RE: Channel 4 - Search for a vaccine reminder4 Aug 2020 11:25
Phase 2 Clinical Results for Vaccitech’s Universal Influenza A Vaccine
Jan 31, 2020
Oxford, UK – Vaccitech Ltd, a clinical-stage T cell immunotherapy company developing products to treat cancer and chronic infectious diseases, announces top line Phase 2 data and plans for its recombinant Modified Vaccinia Ankara (MVA) Universal Influenza A prophylactic vaccine, VTP-100, clinically developed to address both pandemic and seasonal influenza.
A Data Monitoring Committee (DMC) performed an unblinded analysis of interim results from FLU009, a single-blind, randomised, placebo-controlled field Phase 2b trial for seasonal influenza with 2,149 participants, sponsored in Australia by Vaccitech’s wholly-owned subsidiary, Vaccitech Australia Pty Limited. The DMC recommendation is that the trial should not be continued for a second season. The committee’s analysis indicates that while the vaccine was safe and well tolerated, the trial is unlikely to meet the primary endpoint and achieve the required level of reduction in the incidence of laboratory-confirmed influenza in participants receiving VTP-100 as an add-on to a licenced seasonal Quadrivalent Influenza Vaccine (QIV), relative to participants receiving QIV alone.
In addition, data from FLU010, a randomised, double-blind, placebo-controlled, influenza challenge Phase 2 trial for pandemic influenza in 118 healthy adults did not reach its primary endpoint of a thirty percent reduction in overall viral shedding. Vaccitech will continue its obligations under the contract with BARDA to analyse potential immunological correlates associated with protection or risk from disease. The trial was conducted under review by both the FDA and the Belgian Regulatory Authority, FAMHP.
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