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The company made a new strain of the influenza virus available for use as a challenge agent in clinical trials.
SGS made a new strain of the influenza virus available for use as a challenge agent in clinical trials on Jan. 10, 2017. The synthetic virus may be used to test the efficacy of both novel influenza drugs and vaccines in healthy volunteers.
The new agent is a H3N2-type virus, which represents one of the common current circulating strains of influenza of a pandemic origin. Its manufacture has been undertaken by SGS in accordance with good manufacturing practice to ensure that strict FDA and European Medicines Agency regulatory guidelines are met. The virus is currently undergoing an array of both adventitious and purity tests. It is anticipated that final safety and activity data from the first-in-human studies using the virus will be announced in a presentation at the World Vaccine Congress, to be held in Washington DC, in April 2017.
The company has a containment-Level 2, 20-bed human challenge unit providing full isolation capabilities and offering services for challenge trials performed with the new influenza agent. The unit is located in Antwerp’s Stuivenberg Hospital, Belgium.