Valneva’s inactivated COVID-19 vaccine candidate advances to Phase III trial
pharmafile | April 6, 2021 | News story | Manufacturing and Production | COVID-19, COVID-19 vaccine, Valneva, Valneva vaccine, inactivated vaccine
Specialty vaccine company Valneva’s inactivated COVID-19 jab has shown positive results in a Phase I/II trial, with a seroconversion rate of 100% in participants that received a high dose.
Seroconversion occurs when an antibody can be detected in the blood; it is an especially important measure in inactivated vaccines, as these use a killed version of the virus to offer immunity, which can often be less effective at producing antibodies.
Following the successful results, Valneva now plans to commence a Phase III clinical trial by the end of this month, subject to regulatory approval.
The study was conducted in 153 participants, aged between 18 and 55 years old. Participants were administered with a low, medium or high dosage of the vaccine candidate (VLA2001) three weeks apart.
VLA2001 was found to be highly immunogenic, with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all three groups.
Seroconversion rates for S-protein binding IgG antibodies were 89.8% in the medium dose, and 100% in the high dose group.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. This may make it well-suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines.
Thomas Lingelbach, CEO of Valneva, said: “We are extremely pleased with these results which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19. The world needs multiple vaccines as well as booster options.
“Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process. I want to thank everyone involved in the ongoing work. We could not have achieved this milestone without them.”
Matt Hancock, UK Health Secretary, added: “The UK government has funded these clinical trials and it is fantastic to see Valneva’s vaccine produces a strong immune response.
“This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved will play an important role in protecting our communities. I look forward to seeing the results of the upcoming Phase III trial.”
Jack Goddard
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