Longitudinal Meta-cohort study protocol using systems biology to identify vaccine safety biomarkers

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-07-26 DOI:10.1016/j.vaccine.2025.127504

Joann Diray-Arce , Ana C. Chang , Sara Moradipoor , Donato Amodio , Bruce Carleton , Wan-Chun Chang , Nigel W. Crawford , Meagan Karoly , Annmarie Hoch , Kerry McEnaney , Tahir S. Kafil , Mahitha Donthireddy , Sarah K. Steltz , Simon D. van Haren , Asimenia Angelidou , Kinga K. Smolen , Hanno Steen , Jessica Lasky-Su , Huyen Tran , Peter Liu , Karina A. Top

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引用次数: 0

Abstract

The International Network of Special Immunization Services (INSIS) was established to investigate the causes and risk factors of rare adverse events following immunizations (AEFIs) and develop immunization strategies for mitigating or preventing risk for individuals with prior AEFIs or at risk of AEFIs. INSIS integrates clinical data with multi-omic technologies (e.g., transcriptomics, proteomics, metabolomics) through a global consortium of clinical networks, leading immunology, pharmacogenomics teams to uncover the molecular mechanisms behind AEFIs. The network ensures accurate and standardized data collection and analysis through rigorous data management and quality assurance processes. INSIS also implements harmonized case definitions and protocols for collecting data and samples related to rare AEFIs, such as myocarditis, pericarditis, and Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT) after COVID-19 vaccinations. This protocol outlines the comprehensive approach to enhance risk-benefit assessments of vaccines across populations, identify actionable biomarkers to inform discovery and development of safe vaccines, and support personalized vaccination strategies.

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使用系统生物学鉴定疫苗安全性生物标志物的纵向荟萃队列研究方案

国际特殊免疫服务网络（INSIS）的建立是为了调查免疫接种后罕见不良事件（AEFIs）的原因和危险因素，并制定免疫策略，以减轻或预防已有AEFIs或有AEFIs风险的个体的风险。INSIS通过全球临床网络联盟、领先的免疫学、药物基因组学团队，将临床数据与多组学技术（如转录组学、蛋白质组学、代谢组学）相结合，揭示aefi背后的分子机制。该网络通过严格的数据管理和质量保证流程确保准确和标准化的数据收集和分析。INSIS还实施了统一的病例定义和方案，用于收集与COVID-19疫苗接种后的心肌炎、心包炎和疫苗诱导的免疫性血小板减少症和血栓形成（VITT）等罕见aefi相关的数据和样本。本议定书概述了加强人群疫苗风险-效益评估的综合方法，确定可操作的生物标志物，为安全疫苗的发现和开发提供信息，并支持个性化疫苗接种战略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.