Naobios, Nuvonis and the European Vaccine Initiative (EVI) have announced a joint effort with the Inno4Vac consortium to develop an influenza A(H3N2) Human Viral Challenge Agent with the long-term goal of addressing the low effectiveness of seasonal influenza vaccines when fighting influenza A(H3N2).
To address the ongoing need for more rapid and efficient vaccine development, the Inno4Vac consortium, a public-private partnership coordinated by EVI, is advancing the development of an innovative Controlled Human Infection Model (CHIM) for influenza A(H3N2).
Controlled Human Infection Models involve the deliberate, safe exposure of healthy adult volunteers to a well-characterised virus under tightly controlled clinical conditions, enabling the fast generation of data on vaccine protection, immunogenicity and immune responses.
A critical prerequisite for such studies is the availability of a robust, GMP-compliant Human Viral Challenge agent.
For this project, Naobios will leverage Nuvonis’s well-characterised GMP Vero Working Cell Bank.
This approach eliminates the need for time-consuming cell bank development and enables Naobios to proceed directly to GMP production of the Human Viral Challenge Agent using a fully tested, regulatory compliant cell substrate manufactured to industrial standards.
Vero cells are widely accepted by national and international regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and are used in commercial vaccine production.
"Nuvonis is thrilled to partner with Naobios and EVI on this groundbreaking project to develop an influenza A(H3N2) Human Viral Challenge Agent,” said Christina Nicolodi, CEO of Nuvonis.
“We are pleased to collaborate with Naobios on this influenza challenge agent and to leverage Nuvonis’s high-performance Vero cell bank. This is an important step towards the success of the Inno4Vac project,” said Ole Olesen, Executive Director of EVI.
“As an EVI partner and Inno4Vac consortium member, we encourage collaboration and expertise from leading experts to address scientific bottlenecks in vaccine development."
"Together with Naobios and Nuvonis, we believe Inno4Vac can now progress the development of a high-quality controlled influenza virus infection model with confidence,” said Othmar Engelhardt, Head of Seasonal Influenza, Research & Development, Medicines and Healthcare products Regulatory Agency (MHRA), UK, and member of the Inno4Vac consortium.