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

Publication date: Jul 26, 2025

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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Concepts Keywords
Accurate Adversomics
Covid AEFI
Immunology Biomarker discovery
Pharmacogenomics COVID-19 vaccines
Transcriptomics INSIS
Multi-omics
Myocarditis
Pericarditis
PF4
Systems biology
TTS
Vaccine safety
VITT

Semantics

Type Source Name
disease MESH causes
disease IDO quality
disease MESH myocarditis
disease MESH pericarditis
disease MESH Immune Thrombocytopenia
disease MESH Thrombosis
disease MESH COVID-19
drug DRUGBANK Albendazole
disease MESH Thrombocytopenia
disease MESH Syndrome
disease MESH Guillain Barre Syndrome
drug DRUGBANK Heparin
disease MESH Major Adverse Cardiac Events
disease MESH Left Ventricular Dysfunction
disease IDO blood
disease MESH Middle East Respiratory Syndrome
disease IDO country
disease MESH Emergency
disease IDO assay
pathway REACTOME Translation
disease MESH Histocompatibility
drug DRUGBANK Corticorelin
drug DRUGBANK Coenzyme M
pathway KEGG Influenza A
disease MESH monkey pox
disease MESH smallpox
pathway KEGG Platelet activation
disease MESH death
disease MESH influenza
disease MESH Lassa fever
disease IDO replication
disease MESH cancer
disease MESH allergy
disease IDO history
disease IDO symptom
disease IDO site
drug DRUGBANK Nitrogen
drug DRUGBANK Tretamine

Original Article

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