SGS announced the successful completion of a Phase I clinical trial of a new strain of influenza virus in healthy volunteers.
The study used a GMP-manufactured, non-hemagglutinating, wild-type strain of Influenza A H3N2 in humans at single, ascending titers to determine attack rate (AR), viral area under curve (vAUC) and symptoms following nasal inoculation. The First-in-Human trial demonstrated that the novel challenge agent had high attack rates of up to 100%, no ‘blipping’ at the highest titer and strong symptoms consistent with a non egg-adapted, wild-type influenza virus.
The SGS challenge agent has lineage from the seasonally epidemic, non-haemagglutinating, H3N2 viruses that arose in the 2010-2011 influenza season and have come to predominate since 2014-2015. This strain represents one of the common current circulating strains of influenza of a pandemic origin. A/Belgium therefore offers the potential for testing the H3N2 portion of prospective prophylactic and therapeutic vaccines.
Project Director for Infectious Diseases at World Vaccine Congress in Washington DC, Mr. Adrian Wildfire said that the outcome of this trial and validation of the virus strain for human challenge trials means future research will not be reliant upon seasonal incidence of influenza, and efficacy of developmental vaccines can be determined directly by measuring multiple clinical endpoints. This approach is safer for study participants, and informed go/no go decisions can be made sooner to avoid potentially costly late phase failures.
Challenge agent manufacture has been undertaken by SGS in strict accordance with Good Manufacturing Practice to ensure that regulatory guidelines in both the US and EU (FDA and EMA) are met.