Valneva announced yesterday that a phase 3 trial will compare its COVID-19 vaccine candidate to AstraZeneca’s jab, which is conditionally approved in the EU under the brand name Vaxzevria.
The phase 3 trial of Valneva’s vaccine candidate – VLA2001 – against Vaxzevria will see approximately 4,000 participants receive two doses of either vaccine.
Researchers will then determine the immune response two weeks after the completion of a two-dose immunisation scheduled, administered four weeks apart.
The trial, conducted in the UK with support from the National Institute for Health Research (NIHR), is powered to demonstrate superiority of VLA2001 in terms of Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies.
“As COVID-19 continues to impact people’s daily lives, we remain fully focused on developing another safe and efficacious vaccine solution. We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants,” said Thomas Lingelbach, chief executive officer of Valneva.
“The UK has been at the forefront of cutting-edge innovation throughout this pandemic, with Valneva’s vaccine set to be made in Scotland, if approved. We have an incredible infrastructure in place for trialing these extraordinary medical advances, and I am delighted the UK will be home to another promising vaccine trial,” added Nadhim Zahawi, UK Minister for COVID-19 Vaccine Deployment.
In February, the UK secured an additional 40 million doses of VLA2001, taking its total order to 100 million doses.
At the time, the UK government confirmed that Valneva had already started manufacturing doses of its vaccine for commercial use at its Livingstone, Scotland site.
The UK government has invested a ‘multi-million sum’ in the Livingstone plant to support the manufacturing of doses of VLA2001, with over 100 new highly skilled, local jobs already being supported by this site.
Initial results from a phase 1/2 trial of VLA2001 demonstrated that the vaccine was generally well tolerated across all dose groups tested, and was highly immunogenic with over 90% of study participants developing ‘significant’ levels of antibodies to the SARS-CoV-2 virus spoke protein.
The vaccine candidate is made of inactivated whole virus particles of SARS-CoV-2 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.