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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05155319




Registration number
NCT05155319
Ethics application status
Date submitted
25/11/2021
Date registered
13/12/2021

Titles & IDs
Public title
Universal Influenza A Vaccine in Healthy Adults
Scientific title
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
Secondary ID [1] 0 0
EBS-UFV-001
Universal Trial Number (UTN)
Trial acronym
EBS-UFV-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - UFluA 20 µg each antigen/dose
Treatment: Other - UFluA 60 µg each antigen/dose
Treatment: Other - Placebo

Active comparator: Cohort 1, 1A - Low dose (Day 1) plus placebo (Day 22)

Active comparator: Cohort 1, 1B - Low dose (Day 1) plus low dose (Day 22)

Placebo comparator: Cohort 1, 1C - Placebo (Day 1) plus Placebo (Day 22)

Active comparator: Cohort 2, 2A - High dose (Day 1) plus placebo (Day 22)

Active comparator: Cohort 2, 2B - High dose (Day 1) plus high dose (Day 22)

Placebo comparator: Cohort 2, 2C - Placebo (Day 1) plus Placebo (Day 22)


Treatment: Other: UFluA 20 µg each antigen/dose
Low dose

Treatment: Other: UFluA 60 µg each antigen/dose
High Dose

Treatment: Other: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
48 weeks
Primary outcome [2] 0 0
Local and systemic reactogenicity of UFluA vaccination following one of four dose schedules.
Timepoint [2] 0 0
seven days after each vaccination
Secondary outcome [1] 0 0
Anti-H. pylori ferritin immune response to UFluA vaccination.
Timepoint [1] 0 0
up to 4 weeks after the last vaccination.
Secondary outcome [2] 0 0
Anti-human ferritin immune response to UFluA vaccination.
Timepoint [2] 0 0
up to 4 weeks after the last vaccination.
Secondary outcome [3] 0 0
Humoral immune response to A1 influenza antigen following UFluA vaccination.
Timepoint [3] 0 0
up to 4 weeks after the last vaccination.
Secondary outcome [4] 0 0
Humoral immune response to A2 influenza antigen following UFluA vaccination.
Timepoint [4] 0 0
up to 4 weeks after the last vaccination.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2023
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Emergent BioSolutions
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James McCarthy, MD
Address 0 0
Emergent BioSolutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05155319