mauritius Cynomolgus Monkeys by Molecular Localization Investigation.
Toxicol Pathol
January 2025
Novartis Institute for Biomedical Research, Cambridge, Massachusetts, USA.
The safety of a 2'--methoxyethyl antisense oligonucleotide (ASO) was investigated in Mauritius cynomolgus monkeys in a 41-week Good Laboratory Practice (GLP) toxicity study after multiple intrathecal (IT) administrations. Histopathological examination revealed ectopic formation of lymphoid follicles in the spinal cord (SC) at the injection site at all doses and the presence of granular material in neurons of the SC in high-dose animals. The granular material was seen in all the segments of the SC, but mainly in the lumbar segment and persisted at the end of the 26-week recovery period, while the lymphoid follicles showed a reversibility trend.
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