A Phase 1 interventional study of UFluA 20 µg each antigen/dose and UFluA 60 µg each antigen/dose in Human Influenza, sponsored by Emergent BioSolutions. Completed at 2 sites in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Emergent BioSolutions · Phase 1, Interventional, and Prevention
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 27 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Emergent BioSolutions is the lead sponsor of 46 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low dose (Day 1) plus placebo (Day 22)
Biological: UFluA 20 µg each antigen/dose · Biological: Placebo
Low dose (Day 1) plus low dose (Day 22)
Biological: UFluA 20 µg each antigen/dose
Placebo (Day 1) plus Placebo (Day 22)
Biological: Placebo
High dose (Day 1) plus placebo (Day 22)
Biological: UFluA 60 µg each antigen/dose · Biological: Placebo
High dose (Day 1) plus high dose (Day 22)
Biological: UFluA 60 µg each antigen/dose
Placebo (Day 1) plus Placebo (Day 22)
Biological: Placebo
Low dose
High Dose
Placebo
Safety of the UFluA vaccine following one of four dose schedules as evaluated through adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs).
Incidence of AEs up to 4 weeks after last dose. Incidence of SAEs up to 48 weeks of study follow-up. Incidence of AESIs up to 48 weeks of study follow-up. Incidence of MAAEs up to 48 weeks of study follow-up.
Time frame: 48 weeks
Local and systemic reactogenicity of UFluA vaccination following one of four dose schedules.
Incidences of local reactogenicity events up to 7 days after each vaccination. Incidences of systemic reactogenicity events up to 7 days after each vaccination.
Time frame: seven days after each vaccination
Anti-H. pylori ferritin immune response to UFluA vaccination.
Anti-H-pylori ferritin antibody titers at multiple timepoints up to 4 weeks after the last vaccination.
Time frame: up to 4 weeks after the last vaccination.
Anti-human ferritin immune response to UFluA vaccination.
Anti-human ferritin antibody levels at multiple timepoints up to 4 weeks after the last vaccination.
Time frame: up to 4 weeks after the last vaccination.
Humoral immune response to A1 influenza antigen following UFluA vaccination.
Peak anti-A1 stem binding antibody titers (as measured by an immunoassay) at multiple timepoints up to 4 weeks after the last vaccination.
Time frame: up to 4 weeks after the last vaccination.
Humoral immune response to A2 influenza antigen following UFluA vaccination.
Peak anti-A2 stem binding antibody titers (as measured by an immunoassay) at multiple timepoints up to 4 weeks after the last vaccination.
Time frame: up to 4 weeks after the last vaccination.
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Emergent BioSolutions