Longitudinal Meta-cohort study protocol using systems biology to identify vaccine safety biomarkers
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.
Authors
- Joann Diray‐Arce (ORCID: https://orcid.org/0000-0003-2183-4269)
- Hanno Steen (ORCID: https://orcid.org/0000-0003-0179-6648)
- Kerry McEnaney (ORCID: https://orcid.org/0000-0002-0378-3456)
- Jessica Ann Lasky-Su (ORCID: https://orcid.org/0000-0001-6236-4705)
- Asimenia Angelidou (ORCID: https://orcid.org/0000-0002-6716-6561)
- Annmarie Hoch (ORCID: https://orcid.org/0000-0003-0836-2164)
- Nigel W. Crawford (ORCID: https://orcid.org/0000-0003-1851-5080)
- Sara Moradipoor (ORCID: https://orcid.org/0000-0002-1445-9088)
- Inna G. Ovsyannikova (ORCID: https://orcid.org/0000-0003-1506-9214)
- Simon D. van Haren (ORCID: https://orcid.org/0000-0002-1791-0161)
- Richard B. Kennedy
- Ana C. Chang (ORCID: https://orcid.org/0000-0002-3787-4719)
- Kinga K. Smolen (ORCID: https://orcid.org/0000-0001-8650-3693)
- Tahir S Kafil
- Helen Petousis‐Harris (ORCID: https://orcid.org/0000-0001-6098-8610)
- Bruce Carleton (ORCID: https://orcid.org/0000-0002-4485-4054)
- Rae S. M. Yeung (ORCID: https://orcid.org/0000-0003-2361-725X)
- Donato Amodio (ORCID: https://orcid.org/0000-0003-4550-3018)
- Dale Nordenberg
- Sarah K. Steltz
- Gregory A. Poland (ORCID: https://orcid.org/0000-0001-5057-4457)
- Nicholas William Wood (ORCID: https://orcid.org/0000-0002-9500-3348)
- C. Buddy Creech (ORCID: https://orcid.org/0000-0002-8276-9053)
- Ofer Levy (ORCID: https://orcid.org/0000-0002-5859-1945)
- Steve Black (ORCID: https://orcid.org/0000-0002-9504-7981)
- Sonali Kochhar (ORCID: https://orcid.org/0000-0002-1150-5691)
- Al Ozonoff (ORCID: https://orcid.org/0000-0003-4233-5899)
- Ishac Nazy (ORCID: https://orcid.org/0000-0002-5695-4343)
- Clare Cutland (ORCID: https://orcid.org/0000-0001-8250-8307)
- Karina A. Top (ORCID: https://orcid.org/0000-0002-9981-368X)
- Huyen Tran (ORCID: https://orcid.org/0000-0003-1989-959X)
- Robert T. Chen (ORCID: https://orcid.org/0000-0002-3094-8367)
- Peter Liu (ORCID: https://orcid.org/0000-0002-8703-6967)
- Wan‐Chun Chang (ORCID: https://orcid.org/0000-0001-7069-7083)
- Paolo Palma
- Meagan Karoly
- Mahitha Donthireddy
Institutions
- Broad Institute (US)
- Brigham and Women's Hospital (US)
- Boston Children's Hospital (US)
- The University of Sydney (AU)
- Beth Israel Deaconess Medical Center (US)
- University of Ottawa (CA)
- University of Alberta (CA)
- University of Toronto (CA)
- University of the Witwatersrand (ZA)
- Hospital for Sick Children (CA)
- Auckland University of Technology (NZ)
- Bambino Gesù Children's Hospital (IT)
- Mayo Clinic in Arizona (US)
- The Task Force for Global Health (US)
- Women and Children’s Health Research Institute (CA)
- Healthcare Global Enterprises (IN)
- Mayo Clinic in Florida (US)
- Murdoch Children's Research Institute (AU)
- BC Children's Hospital (CA)
- Monash University (AU)
- Vanderbilt University Medical Center (US)
- McMaster University (CA)
Publication Details
- Journal
- Vaccine
- Published
- 2025-07-26
- DOI
- https://doi.org/10.1016/j.vaccine.2025.127504
- Citations
- 2
- Primary Topic
- vaccines and immunoinformatics approaches
- Type
- article
- Field-Weighted Citation Impact
- 1.61