U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

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U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

Advax enhances response to pandemic avian influenza vaccine

Advax H1N1/2009 vaccine approach Recombinant H1/2009 HA (Protein Sciences Corporation) combined with Advax adjuvant Vaccine produced and ready for clinical trials within 6 weeks of pandemic declaration Trials commenced in Adelaide 20 July first human H1N1/09 trial Over 3 weeks recruited ~281 adults aged including subjects with chronic disease (only excluded children and pregnant women) Commercial in Confidence

H1N1/2009 vaccine results 6 groups: 3, 11 and 45ug HA H1N1 doses +/1 Advax adjuvant PSC H1N1 antigen was extremely tolerated Excluding local tenderness in mild category, local and systemic AE rates were no different between adjuvanted and nonadjuvanted groups Baseline H1N1 seroprotection rate (~5%) – no age relationship Dose-dependent seroprotection (~40% across study) maximal at 45ug HA dose with Advax Advax significantly increased seroprotection rates (RR ~1.6) vs HA alone Response highly age dependent, with low response in subjects >50 unless received vaccine with Advax Commercial in Confidence

Summary PSC’s recombinant HA technology able to deliver new pandemic vaccine extremely fast HA antigen extremely well tolerated In situations where low immunogenicity may be encountered, the PSC antigen can be successfully complemented with Advax adjuvant technology