According to the company, the agent is approved for use as a challenge agent in studies demonstrating the early efficacy of influenza drugs and vaccines in healthy volunteers.
The challenge agent was manufactured by SGS in accordance with Good Manufacturing Practice (GMP) and the study was carried out at the company’s purpose-built human challenge unit.
Adrian Wildfire, Project Director for Infectious Diseases and the Human Challenge Unit told us the challenge trial encountered many hurdles during the preparatory period to challenging the subjects.
“Primarily the identification of a candidate virus likely to give a high attack rate and a good symptom profile with minimal side effects, manufacturing the agent to GMP whilst retaining fidelity to wild type, regulatory considerations on the period of isolation required, and also screening patients prior to admission to ensure they were not infected with another, competing virus,” he added.
However, Wildfire said he believes the virus represents the next generation of challenge agents and “moves the game forward in producing data much closer to that observed in the field.”
As for next steps, he explained more evidence for the efficacy of the challenge virus needs to be gathered through its use in clinical trials.
“Studies with combined challenge agent strains e.g. H1N1 and H3N2 also offer increased potential for proof of efficacy in multivalent or polyvalent vaccine trials,” he explained.
“The development of new and more effective challenge agents will be needed if the human challenge model is to achieve its potential. Some models are currently sub-optimal and may damage the model and some developmental pipelines.”
Expanded storage capacity
The clinical and bioanalytical solutions provider also recently announced that it has expanded storage capacity at its Mississauga, Canada-based laboratory.
According to the company, the investment increases total storage capacity at the facility by nearly 200 cubic meters to approximately 450 cubic meters.
The additional capacity is split between six new chambers covering r four standard storage conditions: 2-8 degrees Celsius, minus 20 degrees Celsius, 30 degrees Celsius / 65% relative humidity, and 40 degrees Celsius / 75% relative humidity.