Speciality vaccine company, Valneva, has announced a further phase 3 trial of its COVID-19 vaccine candidate, VLA2001.
The trial aims to generate additional safety and immunogenicity data in older people, a crucial population for any COVID-19 vaccine.
“The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population,” said Valneva chief medical officer, Juan Carlos Jaramillo. “Everyone should have access to technology best suited to protect them against this virus.”
The French biotech’s new trial (VLA2001-304) will also test VLA2001 and a second vaccine candidate, VLA2001, against a variant to be confirmed later.
“We have also been working on variants of concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants,” said Jaramillo.
In June, the company announced it had finished recruitment for its Cov-Compare trial, which will test VLA2001 against AstraZeneca’s Vaxzevria, involving 4,000 randomized participants. Valneva hopes to make regulatory submissions in the fourth quarter of 2021, subject to successful Cov-Compare data.
Although SK bioscience has announced it will start trials for its “promising” vaccine candidate, GBP510 soon, at present VLA2001 is the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
Valneva’s primary goal for its vaccine is to immunise at-risk populations to prevent SARS-Cov2 infection, although it could later be used for “routine vaccination including addressing new variants” as well as for use as a booster.
VLA2001 is produced using Valneva’s Vero-cell platform, developed for the company’s Japanese encephalitis vaccine, Ixiaro.
The VLA2001-304 trial involves two cohorts. The first, involving 150 volunteers aged 56+, will generate safety and immunogenicity data for this older age group, while the second, involving 600 volunteers over the age of 12, will compare VLA2001 with Valneva’s second COVID-19 vaccine candidate, VLA2101, using a variant strain to be confirmed later.