Life sciences pharmaceutical clinical and bioanalytical contract solutions provider, SGS, has announced that it will use a new strain of influenza virus as a challenge agent in clinical trials.
Flu
The use of the synthetic virus could potentially be used to test the efficacy of both new influenza drugs and vaccines in healthy volunteers.
The new agent is one of the common current circulating strains of influenza of pandemic origin. It is a H3N2 type virus and will be manufactured by SGS in accordance with Good Manufacturing Practice. This is to ensure that strict regulatory guidelines in both the US and EU are met.
The final safety and activity data from the first in-human studies using the virus are expected to be announced at the World Vaccine Congress in Washington later this year.
Adrian Wildfire, SGS project director infectious diseases and viral challenge unit said: “This announcement marks a significant milestone for our work in infectious disease research, and we believe this new strain will offer unique advantages over other influenza challenge agents. The new H3N2 strain was selected from a number of differing isolates of influenza following extensive comparative testing, after showing to be associated with a moderate, uncomplicated illness, and a full recovery.”