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CompletedNCT05155319EBS-UFV-001Updated Jan 20, 2025

Universal Influenza A Vaccine in Healthy Adults

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

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Human Influenza

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Keywords

  • universal
  • universal influenza vaccine
  • phase 1
  • randomized
  • double-blind
  • placebo
03

In context

Influenza, Human

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female adults (18-45 years of age, inclusive) at the Screening visit.
  • Body mass index of 18.5-32.0 kg/m\^2 (inclusive) at the Screening visit.
  • Healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing as per PI [or designee] discretion), normal PE (no clinically significant findings in the opinion of the PI [or designee]), no clinically significant findings on screening electrocardiogram (ECG) and laboratory assessments in the opinion of the PI [or designee].
  • Females must not be pregnant or trying to become pregnant.
  • Both male and female subjects agree to acceptable forms of birth control. Male subjects must not donate sperm for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Enrollment in an interventional study and/or receipt of any investigational product within 30 days prior to screening visit or during the study.
  • Currently breastfeeding or planning to be breastfeeding during the study.
  • History of severe allergic reaction(s) or anaphylaxis.
  • Known allergy to any component of the vaccine.
  • History of any known immunodeficiency or immunocompromising condition that could impact response to administration of the investigational product (e.g., leukemia, lymphoma, malignancy, renal failure, asplenia, diabetes mellitus, alcoholic cirrhosis).
  • Receipt or anticipated receipt of blood products from 180 days prior to the Screening visit through 90 days following administration of IP.
  • Positive laboratory evidence of current infection at the Screening visit with HIV 1 and 2 (as determined by HIV 1/2 antibody test), HCV (as determined by HCV antibody test), or HBV [as determined by HBV surface antigen (HBsAg) test]. Note: positive anti-HCV antibody result along with a negative HCV PCR result would not be exclusionary.
  • Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) based on the PI's (or designee's) review of tracing results at the Screening visit. [Non-pathologic sinus bradycardia (heart rate must be >40 beats per minute) is allowed].
  • Receipt or anticipated receipt of the seasonal influenza vaccination from up to 90 days prior to dosing and through up to 30 days following the last dose administration.
  • Receipt or anticipated receipt of any COVID-19 vaccine from up to 14 days prior to dosing and through up to 30 days following the last dose administration.
  • Receipt or anticipated receipt of any other vaccines from up to 90 days prior to dosing and through up to 30 days following last dose administration of investigational product.
  • Receipt or anticipated receipt of systemic immunomodulatory agents or other immune modifying drugs (including systemic corticosteroids exceeding 20 mg/day for ≥14 days) and antineoplastic agents from up to six months prior to dosing and through the entire duration of the study.
  • Planned medical procedure(s) that will impact study compliance during the follow-up period.
  • Positive urine drug screen test or any evidence of ongoing drug abuse or dependence (including alcohol), or recent history over the past five years of treatment for alcohol or drug abuse.
  • Planning to donate bone marrow, blood, and blood products from the time of screening until 3 months after receiving the last dose.
  • Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments.
  • History of H. pylori infection or documented iron deficiency within the past five years.
  • An opinion of the PI (or designee) that it would not be in the best interest of the subject to allow participation in the study.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Cohort 1, 1A

    Low dose (Day 1) plus placebo (Day 22)

    Biological: UFluA 20 µg each antigen/dose · Biological: Placebo

  • Active comparator
    Cohort 1, 1B

    Low dose (Day 1) plus low dose (Day 22)

    Biological: UFluA 20 µg each antigen/dose

  • Placebo comparator
    Cohort 1, 1C

    Placebo (Day 1) plus Placebo (Day 22)

    Biological: Placebo

  • Active comparator
    Cohort 2, 2A

    High dose (Day 1) plus placebo (Day 22)

    Biological: UFluA 60 µg each antigen/dose · Biological: Placebo

  • Active comparator
    Cohort 2, 2B

    High dose (Day 1) plus high dose (Day 22)

    Biological: UFluA 60 µg each antigen/dose

  • Placebo comparator
    Cohort 2, 2C

    Placebo (Day 1) plus Placebo (Day 22)

    Biological: Placebo

Interventions

  • BiologicalUFluA 20 µg each antigen/dose

    Low dose

  • BiologicalUFluA 60 µg each antigen/dose

    High Dose

  • BiologicalPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

07

Study locations

2 sites
  • Northern Beaches Clinical Research
    Brookvale, New South Wales 2100, Australia
  • Linear Clinical Research
    Nedlands, Western Australia 6009, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05155319
Lead sponsor
Emergent BioSolutions
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
Dec 1, 2021
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023
Last update
Jan 20, 2025

Study contacts

James McCarthy, MD
study director · Emergent BioSolutions

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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