Valneva Reports Excellent Final Phase 1 Results for its Chikungunya Vaccine Candidate, Confirms Plans

Valneva Reports Excellent Final Phase 1 Results for its Chikungunya Vaccine Candidate, Confirms Plans Final Phase 1 results up to Month 13 confirm the excellent immunogenicity and safety profile for VLA1553, its single-shot vaccine candidate.

Company plans to accelerate program to pivotal Phase 3 trial in 2020 (subject to FDA agreement)Supportive studies on track to support End of Phase 2

Excellent and sustained immunogenicity profile in all dose groups100% seroconversionachieved at Day 14 after a single vaccinationSustained at 100 % after 12 months with no decline in neutralizing antibody titers in the groups after a single vaccination

Generally safe in all dose groupsWell-tolerated with superior safety profile in low and medium dose groups compared to high dose group with excellent local tolerability

Saint Herblain (France), November 18, 2019 a?? Valneva SE (a??Valnevaa?? or a??the Companya??), a biotech company developing and commercializing vaccines for infectious diseases with major unmet medical needs, today announced excellent final Phase 1 results for its single-shot chikungunya vaccine candidate, VLA1553.The objectives of the Phase 1 study (VLA1553-101) were to assess the safety and immunogenicity profile of VLA1553 after a single vaccination across three dose levels. TodayA?s final analysis of the study includes the safety and immunogenicity results up to Month 13 and full results from the a??intrinsic human viral challenge.a??The safety profile observed in the prior analysis, announced in May 20191, was confirmed. VLA1553 was generally safe in all dose groups. The low and medium dose groups were well tolerated and showed a superior safety profile, including viremia, compared to the high dose group. No adverse events of special interest (e.g. chikungunya infection related) and no vaccine related Serious Adverse Events (SAEs) were reported up to Month 13. The product candidateA?s local tolerability profile was excellent.
See also:
Leave a comment
  • Latest
  • Read
  • Commented
Calendar Content
«    Август 2020    »