The study was carried out at the human challenge unit within SGS's clinical pharmacology unit in Antwerp, Belgium.
The trial was designed to assess the protective efficacy of FluGen's novel M2SR vaccine against infection and illness with the SGS H3N2 challenge agent, A/Belgium/4217/2015. M2SR is a live, M2-deleted H3N2 virus from 2007, capable of only a single round of replication after intranasal administration. The study aimed to assess whether the vaccine could induce broadly protective immune responses and protect against the substantially mismatched SGS challenge strain. SGS announced the availability of its H3N2 virus in 2017 following a full GMP-compliant manufacturing process. A/Belgium is a strain related to the seasonally epidemic, non-hemagglutinating H3N2 viruses that arose during the 2010-2011 influenza season. Such antigenically drifted strains have come to predominate since 2014-2015. A/Belgium shows antigenic relevance to such strains and also to current seasonal vaccines.
In the recent clinical trial, healthy adults were randomized to receive either placebo or a single intranasal dose of M2SR vaccine. After completing the vaccination stage of the study, 99 subjects were challenged with A/Belgium. Following influenza challenge, subjects were assessed for markers regarding safety, viral shedding (vAUC) and relevant clinical signs and symptoms. Subjects are being followed for four months after the challenge to ensure a full and uneventful recovery. Currently all subjects have competed the isolation element, with study completion scheduled for Q2, 2019.
Topline results showed vaccine efficacy against the substantially drifted challenge virus, despite a mismatch greater than that seen between the marketed, injectable seasonal vaccine and the predominant influenza A virus strains in 2014-15.
"Our goal in manufacturing a novel, non-hemagglutinating, influenza A (H3N2) strain to use as a challenge agent was to improve current disease modeling and help research efforts to combat the very real threat that is posed by the influenza virus to global populations," commented Adrian Wildfire, Scientific Director at SGS. "It is heartening to see that, following a record year for hospitalizations and infant deaths from H3N2 in 2017-2018, findings are very positive for FluGen's M2SR and they confirm the strong results seen in previous phase 1 immunogenicity and preclinical challenge studies. Also, this study serves to reaffirm the antigenic relevance of the A/Belgium challenge agent and validates our controlled human infection model in assisting in the selection and development of next-generation vaccines."
SGS Life Sciences provides clinical research, bioanalytical, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and the US, SGS offers clinical trial (phase I to IV) services encompassing clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs consultancy. SGS has its own clinical unit in Belgium and two phase I patient units based in Belgium and Hungary. SGS has a wealth of expertise in first in human (FIH) studies, human challenge testing, manufacturing challenge agents, biosimilars and complex PK/PD studies with a focus on infectious diseases, vaccines and respiratory therapeutics.
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