Valneva Initiates Pivotal Phase 3 Clinical Trial for its Inactivated, COVID-19 Vaccine Candidate using Dynavax's CpG 1018™ Adjuvant
The initiation of the Cov-Compare trial follows positive initial results from Valneva's Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development.
Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 adults. Its primary objective is 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. and is supported by the
Subject to successful Phase 3 data, Valneva intends to make a regulatory submission in the autumn of 2021 for initial approval.
VLA2001 is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. The process includes inactivation with BPL to preserve the native structure of the S-protein. Valneva expects VLA2001 to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
About CpG 1018 Adjuvant
CpG 1018 adjuvant is used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the
Dynavax Forward Looking Statements
This press release contains "forward-looking statements", including statements regarding the potential development (including but not limited to the timing and potential outcome) of the Phase 3 clinical trial of VLA-2001, regulatory submission and importance of a COVID-19 vaccine containing CpG 1018 adjuvant, the potential of the platform to address variants, and the evaluation of the other trials. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, dose selection, the results of clinical trials, whether and when the vaccine containing CpG 1018 adjuvant will be approved for use, whether and when purchases of CpG 1018 adjuvant will occur, and the ability to manufacture sufficient supply to meet the purchase needs, as well as other risks detailed in the "Risks Factors" section of our Annual Report on Form 10-K for the fiscal year ended
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