Valneva SE announced the initiation of a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). There are currently no preventive vaccines or effective treatments available against ZIKV. As such, this mosquito-borne disease remains a public health threat and is included in the Food and Drug Administration's Tropical Disease Priority Review Voucher Program.

The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Topline data from the trial are expected in the first half of 2025. VLA1601 is being developed on the original manufacturing platform of Valneva's licensed Japanese encephalitis (JE) vaccine IXIARO®?, which was further optimized to develop the Company's inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe.

Phase 1 results from Valneva's first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules2. Since 2013, 31 countries and territories have reported cases of microcephaly and other central nervous system malformations associated with ZIKV infection. VLA1601 is a highly purified inactivated vaccine candidate against the virus (ZIKV), developed on the original manufacturing platforms of Valneva's licensed Japan encephalitis vaccine IXIARO®®?, which was further optimized to develop the company's inactivated, adjuvants COVID-19 vaccine V LA2001, the first COVID - VLA1601 in 2018.

In the U.S., IXCHIQ®? is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA's accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.