ArticleGene therapy2022
Validation of an IFN-gamma ELISpot assay to measure cellular immune responses against viral antigens in non-human primates.
Article in Gene therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Antiviral Agents for Preventing Cytomegalovirus Disease in Recipients of Hematopoietic Cell Transplantation.Viruses · 2024Pooled it
- 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.Human vaccines & immunotherapeutics · 2026Article
- Evaluating varicella-zoster virus vaccine immunogenicity through Fc-mediated antibody functions: the roles of ADCP and ADCC.NPJ vaccines · 2026Article
- Effect of Different Adjuvants on the Immunogenicity of a Recombinant Herpes Zoster Vaccine in Mice, Rats and Non-Human Primates.Vaccines · 2025Article
- Advances in Therapeutic Cancer Vaccines, Their Obstacles, and Prospects Toward Tumor Immunotherapy.Molecular biotechnology · 2025Review
- Endoplasmic Reticulum-Targeted Phototherapy Remodels the Tumor Immunopeptidome to Enhance Immunogenic Cell Death and Adaptive Anti-Tumor Immunity.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Validation of an interferon-gamma enzyme-linked immunosorbent spot assay to evaluate cell-mediated immunity against severe acute respiratory syndrome coronavirus 2.Human vaccines & immunotherapeutics · 2024Article
- A review of CD4Veterinary immunology and immunopathology · 2024Review
- Lack of memory recall in human CD4 T cells elicited by the first encounter with SARS-CoV-2.iScience · 2024Article
- Polyfunctional T cells and unique cytokine clusters imprint the anti rAAV2/rAAV9 vector immune response.Frontiers in immunology · 2024Article
- Development of dendritic cell loaded MAGE-A2 long peptide; a potential target for tumor-specific T cell-mediated prostate cancer immunotherapy.Cancer cell international · 2023Article
- Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.The AAPS journal · 2023Review
- Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.Molecular therapy. Methods & clinical development · 2022Review
- RETRACTED: Glycine Nano-Selenium Enhances Immunoglobulin and Cytokine Production in Mice Immunized with H9N2 Avian Influenza Virus Vaccine.International journal of molecular sciences · 2022Article
- Differential T cell immune responses to deamidated adeno-associated virus vector.Molecular therapy. Methods & clinical development · 2022Article
- Harmonization and qualification of an IFN-γ Enzyme-Linked ImmunoSpot assay (ELISPOT) to measure influenza-specific cell-mediated immunity within the FLUCOP consortium.Frontiers in immunology · 2022Article
- AAV-mediated gene therapy for galactosialidosis: A long-term safety and efficacy study.Molecular therapy. Methods & clinical development · 2021Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adeno-Associated Virus (AAV)-based gene therapy vectors are in development for many inherited human disorders. In nonclinical studies, cellular immune responses mediated by cytotoxic T cells may target vector-transduced cells, which could impact safety and efficacy. Here, we describe the bioanalytical validation of an interferon-gamma (IFN-γ)-based Enzyme-Linked Immunospot (ELISpot) assay for measuring T cell responses against viral antigens in cynomolgus monkeys. Since ELISpots performed with antigen-derived peptides offer a universal assay format, method performance characteristics were validated using widely available peripheral blood mononuclear cells (PBMCs) responsive to cytomegalovirus peptides. The limit of detection and confirmatory cut point were established using statistical methods; precision, specificity, and linearity were confirmed. Monkey PBMCs from an AAV5 gene therapy study were then analyzed, using peptide pools spanning the vector capsid and transgene product. AAV5-specific T cell responses were detected only in 2 of 18 monkeys at Day 28, but not at Day 13 and 56 after vector administration, with no correlation to liver enzyme elevations or transgene expression levels. No transgene product-specific T cell responses occurred. In conclusion, while viral peptide-specific IFN-γ ELISpots can be successfully validated for monkey PBMCs, monitoring peripheral T cell responses in non-clinical AAV5 gene therapy studies was of limited value to interpret safety or efficacy.
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