NCT05155319

Universal Influenza A Vaccine in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study Evaluating Safety and Immunogenicity of Influenza A Hemagglutinin Stabilized Stem Nanoparticle Vaccine Candidate in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	UFluA 20 µg each antigen/dose	Low dose
BIOLOGICAL	UFluA 60 µg each antigen/dose	High Dose
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2021-12-13
• Last updated: 2025-01-20

Locations

2 sites across 1 country: Australia