VLA1601 Zika Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

Valneva SE's VLA1601 is a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide. VLA1601 was developed on the original manufacturing platform of Valneva's licensed Japanese Encephalitis vaccine, IXIARO®, which was further optimized. No preventive vaccines or effective treatments against ZIKV are approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). As such, this mosquito-borne disease remains a public health threat and is included in the FDA's Tropical Disease Priority Review Voucher Program.

Valneva reported Phase 1 clinical trial (NCT03425149) results from its first-generation Zika vaccine candidate in 2018, showing excellent immunogenicity and safety results in all tested doses and schedules. On March 26, 2024, Valneva announced the initiation of an additional Phase 1 clinical trial (VLA1601-102) to investigate the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the ZIKV.

France-based Valneva is a specialty vaccine company focused on preventing diseases with significant unmet needs. Valneva's vaccine portfolio includes two commercial vaccines for travelers. Valneva's 2023 Sustainability Report offers an in-depth account of activities and the Group's priorities in the future. The Report's format is in accordance with French Decree No. 2017-1265 of August 9, 2017.

VLA1601 Zika Vaccine Indication

VLA1601 is a vaccine candidate that is indicated to prevent Zika infection. First identified in Uganda in 1947 in monkeys, Zika was later identified in humans in 1952. Since 2015, Zika outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and the Americas. Led by Brazil, ten countries account for about 89% of Zika cases recorded between 2014 and 2023. As of early 2024, Zika outbreaks have been reported by the Pan American Health Organization (PAHO) throughout South and Central America. To date, 89 countries and territories have reported evidence of mosquito-transmitted Zika virus infection; however, surveillance remains limited globally.

According to the World Health Organization, there is scientific consensus that ZIKV causes cases of microcephaly and Guillain-Barré syndrome.

VLA1601 Zika Vaccine Dosage

In a phase 1 clinical trial, VLA1601 was administered intramuscularly in the deltoid muscle. Each dose is administered intramuscularly in the deltoid muscle on Days 0 and 28. Also, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.

VLA1601 Zika Vaccine News

March 26, 2024 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "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. As global temperatures rise and rainfall increases, the habitat for disease-carrying mosquitoes expands, presenting an ongoing public health challenge."

March 20, 2024 - Valneva SE stated a vaccine against the Zika virus would nicely complement the Company's portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®.

November 9, 2023 - The Company announced the re-initiation of clinical development for ZIKA VACCINE CANDIDATE—VLA1601, with further program evaluation planned.

March 30, 2023 - Valneva'seva's Chief Medical Officer, Juan Carlos Jaramillo, MD, will host a discussion on the opportunities and challenges of developing Zika vaccines on April 4, 2023.

VLA1601 Clinical Trial

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. Participants will receive a low, medium, or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant, either the CpG 1018® adjuvant from Dynavax Technologies Corporation or the 3M-052-AF adjuvant from the Access to Advanced Health Institute. Topline data from the trial are expected in the first half of 2025.

Valneva concluded the Phase 1 trial NCT03425149. It was first posted on February 7, 2018, and Last Updated on July 5, 2019.