Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities. [PDF]
Carone M +4 more
europepmc +1 more source
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh +19 more
wiley +1 more source
Porcine Parvovirus virus-like particle vaccine induces long-term humoral immunity by recruiting T follicular helper and germinal center B cell responses. [PDF]
Hao C +12 more
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Spermidine Mitigates Immune Cell Senescence and Boosts Vaccine Responses in Healthy Older Adults-A Pilot Study. [PDF]
Alsaleh G +25 more
europepmc +1 more source
Abstract In this paper, we explore how neurodivergent ways of being in early education are often gendered. The intersectionalities of gender and neurodivergence often lead to fixed expectations that perpetuate binary interpretations, pathologisations, missed diagnoses and a lack of curated support.
Ruth Churchill Dower, Hannah Hogarth
wiley +1 more source
Development of a unified mass cytometry assay integrating activation-induced markers (AIMs) and cytokine profiling for high-throughput assessment of antigen-specific T cell responses. [PDF]
Wan N +10 more
europepmc +1 more source
What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?
Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady +6 more
wiley +1 more source
T-cell responses to primary SARS-CoV-2 vaccination in Down syndrome - From childhood to adulthood. [PDF]
Hensen LCM +7 more
europepmc +1 more source

