French speciality biotech company Valneva has initiated a phase I/II clinical trial of its inactivated and adjuvanted COVID-19 vaccine, VLA2001, in the UK.
The study will be conducted in four study sites across the UK and will also be supported by the National Institute for Health Research (NIHR).
Back in September, Valneva announced a COVID-19 vaccine partnership with the UK government, within which the company agreed to provide the UK with 60 million doses of its vaccine in the second half of 2021, if vaccine development is successful.
The UK government also has an option to secure a further 130 million doses between 2022-2025. In addition, the UK government is investing upfront in the scale up and development of the vaccine.
Valneva expects the primary endpoint read-out to be ready two weeks after completion of the two-dose primary immunisation (day 0,28).
Following analysis of this data, including the selection of the optimal dose currently expected in the early second quarter of 2021, further trials are expected to launch ‘immediately’.
“As we take the monumental steps in rolling out the first COVID-19 vaccine, we must remember that we need to have a range of vaccines available to protect the British public now and long into the future,” said Business Secretary Alok Sharma.
“Today, we have more welcome news that life-saving clinical trials will begin across the country to test the safety and effectiveness of Valneva’s vaccine, which is being clinically developed right here in the UK.
“Having visited Valneva’s state-of-the art facility in the summer, I have seen first-hand the incredible work our scientists and researchers are doing to develop this vaccine. Thanks to significant investment from the UK government, we are doing all we can to ensure our country has the capabilities in place to produce hundreds of millions of doses of this vaccine for the UK, and for those around the world,” he added.