Slide 1: Safety and Immunogenicity of the Seasonal Influenza VLP (Trivalent) Vaccine: Phase IIa Results
Safety and Immunogenicity of the Seasonal Influenza Virus-Like Particle (Trivalent) Vaccine in Healthy Adults: Results of a Phase IIa Study
Slide 2: Agenda
Agenda Design of Phase IIa Clinical Trial Safety Results Immunogenicity Results Conclusions and Implications
Slide 3: Clinical Goals of the Seasonal Influenza VLP (Trivalent) Vaccine Program
Clinical Goals of the Seasonal Influenza VLP (Trivalent) Vaccine Program Develop a safe and effective vaccine against the influenza sub-types responsible for yearly epidemics (H3N2, H1N1, B) Develop a vaccine that induces a broad immune response Improved efficacy in older adults >65 years over exist
Slide 4: Objectives and Overview of a Phase IIa Clinical Trial of VLP Vaccine
Objectives Overview of a Phase IIa Clinical Trial of the Seasonal Influenza VLP Vaccine To evaluate the safety and immunogenicity of the seasonal influenza VLP vaccine Sample: 300 healthy adult subjects, 18 to 49 years of age Safety evaluation following vaccination: All adverse events (AEs) through
Slide 5: Safety of the Influenza VLP Vaccine
Safety of the Influenza VLP Vaccine The types of non-serious adverse events reported are similar to what has been observed with other influenza vaccines No serious adverse events (AEs) have been reported to date Fever Myalgia Arthralgia Headache Fatigue Placebo 1.9 5.7 0 11.3 9.4 5 mcg 5.7 24.5 5.7
Slide 6: HAI Responses Against Vaccine Strains
HAI Responses Against Vaccine Strains H3N2 (A/New York) - % Seroprotection* - % Seroconversion** - GMT* H1N1 (A/New Cal.) - % Seroprotection* - % Seroconversion** - GMT* B Jiangsu - % Seroprotection* - % Seroconversion** - GMT* 15 mcg 30 mcg Vaccination Group 95 100 210 83 69 132 73 42 58 97 90 324
Slide 7: HAI Responses Against Drifted Strains
HAI Responses Against Drifted Strains H3N2 (A/Wisconsin) - % Seroprotection* - % Seroconversion** - GMT* H1N1 (A/Solomon Is.) - % Seroprotection* - % Seroconversion** - GMT* B Malaysia - % Seroprotection* - % Seroconversion** - GMT 15 mcg 30 mcg Vaccination Group 96 100 279 78 36 126 38 7 23 97 92 4
Slide 8: Progress on the Goals for VLP (Trivalent) Vaccine Program
Improved Efficacy Early Season Delivery Cross-reactivity Strain-matched Clinical data from seasonal study suggest higher doses lead to higher HAI titers Clinical data from the pandemic study suggest that VLPs activate CD8+/CTLs Preclinical seasonal studies show VLPs induce anti-NA and NAI activity C
Slide 9: Development Plans for 2009
Development Plans for 2009 Conduct studies in healthy adults to finalize dose and continue evaluating safety and immunogenicity in this population Conduct dose ranging studies in elderly adults (>65 years old) including comparison with a currently licensed influenza vaccine Continue to optimize manu