Drifted Influenza A Virus as Experimental Challenge Agent SGS has developed a wild-type influenza A H3N2 strain for use as a challenge agent in healthy volunteer studies. A/Belgium/4217/2015 [H3N2] has been manufactured to (c)GMP and is approved for use as a challenge agent in CHIM studies with proven ability to demonstrate early efficacy for novel influenza drugs and vaccines.
A/ Pe rth/16/200 9
A/ Fu jian/411/2002
A/ Te xas/50/2012
Phylogenetic Lineage (NJ analysis) • Phylogenetic analysis of the SGS A/Belgium/ 4217/2015/ [H3N2] challenge virus has shown it to have retained 100% homology to the original wildtype isolate • A/Belgium/4217/2015/(H3N2) = Clade 3C.3b – with no adaptive changes evidenced, following a single production round in embryonated eggs, relative to original virus HA sequences
Challenge agent manufacture was undertaken by SGS in conjunction with an international CMO and a world leading academic institute to ensure compliance with regulatory guidelines, including: • GMP / GLP • ICH-GCP • US IND (FDA) and EU IMP (EMA))
A/Sw it zerland/9715293/2013
3C.3a
64
A/Samara/73/2013
87
100
SGS-421-7 seed
Original virus
59
A/Belgium/4217/2015 (H3N2)
Human challenge virus
100
A/Na va rra/745/2015
3C.3b
92
A/Hongkong/4801/2014
3C.2
A/Antal ya /1183/2014
100
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