December 16, 2020 -- Valneva has begun a phase I/II clinical trial to study its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
The randomized, double-blind, placebo-controlled trial will evaluate the safety and immunogenicity of VLA2001 for three dose levels in approximately 150 healthy adults. The study will be conducted in sites across the U.S. and is supported by the National Institute for Health Research. The primary end point is the prevention of COVID-19 two weeks after completion of the two-dose immunization.
The company expects data from the study, including dose selection, to be available in the second quarter of 2021. Larger planned studies will include up to 4,000 participants with the goal of receiving regulatory approval as soon as the fourth quarter of 2021.
The vaccine candidate contains inactivated whole virus particles of SARS-CoV-2 with high spike protein density, in combination with two adjuvants, alum and CpG 1018. It is produced on Valneva's established Vero cell platform that is also used to manufacture its licensed Japanese encephalitis vaccine (Ixiaro). Large-scale process development for the candidate has already been achieved. The vaccine is expected to conform with standard cold chain requirements (2-8° C).
In September, Valneva announced a major COVID-19 vaccine partnership with the U.K. government. Under the agreement, if vaccine development is successful, Valneva will provide the U.K. government with 60 million doses in the second half of 2021. The government has options to acquire a further 130 million doses from 2022-2025. The U.K. government has also invested in the up-front scale-up and development of the vaccine, with the investment being recouped against the vaccine supply.