Valneva SE (VALN)

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VLA1553: Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate


February 14, 2023

Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. First results of the trial are expected mid-2023.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the VLA1553-321 adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S).

Valneva completed rolling submission of the Biologics License Application (BLA) to the U.S. FDA for approval of VLA1553 in persons aged 18 years and above in December 2022[1]. If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S. Valneva reported final pivotal Phase 3 data for VLA1553 in March 2022[2] and final lot-to-lot consistency results in May 2022[3]. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination[4].

The VLA1553-321 adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.

Conducted in collaboration between Instituto Butantan and Valneva, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial. 754 adolescents aged 12 to 17 years were vaccinated following randomization at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity 28 days following a single vaccination with VLA1553. Participants will be evaluated for the primary endpoint and followed up to twelve months. The study will also provide the first systematic safety and immunogenicity data in participants previously exposed to chikungunya.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Recruitment completion in this study is an important milestone for the overall program. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are now looking forward to obtaining results in adolescents later this year. Chikungunya virus is a major, growing public health threat which has already impacted over 100 countries and affected millions worldwide, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.”

Dr. Esper Georges Kallas, President of Instituto Butantan, which will develop, manufacture and market VLA1553 in Low- and Middle-Income Countries, commented, “the achievement of this goal is a major milestone to expand the vaccine indication in adolescents. Based on a single-dose schedule, the VLA1553 chikungunya vaccine could become a key tool to prevent the chikungunya disease in endemics areas and fight the disease-induced public health burden.”

Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this study, added, “Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur. The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licenced for human use. Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.”

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[5]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[6], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary (SVS). At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period in the previous year. The three states that most registered cases of the disease were Pernambuco (29,700 cases), São Paulo (18,100 cases) and Paraíba (9,000 cases), respectively. In 2021, São Paulo which is the most populous state in the country, went from 468 cases to 18,156 cases compared to 20207.

https://valneva.com/press-release/valneva-completes-enrollment-for-adolescent-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/?lang=en