CASE STUDY
Phase 2a Study in Influenza A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of a Vaccine Administered as a Single Intranasal Dose in Healthy Adult Volunteers Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus. Drugs • Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine • Challenge agent: Live, Antigenically Different Wild-type Influenza Type A Virus (A/ Belgium/4217/2015 H3N2) Key Challenges • Serum prescreening of 547 HVs to enroll 99 serosusceptible (≤10MNT) subjects
• Intensive NP sampling schedule and SSC assessments • 108 vaccinations and 99 subjects challenged in double-blind cohorts over 3 months Outcomes • No adverse events associated with the novel, live IN vaccine • Broad vaccine efficacy as evidenced by protection against a highly mismatched influenza challenge agent • 62 percent reduction in vAUC compared to placebo • 51 to 56 percent reduction in symptom scores • Vaccine advanced to field trials based on significant CHIM results
• >100 nasopharyngeal swab assays (matrixed PCR) to exclude subjects with concomitant infection/s prior to isolation • Intranasal inoculation of live vaccine and live challenge virus
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