Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Core Insights - Valneva SE announced positive results from its Phase 1 clinical trial for VLA1601, a second-generation vaccine candidate against the Zika virus, demonstrating improved immune response and safety [1][5][7] Group 1: Clinical Trial Details - The Phase 1 trial, VLA1601-102, involved approximately 150 participants aged 18 to 49 in the U.S., who received two doses of the vaccine at varying dosages [2] - The trial evaluated the safety and immunogenicity of VLA1601, which is an aluminum-adjuvanted inactivated vaccine, with additional adjuvants tested in the low-dose group [2][4] - Data up to Day 57 indicated that VLA1601 was generally safe and well tolerated across all treatment arms, with no safety concerns identified [3] Group 2: Immunogenicity Results - VLA1601 induced an immune response across all treatment arms, with the strongest response observed in the double-adjuvanted groups, showing significantly higher neutralizing antibody titers compared to the single-adjuvant group [4] - The second-generation vaccine candidate showed higher peak seroconversion rates (>93% vs 86%) and a greater peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold) compared to the first-generation vaccine [5] Group 3: Development Context - VLA1601 is developed using the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine IXIARO®, which has been optimized for other vaccine candidates [6][9] - The Chief Medical Officer of Valneva highlighted the growing public health challenge posed by Zika virus due to climate change, but noted that further development of VLA1601 will depend on securing significant funding opportunities [7]