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     443  0 Kommentare Valneva Commences Manufacturing of its Inactivated, Adjuvanted COVID-19 Vaccine, Completes Phase 1/2 Study Recruitment - Seite 2

    About VLA2001
    VLA2001 is Valneva’s vaccine candidate against the SARS-CoV-2 virus. 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. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B vaccine and received positive CHMP on December 10, 2020. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About VLA2001-201
    VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years have been recruited. The study, which included an open-label dose-escalation phase, is now fully enrolled and is expected to report initial results in April 2021. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated.

    About Valneva SE
    Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO/JESPECT indicated for the prevention of Japanese encephalitis and DUKORAL indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees.

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    Valneva Commences Manufacturing of its Inactivated, Adjuvanted COVID-19 Vaccine, Completes Phase 1/2 Study Recruitment - Seite 2 Vaccine production initiated to optimize timeline for potential deliveries Phase 1/2 clinical study now fully enrolled; initial data read out expected in April 2021 Saint-Herblain (France), January 28, 2021 – Valneva SE, a specialty vaccine company …