Immune monitoring approaches to clinical studies in immunotherapeutics, vaccines, and gene therapy

Immune monitoring is the quantitative analysis of the magnitude, breadth, and specificity of immune responses and is an essential component of pre-clinical and clinical studies that evaluate vaccines, cancer immunotherapy, gene therapy and immunotherapeutics. Immune monitoring technologies have evolved at a rapid pace in the past decade allowing for high-throughput, multiparameter, functional, and genomic quantitation of cellular, humoral, and innate immune responses. Alongside these technological advances, the growing scale and complexity of clinical trials data demand robust data analysis and logistics strategies, and increasingly leverage big data and artificial intelligence (AI) to manage, integrate, and interpret immune monitoring datasets across multi-site and longitudinal studies. Increasingly, “big-data” immunomics approaches combine bulk high-throughput monitoring with high-resolution single cell-level dissection of immune responses to achieve integrated systems-level analysis. Current approaches to monitor immune responses include long-standing Flow cytometry-, Luminex-, and ELISPOT assays as well as newer platforms such as Meso Scale Discovery (MSD), CyTOF, microfluidics, and transcriptomics just to name a few. Increasingly, immune monitoring approaches are moving toward maximizing data collection from larger study cohorts but with limited availability of individual samples. This requires the use of high-throughput, multifunctional, high-resolution immunoassay approaches and data analysis modalities that can be deployed effectively across highly disparate study priorities. This Research Topic aims to provide a collection of articles that effectively utilize such novel and traditional immune monitoring approaches to diverse clinical and preclinical studies.This collection will feature articles that deploy traditional and emerging immune monitoring technologies in the areas of cancer immunotherapy (including tumor immunology, cancer diagnostics, and cancer therapeutics), gene therapy, infectious disease vaccines, and immunotherapeutics in preclinical and clinical studies. The central focus is on immune monitoring methodologies and their application, rather than on the biology of the disease or target alone.• Immuno-oncology/immunotherapy including CAR-T cell therapy, adoptive cell therapy, and other cellular immunotherapy approaches, with emphasis on immune monitoring of anti-tumor responses.• Gene Therapy: AAV-based gene therapies, target gene-specific immunity, anti-drug antibody (ADA) assays, and immune monitoring strategies to assess vector immunogenicity and transgene-directed immune responses.• Systems and Immunomics approaches: application of Transcriptomics, Proteomics, and Genomics in assessing immunity. • High-throughput, multiparameter immunoassays in bulk and single-cell analysis for evaluating vaccines against infectious diseases and cancer, including cellular technologies such as T-cell and B-cell functional assays.• Review articles that highlight emerging immune monitoring platforms and approaches including integrative ‘-omics” approaches and single-cell high-resolution read outs.• Data analysis, logistics, and AI/big-data approaches for managing, integrating, and interpreting immune monitoring data across multi-site clinical trials.While we welcome traditional multiparameter immunoassay-based studies (Flow cytometry/ELISpot/Luminex etc.) which continue to play an indispensable role in immune monitoring, we also encourage articles that feature newer and emerging technologies and approaches including MSD, CyTOF, microfluidics, next-generation sequencing (NGS), and immunomics/systems-level studies and reviews. Please note that studies focused solely on biomarker discovery without an immune monitoring component, or on tumor microenvironment (TME) spatial profiling as a standalone analysis, fall outside the scope of this Research Topic. Topic editors: Ramu Subbramanian, Reba Kanungo Source: https://www.frontiersin.org/research-topics/83743/immune-monitoring-approaches-to-clinical-studies-in-immunotherapeutics-vaccines-and-gene-therapy