Valneva has announced that it has initiated a pivotal Phase 3 clinical trial in the UK for its inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001.
“The Phase 3 trial ‘Cov-Compare’, (VLA2001-301), will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial,” the company said yesterday (April 21).
Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response two weeks after completion of a two-dose immunization schedule administered in a four-week interval.
The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the UK and is supported by the National Institute for Health Research (NIHR).
Thomas Lingelbach, Chief Executive Officer of Valneva, commented: “This Phase 3 initiation marks a significant milestone in the development of the only inactivated vaccine candidate against COVID-19 in clinical trials in Europe.
“As Covid-19 continues to impact people’s daily lives, we remain fully focused on developing another safe and efficacious vaccine solution. We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants. While Cov-Compare is progressing we are planning to conduct additional, complementary trials.”
The UK Minister for Covid-19 Vaccine Deployment, Nadhim Zahawi, said: “The UK has been at the forefront of cutting-edge innovation throughout this pandemic, with Valneva’s vaccine set to be made in Scotland, if approved. We have an incredible infrastructure in place for trialing these extraordinary medical advances, and I am delighted the UK will be home to another promising vaccine trial.
“I’ve taken part in a vaccine clinical trial myself and would urge all those thinking about signing up to go for it, and to play a part in helping protect your loved ones and saving lives.”
The initiation of the Cov-Compare trial follows the announcement of initial results from Valneva’s Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development. Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.