Influenza and its complications account for substantial morbidity and mortality, especially among the elderly. In young adults, immunization provides 70-90% protection, while among the elderly the vaccine may be only
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Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.
Methods: In this phase 3 study (NCT04707391), healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of MenABCWY 1 month post-vaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety.
Protein aggregation in the frozen state induced by dropping stress.
Eur J Pharm Sci
December 2024
Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan; Exploratory Research Center on Life and Living Systems, National Institutes of Natural Sciences, 5-1 Higashiyama, Myodaiji, Okazaki, Aichi 444-8787, Japan. Electronic address:
The formation of protein aggregates, which can be immunogenic and lower the efficacy and safety of protein drugs, has been an issue in biopharmaceutical development for more than a decade. Although protein drugs are often shipped as frozen material, the effect of the accidental dropping of frozen proteins, which can occur during shipping and handling, on the physical stability has not been studied. Here, a frozen Fc fusion protein was subjected to dropping stress and the increase in the aggregate concentration was evaluated.
View Article and Find Full Text PDFLaboratory safety and immunogenicity evaluation of live attenuated avian infectious bronchitis GI-23 virus vaccine.
Vaccine
December 2024
Poultry Diseases Department, Faculty of Veterinary Medicine, Beni-Suef University, Beni-Suef 62511, Egypt.
Avian infectious bronchitis virus (IBV) is responsible for a highly contagious disease that poses a significant threat to the poultry industry due to its high rates of evolution. The occurrence of vaccination failure can frequently be attributed to the emergence of novel strains that exhibit antigenic divergence from conventional vaccine strains. This study aims to evaluate the safety and efficacy of the Eg/1212B-based live attenuated virus vaccine indicated for immunization of chickens against nephropathogenic GI-23 variant strains reported globally.
View Article and Find Full Text PDFIs duchenne gene therapy a suitable treatment despite its immunogenic class effect?
Expert Opin Drug Saf
December 2024
Medical Genetics 8812, University of Alberta, Edmonton, AB, Canada.
Introduction: Duchenne muscular dystrophy (DMD) is a severe X-linked disorder characterized by progressive muscle weakness and eventual death due to cardiomyopathy or respiratory complications. Currently, there is no cure for DMD, with standard treatments primarily focusing on symptom management. Using immunosuppressive measures and optimized vector designs allow for gene therapies to better address the underlying genetic cause of the disease.
View Article and Find Full Text PDFImmunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged ≥18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial.
Expert Rev Vaccines
December 2024
Guangzhou Patronus Biotech Co, Ltd, Guangzhou, China.
Background: LYB001 is a recombinant protein COVID-19 vaccine displaying a receptor-binding domain (RBD) in a highly immunogenic array on virus-like particles (VLPs). This study assessed the immunogenicity and safety of LYB001 as a booster.
Research Design And Methods: In this randomized, active-controlled, double-blinded, phase 3 trial, participants aged ≥18 years received a booster with LYB001 or ZF2001 (Recombinant COVID-19 Vaccine).
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