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PERSPECTIVE article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1569251
This article is part of the Research Topic Vaccines and Breakthrough Infections View all 4 articles
Monitoring immunological COVID-19 vaccines clinical testing across the CEPI Centralized Laboratory Network
Provisionally accepted
Lauren Schwartz 1
Jose Vila-Belda1 1 Jerome Carless1 1 Sadish Dhakal 1 Koen Hostyn 1 Trina Gorman 1 Deborah Ogbeni 2 Gathoni Kamuyu 2 Mark Manak 3 Valentina Bernasconi 2
Ali Azizi 2*- 1 Gorman Consulting, Seattle, California, United States
- 2 Coalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway
- 3 3. Turesol Consulting, Florida, United States
The CEPI-Centralized Laboratory Network (CLN) has significantly contributed to the development of several approved SARS-CoV-2 vaccines by conducting over 70,000 clinical samples for testing from various vaccine developers. A centralized data management system was developed to track, review, store and share immunological clinical results generated from sample testing. The data system ensures the completeness and accuracy of submitted results and checks the set criteria in controls for each assay. Each testing facility within the network submits their results to a secure storage system using report forms with embedded data quality checks. Upon submission, a statistical program runs additional checks to identify errors in completeness and uniqueness. Any discrepancies or errors are shared with the testing facility to rectify. Reports are further reviewed by CEPI-CLN experts before releasing to the vaccine developer. Study results are then consolidated into an internal relational database management system, enabling CEPI to analyze the data through an interactive dashboard that visualizes control trends and sample results across all studies. This analysis facilitates the harmonization of immunological data and helps to inform CEPI’s programmatic and strategic decision making. Given the success of this approach with SARS-CoV-2 vaccines, the system will be adopted for new pathogens and assay types currently under development at CEPI-CLN.
Keywords: Vaccine results, data management, quality, Trial monitoring, Vaccine
Received: 31 Jan 2025; Accepted: 18 Mar 2025.
Copyright: © 2025 Schwartz, Vila-Belda1, Carless1, Dhakal, Hostyn, Gorman, Ogbeni, Kamuyu, Manak, Bernasconi and Azizi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Ali Azizi, Coalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.