Emergent BioSolutions and Valneva Report Positive Phase 1 Results for Their Vaccine Candidate Against the Zika Virus
The highly purified inactivated vaccine candidate, VLA1601, met the study’s primary endpoint showing a favorable safety profile in all doses and schedules tested.
VLA1601 was also immunogenic in all treatment groups and induced both dose- and schedule-dependent neutralizing antibodies against the Zika virus with the kinetics expected for an inactivated, alum-adjuvanted whole-virus vaccine. Seroconversion Rates (SCR) reached up to 85.7% on Day 35 (Interim Analysis of Data up to Day 56).
The Phase 1 study was designed to assess safety and immunogenicity. It is being co-financed by Emergent and Valneva as part of an exclusive, worldwide license agreement signed in
About the Phase 1 Clinical Study VLA1601-101
VLA1601-101 is a first-in-human, randomized, placebo-controlled and observer-blinded study. It is assessing the safety and immunogenicity of two different dose levels of the alum adjuvanted, inactivated whole virus Zika vaccine candidate VLA1601 in 67 healthy, flavivirus-naïve adults aged 18-49 years. The study is being conducted in
Participants received two vaccinations with a lower (3AU) or higher dose (6AU) – either 7 or 28 days apart.
The current analysis includes full, final data for all analyses (safety and immunogenicity) up to day 56 after the first vaccination.
The final analysis at day 208 after first vaccination, which is expected in the first quarter 2019, will include additional immunogenicity data such as Geometric Mean Titres (GMTs), rate of subjects with seroconversion and fold-increase of ZIKA virus specific neutralizing antibodies titres as compared to base-line, measured by PRNT.
Additional information, including a detailed description of the study design and eligibility criteria is available at ClinicalTrials.gov using identifier NCT03425149.
About Zika Virus
The Zika virus is a mosquito-borne flavivirus that was first discovered in 1947. The first human cases were detected in 1952. Since then, outbreaks have been reported in tropical
According to the
About VLA1601
VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus, developed using the same manufacturing platform as Valneva’s IXIARO® (JESPECT®) Japanese Encephalitis (“JE”) vaccine. In pre-clinical development, VLA1601 demonstrated excellent purity and had an overall biological, chemical and physical profile comparable to the commercially produced JE vaccine. Valneva has an established manufacturing process in its dedicated clinical JE vaccine facility.
About the exclusive worldwide license for Valneva’s Zika vaccine technology
On
About
About
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.
Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in
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