Universal Influenza A Vaccine in Healthy Adults

NCT05155319 | Completed Phase 1 DMC

• 1 other identifier: EBS-UFV-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Human Influenza

Keywords

universal; universal influenza vaccine; phase 1; randomized; double-blind; placebo

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  seven days after each vaccination

Secondary Outcomes (4)

• Anti-H. pylori ferritin immune response to UFluA vaccination.

  up to 4 weeks after the last vaccination.

• Anti-human ferritin immune response to UFluA vaccination.

  up to 4 weeks after the last vaccination.

• Humoral immune response to A1 influenza antigen following UFluA vaccination.

  up to 4 weeks after the last vaccination.

• Humoral immune response to A2 influenza antigen following UFluA vaccination.

  up to 4 weeks after the last vaccination.

Study Arms (6)

Cohort 1, 1A

ACTIVE COMPARATOR

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

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

Cohort 1, 1B

ACTIVE COMPARATOR

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

Biological: UFluA 20 µg each antigen/dose

Cohort 1, 1C

PLACEBO COMPARATOR

Placebo (Day 1) plus Placebo (Day 22)

Biological: Placebo

Cohort 2, 2A

ACTIVE COMPARATOR

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

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

Cohort 2, 2B

ACTIVE COMPARATOR

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

Biological: UFluA 60 µg each antigen/dose

Cohort 2, 2C

PLACEBO COMPARATOR

Placebo (Day 1) plus Placebo (Day 22)

Biological: Placebo

Interventions

UFluA 20 µg each antigen/dose BIOLOGICAL

Low dose

Cohort 1, 1A; Cohort 1, 1B

UFluA 60 µg each antigen/dose BIOLOGICAL

High Dose

Cohort 2, 2A; Cohort 2, 2B

Placebo BIOLOGICAL

Placebo

Cohort 1, 1A; Cohort 1, 1C; Cohort 2, 2A; Cohort 2, 2C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (2)

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• James McCarthy, MD

  Emergent BioSolutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 13, 2021
• Study Start: December 1, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)