Development of Real-Time Surveillance for Serious Adverse Events in a Pragmatic Clinical Trial Using National Registers in Finland.

Purpose: We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.

Patients And Methods: The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine.

A randomized controlled add-on trial of fluoxetine and cognitive behavioral therapy for help-seeking men with a sexual interest in children: presentation of the PARACHUTES trial protocol and initial feasibility data.

Background: Sexual Interest in Children (SIC) is a major risk factor for sexual offending, yet clinical trials are sparse. The present protocol outlines a randomized controlled trial (RCT) that aims to investigate the effectiveness of fluoxetine and Cognitive Behavioral Therapy (CBT) in help-seeking men with SIC.

Methods: Adult men contacting the Swedish telephone helpline PrevenTell are screened for inclusion and invited to further assessment on site.

Protocol to study early lung developmental branching in mouse embryos using explant culture.

Mouse lung branching morphogenesis creates epithelial tree structures required for respiration. Here, we present a protocol for studying mouse lung developmental branching using lung explant cultures. We describe steps for isolating lungs with a video at embryonic day 12.

Pathogenic and Apathogenic Strains of Lymphocytic Choriomeningitis Virus Have Distinct Entry and Innate Immune Activation Pathways.

Lymphocytic choriomeningitis virus (LCMV) and Lassa virus (LASV) share many genetic and biological features including subtle differences between pathogenic and apathogenic strains. Despite remarkable genetic similarity, the viscerotropic WE strain of LCMV causes a fatal LASV fever-like hepatitis in non-human primates (NHPs) while the mouse-adapted Armstrong (ARM) strain of LCMV is deeply attenuated in NHPs and can vaccinate against LCMV-WE challenge. Here, we demonstrate that internalization of WE is more sensitive to the depletion of membrane cholesterol than ARM infection while ARM infection is more reliant on endosomal acidification.