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Seasonal influenza vaccine effectiveness is low. Carbohydrate fatty acid monosulphate ester (CMS), a new oil-in-water adjuvant, has proven potency in animal models with suggested capacity for dose-sparing. The objective was to evaluate safety and immunogenicity of CMS when added to a low-dose influenza vaccine (QIV) in humans. In a randomised, double-blind, active-controlled, first-in-human study, sixty participants (18-50 years) received either 0.5 mg CMS or 2 mg CMS with 1/5th dose QIV, or a full dose QIV without CMS. Adverse events (AE) were monitored until 7 days post-vaccination. Haemagglutinin inhibition (HI) titres in serum and CD4+ T cells in PBMCs were determined at day 0, 7, 28, and 180. Mean age was 37.6 (±10.1) years and 42/60 (70.0%) were female. Pain at injection site (42/60, 86.7%) and headache (34/60, 56.7%) were reported most and more frequently in the 2 mg CMS group. HI titres and the frequency of influenza specific CD4+ T cells were equal across strains for the three cohorts on all visits, increased until day 28 and decreased at day 180 to values higher than baseline. CMS was safe in humans. Humoral and cell-mediated immunogenicity was similar across vaccines, even with 1/5th antigen dose. CMS can have beneficial implications in low-resource settings or in a pandemic context.

This article introduces an analytical framework that interprets individual measures of entropy-based mobility derived from mobile phone data. We explore and analyze two widely recognized entropy metrics: random entropy and uncorrelated Shannon entropy. These metrics are estimated through collective variables of human mobility, including movement trends and population density. By employing a collisional model, we establish statistical relationships between entropy measures and mobility variables. Furthermore, our research addresses three primary objectives: firstly, validating the model; secondly, exploring correlations between aggregated mobility and entropy measures in comparison to five economic indicators; and finally, demonstrating the utility of entropy measures. Specifically, we provide an effective population density estimate that offers a more realistic understanding of social interactions. This estimation takes into account both movement regularities and intensity, utilizing real-time data analysis conducted during the peak period of the COVID-19 pandemic.

The Enzyme-Linked ImmunoSpot (ELISpot) assay detects cytokines secreted during T cell-specific immune responses against pathogens. As this assay has acquired importance in the clinical setting, standard bioanalytical evaluation of this method is required. Here, we describe a formal bioanalytical validation of a double-color ELISpot assay for the evaluation of IFN-γ and IL-4 released by T helper 1 and T helper 2 cells, respectively. As recommended by international guidelines, the parameters assessed were: range and detection limits (limit of detection, LOD; upper and lower limit of quantification, ULOQ and LLOQ), Linearity, Relative Accuracy, Repeatability, Intermediate Precision, Specificity and Robustness. The results obtained in this validation study demonstrate that this assay meets the established acceptability criteria. ELISpot is therefore a reliable technique for measuring T cell-specific immune responses against various antigens of interest., Competing Interests: Declaration of Competing Interest FD, DDT, CM, PP, CS, GF, IF, FV, IR, GP, MM and AM are employed by VisMederi Srl; EM is founder and Chief Scientific Officer of VisMederi Srl and VisMederi Research Srl; IM is employed by University of Siena., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)