The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.
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http://dx.doi.org/10.1038/s41591-021-01527-y | DOI Listing |
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.
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 PDFVaccine
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 PDFExpert 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 PDFExpert 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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