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Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents.
Hum Vaccin Immunother
December 2025
Research and Development, Infectious Disease, Moderna, Inc., Cambridge, MA, USA.
Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427).
View Article and Find Full Text PDFBackground: Age-related macular degeneration (AMD), a condition of multifactorial origin, is a major cause of irreversible vision loss in industrialized countries. The dry late stage of the disease, known as geographic atrophy (GA), is characterized by progressive loss of photoreceptor cells and retinal pigment epithelial cells in the central retina. An estimated 300 000 to 550 000 people in Germany suffer from GA.
View Article and Find Full Text PDFThe Splice Index as a prognostic biomarker of strength and function in myotonic dystrophy type 1.
J Clin Invest
January 2025
Center for Inherited Myology Research, Virginia Commonwealth University, Richmond, United States of America.
Background: Myotonic dystrophy type 1 (DM1) is a multisystemic, CTG repeat expansion disorder characterized by a slow, progressive decline in skeletal muscle function. A biomarker correlating RNA mis-splicing, the core pathogenic disease mechanism, and muscle performance is crucial for assessing response to disease-modifying interventions. We evaluated the Myotonic Dystrophy Splice Index (SI), a composite RNA splicing biomarker incorporating 22 disease-specific events, as a potential biomarker of DM1 muscle weakness.
View Article and Find Full Text PDFPopulation Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Multiple Myeloma.
Clin Cancer Res
January 2025
Bristol-Myers Squibb (United States), Summit, New Jersey, United States.
Purpose: Orvacabtagene autoleucel (orva-cel; JCARH125), a CAR T-cell therapy targeting B-cell maturation antigen (BCMA), was evaluated in relapsed/refractory multiple myeloma (RRMM) patients in the EVOLVE phase 1/2 study (NCT03430011). We applied a modified piecewise model to characterize orva-cel transgene kinetics and assessed the impact of various covariates on its pharmacokinetics (PK).
Experimental Design: The population PK analysis included 159 patients from the EVOLVE study.
Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Phys Ther
January 2025
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Importance: Rotator cuff tendinopathy represents the most prevalent cause of shoulder pain, the third most common musculoskeletal disorder after low back pain and knee pain.
Objective: The objective of this study was to determine the effectiveness of corticosteroid injection(s), alone or in combination with anesthetic injection or any other physical therapist interventions, compared to physical therapist interventions alone in adults with rotator cuff tendinopathy.
Design: This study was a systematic review and meta-analysis of randomized controlled trials.
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