Results 1 to 10 of about 364,936 (336)

T cell assays for non-clinical immunogenicity risk assessment: best practices recommended by the European Immunogenicity Platform [PDF]

Frontiers in Immunology
In vitro and in silico tools help drug developers reduce unwanted immunogenicity of biologics at the design stage. These include assays that examine different immune system processes leading to anti-drug antibody (ADA) or cytotoxic cellular response ...
Sophie Tourdot, Anette Christine Karle, Marc Rosenbaum, Chloé Ackaert, Pauline Le Vu, Michael Gutknecht, Maryam Ahmadi, Annelies W. Turksma, Timothy P. Hickling   +8 more
doaj   +2 more sources

Associations between genetic variations of HLA and IGHV, vaccination schedule, and COVID-19 vaccine immunogenicity [PDF]

npj Vaccines
Interindividual genetic variations significantly influenced SARS-CoV-2-specific immunogenicity after vaccination, particularly for human leukocyte antigen (HLA) alleles.
Limei Ke, Guoqing Feng, Keyi Lyu, Bo Yin, Wen Fang, Qian Di   +5 more
doaj   +2 more sources

Sleep and vaccine administration time as factors influencing vaccine immunogenicity [PDF]

Kosin Medical Journal, 2022
The immunogenicity of vaccines is affected by host, external, environmental, and vaccine factors; in addition, sleep or circadian rhythms may also have effects.
Eun Seok Kim, Chi Eun Oh
doaj   +1 more source

Orthogonal quantification of soluble inducible T-cell costimulator (ICOS) in healthy and diseased human serum

Journal of Pharmaceutical Analysis, 2022
Inducible T-cell costimulator (ICOS), a homodimeric protein expressed on the surface of activated T-cells, is being investigated as a potential therapeutic target to treat various cancers.
Kevin McKinski, Dean McNulty, Francesca Zappacosta, Mary Birchler, Matt Szapacs, Christopher Evans   +5 more
doaj   +1 more source

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

Frontiers in Medicine, 2022
Cell and Gene Therapy Products (CGT), regulated as Advanced Therapy Medicinal Products (ATMP) in the European Union (EU), represent a novel and varied group of biotherapeutics developed to treat specific conditions for which there are limited or no ...
Laura I. Salazar-Fontana, Laura I. Salazar-Fontana, Laura I. Salazar-Fontana   +2 more
doaj   +1 more source

Human leukocyte antigen class II quantification by targeted mass spectrometry in dendritic-like cell lines and monocyte-derived dendritic cells

Scientific Reports, 2021
The major histocompatibility complex II (HLA-II) facilitates the presentation of antigen-derived peptides to CD4+ T-cells. Antigen presentation is not only affected by peptide processing and intracellular trafficking, but also by mechanisms that govern ...
A. Casasola-LaMacchia, M. S. Ritorto, R. J. Seward, N. Ahyi-Amendah, A. Ciarla, T. P. Hickling, H. Neubert   +6 more
doaj   +1 more source

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

Molecular Therapy: Methods & Clinical Development, 2022
Immunogenicity has imposed a challenge to efficacy and safety evaluation of adeno-associated virus (AAV) vector-based gene therapies. Mild to severe adverse events observed in clinical development have been implicated with host immune responses against ...
Tong-yuan Yang, Manuela Braun, Wibke Lembke, Fraser McBlane, John Kamerud, Stephen DeWall, Edit Tarcsa, Xiaodong Fang, Lena Hofer, Uma Kavita, Vijay V. Upreti, Swati Gupta, LiNa Loo, Alison J. Johnson, Rakesh Kantilal Chandode, Kay-Gunnar Stubenrauch, Maya Vinzing, Cindy Q. Xia, Vibha Jawa   +18 more
doaj   +1 more source

10th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals

mAbs, 2020
Therapeutic proteins and emerging gene and cell-based therapies are attractive therapeutic tools for addressing unmet medical needs or when earlier conventional treatment approaches failed.
S. Tourdot, A. Abdolzade-Bavil, J. Bessa, P. Broët, A. Fogdell-Hahn, M. Giorgi, V. Jawa, K. Kuranda, N. Legrand, S. Pattijn, J. A. Pedras-Vasconcelos, A. Rudy, P. Salmikangas, D. W. Scott, V. Snoeck, N. Smith, S. Spindeldreher, D. Kramer   +17 more
doaj   +1 more source

Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial. [PDF]

, 2014
BACKGROUND: Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of ...
Andersen, Peter, Bang, Peter, Beattie, Trevor, Churchyard, Gavin J., Daubenberger, Claudia, Fielding, Katherine L., Gardiner, Nicolene, Hanekom, Willem A., Hoff, Søren T., Hughes, Elisabeth J., Jeffery, Hannah, Kagina, Benjamin M., Katsoulis, Lynn, Kromann, Ingrid, Landay, Alan, Lenz, Nicole, Mfinanga, Elirehema, Pohl, Christian, Reither, Klaus, Said, Khadija, Scriba, Thomas J.   +20 more
core   +8 more sources

A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration [PDF]

, 2014
Strategies to optimize responses to seasonal influenza vaccination in older adults include the use of adjuvants, higher antigen doses, and intradermal delivery.
Castellino, Flora, Clement, Frédéric, Del Giudice, Giuseppe, Della Cioppa, Giovanni, Galli, Grazia, Groth, Nicola, Leroux-Roels, Geert, Levin, Yotam, Lindert, Kelly, Nicolay, Uwe   +9 more
core   +1 more source