Pre-IPO Company Launches Phase 3 COVID-19 Vaccine Study
A specialty vaccine company based in France announced it had initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
Valneva SE stated on April 21, 2021, the “Cov-Compare” (VLA2001-301) trial will compare VLA2001 against AstraZeneca’s conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial with 4,000 participants at twenty-five sites in the United Kingdom (UK).
The trial is powered to demonstrate the superiority of VLA2001 in terms of the Geometric Mean Titer (GMT) ratio (VLA2001/Vaxzevria).
The primary endpoint of Cov-Compare will be to determine the GMT of SARS-CoV-2-specific neutralizing antibodies two weeks after completion of a two-dose immunization schedule administered in a four-week interval.
Adam Finn, Chief investigator for the VLA 2001-301 program, Professor of Paediatrics at the University of Bristol, and Consultant at the Bristol Royal Hospital for Children in the UK stated in a press release, “Following very encouraging safety and immune response results from our Phase 1/2 trial, along with my investigator colleagues, I am looking forward to starting on this important next stage of the clinical development of this important new vaccine.”
“We definitely need more vaccines to help us out of this pandemic, and this one is a very promising candidate.”
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.
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.”
Thomas Lingelbach, CEO of Valenva, commented, “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, complimentary trials.”
VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®.
VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines.
VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine.
The manufacturing process for VLA2001, which has already been upscaled to the final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
SARS-CoV-2 is a new beta coronavirus identified in 2019. It belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which cause severe human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans.
The UK’s National Institute for Health Research is supporting the phase 3 trial.
Valneva SE is based in Saint-Herblain, France, and has begun the process to become a publicly-traded company. The company published its 2020 Universal Registration Document filed with the French Financial Markets Authority on April 9, 2021, under the filing number D.21-0286.
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