Publications by authors named "M J Koren"
Hantaan virus (HTNV) and Puumala virus (PUUV) are pathogenic zoonoses found in Asia and Europe, respectively. We conducted a randomized Phase 1 clinical trial of individual HTNV and PUUV DNA vaccines targeting the envelope glycoproteins (GnGc), as well as a combined HTNV/PUUV DNA vaccine delivered at varying doses using the PharmaJet Stratis® needle-free injection system (NCT02776761). Cohort 1 and 2 vaccines consisted of 2 mg/vaccination of HTNV or PUUV plasmid, respectively.
View Article and Find Full Text PDFSafety and immunogenicity of a next-generation live-attenuated yellow fever vaccine produced in a Vero cell line in the USA: a phase 1 randomised, observer-blind, active-controlled, dose-ranging clinical trial.
Lancet Infect Dis
December 2024
Background: Recent outbreaks between 2015-17 and production delays have led to a yellow fever vaccine shortage. Therefore, there is an urgent need for new yellow fever vaccines with improved production scalability. A next-generation live-attenuated yellow fever vaccine candidate (vYF), produced in a Vero cell line has shown similar immunogenicity to licensed yellow fever vaccines in preclinical studies.
View Article and Find Full Text PDFBackground: Dengue human infection models (DHIMs) are important tools to down-select dengue vaccine candidates and establish tetravalent efficacy before advanced clinical field trials. We aimed to provide data for the safety and immunogenicity of DHIM and evaluate dengue vaccine efficacy.
Methods: We performed an open-label, phase 1 trial at the University of Maryland (Baltimore, MD, USA).
Article Synopsis
- Study Purpose
- : The research assessed the effectiveness of an "inclisiran first" strategy for patients with atherosclerotic cardiovascular disease who don't reach LDL-C goals, comparing this approach with usual care that only involves statins.
- Key Findings
- : 450 patients were randomized, showing that the "inclisiran first" approach resulted in a 60% reduction in LDL-C, compared to just 7% in usual care. It also helped a higher percentage of patients reach LDL-C targets (<70 mg/dL: 81.8% vs 22.2%).
- Safety and Tolerability
- : While the "inclisiran first" strategy did not lead to increased serious
Article Synopsis
- Lipoprotein(a) is linked to cardiovascular diseases but currently lacks approved treatments, leading to the study of zerlasiran, an RNA treatment aimed at lowering its levels.
- The study evaluated the safety and effects of zerlasiran on lipoprotein(a) levels in healthy individuals and those with stable cardiovascular conditions across several countries.
- Results indicated that zerlasiran significantly reduced lipoprotein(a) concentrations without serious side effects, making it a promising option for treatment.