Zika Vaccine VLA1601 Clinical Trials, Dosage, Indication, Side Effects
Valneva SE's VLA1601 is a second-generation purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide. VLA1601 is the most advanced Zika vaccine developed and optimized on the original manufacturing platform of Valneva's licensed Japanese Encephalitis vaccine, IXIARO®. As of October 11, 2024, 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 throughout the Region of the Americas in 2024 and is included in the FDA's Tropical Disease Priority Review Voucher Program.
Valneva reported the results of its phase 1 clinical trial (NCT03425149), showing immunogenicity and safety results in 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, with a two-dose priming: Day 1 + 29 with follow-up after 1m (Day 57), 6m, and 12m. Primary Objectives: assessment of safety and tolerability up to 7 days after each vaccination and assess immunogenicity at Day 57 (1m after completion of priming). Topline data from this phase 1 clinical trial are expected in 2025. The Company has plans for accelerated approval with government agencies.
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 by French Decree No. 2017-1265 of August 9, 2017.
Zika Vaccine VLA1601 Indication
VLA1601 is a vaccine candidate that is indicated to prevent Zika infection. Vaccination should prevent Zika infection and protect against severe complications.
Zika Vaccine Dosage - VLA1601
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.
Zika Virus Impact
First identified in Uganda in 1947 in monkeys, Zika was later identified in humans in 1952. According to the World Health Organization, there is scientific consensus that ZIKV causes cases of microcephaly and Guillain-Barré syndrome. As of October 2024, 89 countries and territories have reported evidence of mosquito-transmitted Zika virus infection; however, surveillance remains limited globally.
Zika Vaccine VLA1601 News
October 10, 2024 - Valneva SE presented its product update.
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 that a vaccine against the Zika virus would 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.