Second Generation Zika Vaccine Launches Phase 1 Study in the U.S.

Valneva SE today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).

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.

The initial Phase 1 study 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 schedules.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on March 26, 2024, “Valneva’s commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus."

There are currently no preventive vaccines or effective treatments available against ZIKV. However, there are over ten Zika vaccine candidates conducting research.

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.

As of March 2024, over 1,100 Zika cases have been confirmed in the Americas this year. Ten countries accounted for about 89% of Zika outbreaks recorded between 2014 and 2023.