Valneva Launches Phase 1 Study for Zika Vaccine Candidate

On March 26, 2024, Valneva SE, a leading vaccine developer, launched a Phase 1 clinical study to evaluate the safety and ability to provoke an immune response of their Zika virus vaccine candidate, VLA1601. The Zika virus, a mosquito-borne disease with no current vaccines or treatments, poses a significant public health risk and is recognized by the FDA's Tropical Disease Priority Review Voucher Program.

The clinical trial, designated VLA1601-102, is a randomized, placebo-controlled study that aims to include approximately 150 participants between the ages of 18 and 49 in the United States. The participants will be given varying doses of VLA1601, with the potential addition of an adjuvant from either Dynavax Technologies Corporation or the Access to Advanced Health Institute (AAHI) for the lowest dose. Preliminary results from the study are anticipated to be released in the first half of 2025.

VLA1601 is developed using the same platform as Valneva's Japanese encephalitis vaccine, IXIARO®, which was also used to create their inactivated, adjuvanted COVID-19 vaccine, VLA2001. The first-generation Zika vaccine candidate demonstrated a good safety record and strong immunogenicity in a study published in 2018.

Dr. Juan Carlos Jaramillo, Valneva's Chief Medical Officer, emphasized the company's dedication to creating vaccines to combat diseases like Zika, especially as climate change expands the habitat of disease-carrying mosquitoes. A successful Zika vaccine would add to Valneva's range of travel vaccines for mosquito-borne illnesses, including the recently approved chikungunya vaccine, IXCHIQ®, and their long-standing JE vaccine, IXIARO®.

The Zika virus, discovered in 1947, has been linked to microcephaly and Guillain-Barré syndrome by the WHO. It is currently active in several regions, including Mexico, Central and South America, and parts of the Caribbean and the United States.

Valneva's IXIARO® vaccine is approved for use in various countries to protect against Japanese encephalitis and is the sole vaccine available to the U.S. military for this disease. The company's IXCHIQ® vaccine is designed to prevent chikungunya virus infection in those at risk, with approval contingent upon further clinical benefit verification.

Valneva is a specialized vaccine company with a focus on developing and commercializing vaccines for infectious diseases with unmet medical needs. They have a history of advancing vaccines from research to approval and market three proprietary travel vaccines, along with third-party vaccines.

The company's financial revenues support the ongoing development of their vaccine pipeline, which includes a Lyme disease vaccine candidate in partnership with Pfizer and candidates for the Zika virus and other global health threats.

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