Valneva Reports Positive Results for Phase 1 Trial of SecondGeneration Zika Vaccine Candidate
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive results of its Phase 1 clinical trial investigating the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).
The randomized controlled Phase 1 trial, VLA1601-102, enrolled approximately 150 participants aged 18 to 49 years in the United States. Participants received two administrations, four weeks apart, of a low, medium or high dose of the highly purified inactivated aluminum-adjuvanted vaccine candidate VLA1601. In addition, the low dose of VLA1601 was evaluated with additional adjuvants, either the CpG 1018® adjuvant from Dynavax Technologies Corporation or the 3M-052-AF adjuvant from the Access to Advanced Health Institute (AAHI).
Data up to Day 57 (four weeks after the second dose (Part A Analysis)) showed that VLA1601 was generally safe and well tolerated in all five treatment arms, and no safety concerns were identified. Additionally, an independent Data Safety Monitoring Board did not reveal any safety issues.
Two doses of VLA1601 were immunogenic across all five treatment arms investigated (i.e., alumadjuvanted Low, Medium and High antigen dose; Low with additional adjuvants). The strongest immune response was observed in the double-adjuvant treatment arms (Low+alum+3M-052-AF and Low+alum+CpG1018) with statistically significantly higher neutralizing antibody titers (Geometric Mean Titers - GMTs) at Day 43 and Day 57 than in the single-adjuvant (alum) treatment arm.
The immune response induced by the double-adjuvanted VLA1601 second generation vaccine candidate was successfully improved compared to the first-generation vaccine candidate with higher peak seroconversion rates (>93% vs 86%) and peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold). Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018.
VLA1601 is developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased by the notable safety and immunogenicity results demonstrated for our Zika vaccine candidate and especially our double-adjuvantation results. As global temperatures rise and rainfall patterns shifts, the expanding habitat of disease-carrying mosquitoes poses a growing public health challenge for infections such as Zika.”
Despite the medical need, regulatory pathways and market opportunities for potential Zika vaccines remain uncertain. Valneva will therefore only consider further potential development steps for VLA1601 if concrete major private and public funding opportunities materialize.
Contact
Laetitia Bachelot-Fontaine VP
Global Communications and European Investor Relations
M +33 (0)6 4516 7099
communications@valneva.com
Joshua Drumm, Ph.D. VP
Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com