Title : Developing a network: supporting SARS-CoV-2 assays vaccine clinical trials through the CEPI Centralized Laboratory Network.
Abstract:
The UK Health Security Agency (UKHSA) has longstanding expertise in the technological support of vaccine development through a vast array of immunological assays. In early 2020, using this valuable knowledge, scientists within UKHSA were able to rapidly develop a live virus microneutralisation assay (WT-MNA) that could be used in a high throughput setting to support the development of the SARS-CoV-2 vaccines. At the same time, the Coalition for Epidemic Preparedness Innovations (CEPI) issued a call to establish a global network of well-qualified laboratories to centralize immunological laboratory assessment of vaccine candidates. The UKHSA partnered with CEPI and other laboratories, such as Q2 Nexelis, to form the CEPI Centralized Laboratory Network (CLN). The CLN shares assays for quantitation of anti-COVID-19 activity including antibody binding and neutralization, pseudo virus neutralization and cell mediated immunity to eight participating laboratories around the world, with additional laboratories coming online in 2023. The CEPI Centralized Laboratory Network (CLN) is the first and largest global group launched to harmonize the assessment of COVID-19 vaccines for support of preclinical and clinical trials.
The CEPI CLN program has successfully provided clinical trial support to over 50 developers and tested over 70,000 samples to date. This coordinated laboratory analysis for the assessment of immune responses to vaccines provides a blueprint for how the network can support the CEPI 100-day mission to develop a vaccine and prepare for Disease Z. Critical evaluation of the successes and challenges in forming the CEPI CLN will aid in preparedness for the next pandemic.
Audience Take Away:
- Understand the role of the UKHSA in the development of the CEPI Centralized Laboratory Network.
- Demonstration of the power of the network in supporting the development of vaccines during the COVID-19 pandemic and beyond.
- A look to the future with what lessons can be learnt from this pandemic to the next, how these can be addressed and used to be prepared for Disease Z.
