Valneva SE has initiated a Phase 3 clinical trial 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, states Valneva in a press release.
Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) 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), states Valneva. The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).
“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.”
“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,” says Thomas Lingelbach, Chief Executive Officer of Valneva.
Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.