Results 1 to 10 of about 350,984 (342)

Immunogenicity of targeted lentivectors [PDF]

open access: yesOncotarget, 2014
To increase the safety and possibly efficacy of HIV-1 derived lentivectors (LVs) as an anti-cancer vaccine, we recently developed the Nanobody (Nb) display technology to target LVs to antigen presenting cells (APCs).
Adotévi   +67 more
core   +9 more sources

Immunogenicity Risk Assessment of Biotherapeutics Using an Ex Vivo B Cell Assay [PDF]

open access: yesAntibodies
Background/Objectives: Anti-drug antibody (ADA) formation can impact the safety, pharmacokinetics, and/or efficacy of biotherapeutics, including monoclonal antibodies (mAbs).
Kevin M. Budge   +3 more
doaj   +2 more sources

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

open access: yesKosin 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

open access: yesJournal 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   +5 more
doaj   +1 more source

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

open access: yesFrontiers 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   +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

open access: yesScientific 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   +6 more
doaj   +1 more source

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

open access: yesMolecular 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   +18 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]

open access: yes, 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   +20 more
core   +8 more sources

10th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals

open access: yesmAbs, 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   +17 more
doaj   +1 more source

Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2023
Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety.
Linnea C. Franssen   +5 more
doaj   +1 more source

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