Valneva starts clinical trials in UK for COVID-19 vaccine candidate

A Phase 1/2 clinical study is getting underway in the United Kingdom for Valneva SE’s vaccine candidate against the SARS-CoV-2 virus responsible for COVID-19.

The French pharmaceutical company said on Wednesday that the VLA2001-201 study is a randomized, double-blind trial to evaluate the safety and immunogenicity for three-dose levels that will be given to roughly 150 healthy UK adults aged 18 to 55 years.

“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. 

The study will be conducted in sites across the UK and is supported by the country’s National Institute for Health Research. Valneva also plans to include more than 4,000 participants in additional trials, which the company said could support an initial regulatory approval as soon as the fourth quarter of 2021.

“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,” Lingelbach said. 

Valneva in September inked a COVID-19 vaccine partnership agreement with the UK government. If successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. 

Additionally, the UK government — which is investing up-front in the scale-up and development of the vaccine and will recoup its investment against the vaccine supply — has options over the provision of another 130 million doses from 2022 through 2025, under terms of the agreement.

“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,” said Alok Sharma, UK Secretary of State for Business, Energy and Industrial Strategy. “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.”

The vaccine candidate VLA2001 leverages the manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine, IXIARO, and is the first publicly announced inactivated vaccine against COVID-19 to begin clinical development in Europe. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density that will be combined with two adjuvants, alum and CpG 1018. This combination, Valneva says, has consistently induced higher antibody levels in preclinical experiments compared to alum-only formulations.

The VLA2001-201 study will be 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, further clinical studies may be initiated, Valneva said.

“Growing the whole virus and then inactivating it to make a vaccine is an approach first developed in the 1950s and has contributed to disease prevention over many decades,” said Adam Finn, chief investigator for the VLA 2001-201 program and professor of pediatrics at the University of Bristol in England. “We expect this inactivated vaccine containing two adjuvants could generate a broader immune response.”