Inactivated COVID-19 vaccine candidate enters comparative immunogenicity trial
The Phase III trial aims to demonstrate that Valneva’s VLA2001 is more immunogenic than AstraZeneca’s conditionally approved COVID-19 vaccine, Vaxzevria.
Valneva has initiated a Phase III trial evaluating its inactivated COVID-19 vaccine candidate, VLA2001. The Cov-Compare trial (VLA2001-301) will compare VLA2001 to AstraZeneca’s conditionally approved vaccine, Vaxzevria (formerly COVID-19 Vaccine AstraZeneca), in a comparative immunogenicity trial.
The randomised, observer-blind, controlled, comparative immunogenicity trial was initiated after the vaccine was shown to be safe and immunogenic in its Phase I/II trial. Its primary objective is for VLA2001 to demonstrate superiority over Vaxzevria administered in a two-dose immunisation schedule, four weeks apart. Superiority will be based on Geometric Mean Titer ratio of SARS-CoV-2-specific neutralising antibodies at two weeks after the second vaccination (ie, Day 43) in those aged 30 years and older. SARS-CoV-2 is the virus that causes COVID-19.
The trial 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 UK and is supported by the UK National Institute for Health Research. 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 analysed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomised treatment group and receive VLA2001 28 days apart.
Subject to successful Phase III data, Valneva intends to make a regulatory submission in the autumn of 2021 for initial approval.
VLA2001 contains inactivated whole virus particles of SARS-CoV-2 with high Spike (S) protein density, in combination with two adjuvants, alum and Dynavax’s CpG 1018. It is intended for active immunisation of at-risk populations to prevent carriage and symptomatic infection with COVID-19.