The France-based biotech company Valneva has launched the phase I/II VLA2001-201 clinical study of its COVID-19 vaccine candidate, VLA2001.VLA2001 is constituted by inactivated whole virus particles of SARS-CoV-2 with high S-protein density and two adjuvants, alum and CpG 1018. VLA2001 is the first inactivated vaccine for COVID-19 to initiate clinical development in Europe, said Valneva. The vaccine leverages the manufacturing platform of the firm’s licensed Japanese encephalitis vaccine, IXIARO.The phase I/II VLA2001-201 trial will be carried out in sites across the UK and is supported by the UK National Institute for Health Research (NIHR).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. 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 2021, 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.“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 Valneva CEO Thomas Lingelbach.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, revealed the company.