A total of 60 healthy adult subjects will be enrolled in the study and followed through Day 337 (i.e., up to 48 weeks after first dose). Subjects will be enrolled into two study cohorts to receive either a low dose (Cohort 1; n=30 receives) or high dose (Cohort 2; n=30) of adjuvanted UFluA or placebo (saline), administered intramuscularly (IM) as single dose or as two doses (administered 21 days apart).~UFluA is comprised of DP-UFluA (1:1 A1-ssnp and A2-ssnp antigens) and contains aluminum hydroxide and CpG adjuvants.~Primary Objective:~To evaluate safety and tolerability of UFluA IM administration in healthy adults.~Secondary Objectives:~To assess anti-hemagglutinin humoral immune responses in healthy adults who receive UFluA. To assess ferritin (Helicobacter pylori and human) immune response in healthy adults who receive UFluA.
The goal of this Phase 1, single- center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability and immunogenicity of UFluA vaccine candidate at two dose levels and two schedules in healthy adult (18-45-year-old, inclusive) male and non-pregnant female subjects.