Vaxcyte Corporate Presentation slide image

Vaxcyte Corporate Presentation

26 VAX-24 Phase 1/2 Clinical Proof-of-Concept Study Designed to Demonstrate Non-Inferiority to SOC on Approvable Endpoint in Adults (OPA) о Study Design: Randomized, Observer-Blind, Dose-Finding, Controlled Study to Evaluate Safety & Immunogenicity of VAX-24 in Adults Screen and Randomize Pilot Safety Healthy Adults 18 to 49 (n-64) DMC Review Safety Follow- Up(1) Screen Randomize (1:1:1:1) VAX-24 Low Dose VAX-24 Middle Dose VAX-24 Mixed Dose Clinical POC Study Healthy Adults 50 to 64 (n-800) IgG & OPA VAX-24 VS Prevnar 20 (common 20 strains) Safety Follow- Up Final Safety Assessment Dose Day 0 Day 8 Day 29 Month 6 Day 0 Key Objectives: • Evaluate safety & tolerability of single injection of VAX-24 in healthy adults 18 to 49 yrs (n~64) Comparative safety & tolerability of 3 different dose . formulations of VAX-24 in healthy adults 50 to 64 yrs versus Prevnar 20 (1) Pilot Safety Follow-up will continue thru Day 212 in parallel upon initiation of Clinical POC Study after Day 29 safety observation. Prevnar 20 Dose Key Endpoints: • Blood Sample Day 29 Immunogenicity Assessment Month 6 Immunogenicity (OPA & IgG) - VAX-24 vs Prevnar 20 common serotypes - VAX-24 incremental 4 serotypes not in Prevnar 20 GMT 4-fold rise 50 to 64 yr old cohort powered at >85% to detect OPA response of ≥50% across treatment groups & dose cohorts on a per serotype basis
View entire presentation