France-based specialty vaccine company Valneva has commenced the Phase I/II VLA2001-201 clinical study of its Covid-19 vaccine candidate, VLA2001.
VLA2001 has inactivated whole virus particles of SARS-CoV-2 with high S-protein density and two adjuvants, alum and CpG 1018.
Valneva noted that VLA2001 is the first inactivated vaccine for Covid-19 to initiate clinical development in Europe, and leverages the manufacturing platform of the firm’s licensed Japanese encephalitis vaccine, IXIARO.
Supported by the UK National Institute for Health Research (NIHR), the trial will be carried out in sites across the country.
The randomised, double-blind and placebo-controlled trial will analyse the safety and immunogenicity of the vaccine at three dose levels three weeks apart in around 150 healthy adults.
Initially, the study will begin with an open-label dose-escalation phase and the participants will receive intramuscular doses of the vaccine.
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The primary endpoint read-out will be two weeks following the conclusion of the two-dose primary immunisation given on days 0 and 21.
Following the analysis of this data, including the optimal dose selection, which will be done in the second quarter of next year, additional trials are expected to begin.
Valneva intends to include over 4,000 subjects in the additional trials, which could aid in initial regulatory approval by the fourth quarter of next year.
Valneva CEO Thomas Lingelbach said: “Our teams have been working extremely hard to develop our differentiated vaccine candidate and I would like to thank them, as well as the UK Government, for their dedication and support.
“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.”
UK Business, Energy and Industrial Strategy State Secretary Alok Sharma said: “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.
In September, Valneva entered a Covid-19 vaccine partnership with the UK Government to supply 60 million doses of the vaccine in the second half of next year if proven successful.
The UK Government also has the option to procure 130 million doses from 2022 to 2025.