Valneva SE, has initiated a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. The study will be conducted in study sites across the United Kingdom and is supported by the National Institute for Health Research (NIHR).
VLA2001 is Valneva’s vaccine candidate against the SARS-CoV-2 virus. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the cellular immune response towards Th1. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese Encephalitis Vaccine, IXIARO. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B vaccine.
VLA2001-201 is the first-in-human Phase 1/2 study that will evaluate three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited. The study will start with an open-label dose-escalation phase. Following review of safety data by an independent Data Safety Monitoring Board (DSMB), the study will be conducted as a randomized, double-blind, multicenter study. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated.
The primary endpoint read-out will be two weeks after completion of the two-dose primary immunization (day 0, 21). Subject to analysis of this data, including the selection of the optimal dose currently expected in the early second quarter of 2021, additional trials are expected to commence immediately thereafter.
The Company currently plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval as soon as the fourth quarter of 2021.
“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 Alok Sharma, UK Secretary of State for Business, Energy and Industrial Strategy. “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. Having visited Valneva’s state-of-the art facility in the summer, I have seen first-hand the incredible work our scientists and researchers are doing to develop this vaccine. Thanks to significant investment from the UK government, we are doing all we can to ensure our country has the capabilities in place to produce hundreds of millions of doses of this vaccine for the UK, and for those around the world.”
In September 2020, 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 UK government with 60 million doses in the second half of 2021 and UK government has options over provision of a further 130 million doses from 2022-2025. UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply.