French biotech company Valneva has started phase 1/2 trials of its potential COVID-19 vaccine across four National Institute for Health Research (NIHR) testing sites in the UK.
The phase 1 and 2 trials will initially test Valneva’s VLA2001 vaccine on 150 volunteers at sites in Birmingham, Bristol, Newcastle and Southampton, with the aim of determining if the vaccine produces a safe and effective immune response against COVID-19.
Valneva’s vaccine candidate is made of inactivated whole virus particles of SARS-CoV-2, which causes COVID-19, with high S-protein density. This is combined with two adjuvants – alum and CpG 1018 – to boost antibody levels.
VLA2001 uses the same manufacturing platform used by Valneva to create its licensed Japanese encephalitis vaccine, Ixiaro.
“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 here in the UK,” he added.
Following the early trial launch, Valneva is expecting the initial primary endpoint read-out two weeks after completion of the two-dose immunisation regimen.
Following the analysis of this data, including the selection of an optimal dose of VLA2001, additional trials are expected to begin in the second quarter of 2021.
The UK government previously pre-ordered 60 million doses of Valneva’s vaccine candidate, with these doses potentially becoming available by the end of 2021.
In August, the government also announced a multi-million-pound joint investment in a manufacturing facility in Livingston, West Lothian to support manufacturing capacity for Valneva’s COVID-19 vaccine.
Following the upfront investment, the expanded Livingston facility could potentially supply up to 100 million doses of VLA2001 to the UK and internationally, according to the Department for Business, Energy & Industrial Strategy.
“While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world, assuming the vaccine is safe and effective,” said Thomas Lingelbach, chief executive officer of Valneva.