Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001 - Seite 2

UK Minister for COVID-19 Vaccine Deployment, Nadhim Zahawi, added, “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 development². Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.

About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally³. It has been declared a pandemic by the World Health Organization (WHO).

About Phase 3 Trial Cov-Compare (VLA2001-301)
Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 Adults.

Primary objectives are to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.

The trial will be conducted at approximately 25 sites in the U.K. Approximately 3,000 participants 30 years of age and older will be randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomized treatment group and receive VLA2001 28 days apart.