Valneva Initiates Further Phase 3 Clinical Trial for its COVID-19 Vaccine Candidate

Valneva SE recently announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.

VLA2001-304, which will be conducted in New Zealand, will recruit approximately 150 participants aged 56 years and older (Cohort 1) with the aim of generating additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, said “The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population. Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial”.

In June 2021, Valneva announced that it had completed recruitment for VLA2001’s pivotal Phase 3 trial “Cov-Compare” (VLA2001-301) with over 4,000 randomized participants. Valneva plans to make regulatory submissions for initial approval in the fourth quarter of 2021, subject to successful Cov-Compare data.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It 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 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. 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. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and 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 final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

Trial VLA2001-304 will enroll two cohorts. Cohort 1 will include approximately 150 volunteers aged 56 years and older in an open-label manner in order to generate safety and immunogenicity data for this age group. Cohort 2 will include approximately 600 volunteers aged 12 years and older in order to compare immunogenicity data of Valneva’s original COVID-19 vaccine candidate, VLA2001, to an additional COVID-19 vaccine candidate, VLA2101, to be based on a variant strain to be confirmed. In both cohorts, vaccinations will be administered in a 2-dose immunization schedule 28 days apart. The trial will be conducted at approximately 10 trial sites in New Zealand.

https://www.clinicaltrials.gov/ct2/show/NCT04956224

ClinicalTrials.gov Identifier: NCT04956224

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.