Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000925640
Ethics application status
Approved
Date submitted
6/08/2023
Date registered
29/08/2023
Date last updated
13/10/2024
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to test the safety of MYNFLU001 Influenza Vaccine in Healthy Adults
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Reactogenicity and Immunogenicity of MYNFLU001 Cell Derived, Adjuvanted, Quadrivalent Influenza Vaccine in Healthy Adults
Secondary ID [1] 308783 0
MYNFLU001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 328734 0
Inflammatory and immune system 328774 0
Condition category
Condition code
Infection 325734 325734 0 0
Other infectious diseases
Inflammatory and Immune System 325735 325735 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mynvax cell derived adjuvanted, Quadrivalent Influenza Vaccine (MYNFLU001)
This study will evaluate a 2-dose (separated by 21 days) schedule of two dose levels of Mynflu001 and placebo, administered by intramuscular injection:
Arm 1: Low Dose Mynflu001 - 12mcg of investigational vaccine
Arm 2: High Dose Mynflu001 - 32mcg of investigational vaccine
Arm 3: Placebo.
The second dose of the study vaccine will be administered to participants 21 days following the first dose. All participants will be followed up for 12 weeks after the initial dose. A suitably qualified member of the research team will administer the injection. The participants' source documentation will be used to monitor adherence to the allocated intervention.
Intervention code [1] 325234 0
Prevention
Intervention code [2] 325235 0
Treatment: Drugs
Comparator / control treatment
Arm 3 of the study will serve as the control arm. Participants in Arm 3 will receive placebo. The composition of the placebo will be intramuscular injection of the equivalent volume of Sepivac SWE squalene oil-in-water emulsion adjuvant. It is composed of water, squalene, and surfactants.
Control group
Placebo

Outcomes
Primary outcome [1] 333583 0
To assess the safety of low dose and high dose Mynflu001, following 1 or 2 doses.

Safety endpoints include but are not limited to the incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs), and changes in laboratory test results (hematology, clinical chemistry, or vital signs measurements. Adverse events will be assessed as defined by CTCAE, Version 5.0. Potential adverse events that may be encountered following administration of the IP include injection site reactions (pain and/or redness) or total body (systemic) reactions such as fatigue, headache and joint stiffness.
Timepoint [1] 333583 0
Incidence, severity, and causality of immediate adverse events (IAE) will be assessed within 30 minutes following each vaccination.

Incidence, severity and causality of AEs, SAEs and solicited reactions will be assessed daily from administration of the first dose to day 85 post-baseline (end of study).

Hematology and clinical chemistry will be assessed pre-dose at screening (Visit 1), at Day 15, Day 36 and at day 85 post-baseline (end of study). Vital signs will be assessed at every on-site visit as follows: Screening/Visit 1, Day 1 pre-and-post dose 1, Day 15, Day 22 pre-and-post dose 2, Day 36 and at day 85 post-baseline (end of study).
Primary outcome [2] 335781 0
To assess the reactogenicity of low dose and high dose Mynflu001, following 1 or 2 doses.
Reactogenicity endpoints include but are not limited to the incidence severity and causality of local and systemic solicited reactions, assessed by changes in temperature and injection site erythema/redness and swelling. Tests used to determine reactogenicity endpoints include changes in temperature assessed with a thermometer, redness and swelling at the injection site assessed with a ruler and a daily reactogenicity eDiary which is completed by participants and is used to assess vomiting, diarrhoea, headache, fatigue, chills, muscle and joint pain.
Timepoint [2] 335781 0
The incidence, severity, and causality of local and systemic solicited reactions will be assessed for 7 days following each vaccination (Day 1 - Day 8 and again from Day 22 to Day 29).
Secondary outcome [1] 417809 0
To assess the immunogenicity of a two-dose schedule of Mynflu001 through measurement of Geometric Mean Ratio (GMR) in blood.
Timepoint [1] 417809 0
Blood sampling for immunogenicity will be collected pre-dose on Day 1, on Day 15, pre-dose on Day 22, on Day 36 and at Day 85 (end of study).
Secondary outcome [2] 425599 0
To assess the immunogenicity of a two-dose schedule of Mynflu001 through measurement of Geometric Mean Titer (GMT) of Haemagglutination Inhibition antibodies in blood.
Timepoint [2] 425599 0
Blood sampling for immunogenicity will be collected pre-dose on Day 1, on Day 15, pre-dose on Day 22, on Day 36 and at Day 85 (end of study).
Secondary outcome [3] 425600 0
To assess the immunogenicity of a two-dose schedule of Mynflu001 through measurement of Seroconversion Rate (SCR) and Seroprotection Rate (SPR) in blood.
Timepoint [3] 425600 0
Blood sampling for immunogenicity will be collected pre-dose on Day 1, on Day 15, pre-dose on Day 22, on Day 36 and at Day 85 (end of study).

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent.
2. Healthy participants as established by medical history, laboratory examination, physical examination and vital signs during screening and as per the clinical judgment of the investigator.
3. Body Mass Index (BMI) within the range 18 to 35 kg/m2 (inclusive)
4. Women of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1, and must agree to remain sexually abstinent, use medically effective contraception, or have a partner who is sterile or same-sex, from Screening until at least 90 days after the 2nd vaccination. Females with natural amenorrhea for <2 years (without an alternative medical cause) and who are not surgically sterile, i.e. tubal ligation, bilateral oophorectomy, or complete hysterectomy will only be considered not to be of childbearing potential if they have a documented follicle- stimulating hormone (FSH) value in the postmenopausal range.
5. Sexually active male participants who are considered sexually fertile must agree to use either a barrier method of contraception from the time of 1st vaccination until at least 90 days after the 2nd vaccination, or have a same-sex partner, or have a partner who is permanently sterile or unable to become pregnant;
6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
1. Receipt of Inactivated Influenza Vaccine in the past 3 months
2. Fever (oral temperature greater than or equal to 37.5ºC) or any other respiratory symptoms/illnesses within 3 days of vaccine administration
3. Current active viral or bacterial infection
4. Individuals with history of any major pulmonary, cardiovascular, renal, neurological,
metabolic, gastrointestinal, hepato-biliary, blood dyscrasia, uncontrolled hypertension and
diabetes, clinically significant chronic pulmonary disease, asthma, or any condition which in
the opinion of the Investigator might interfere with the evaluation of the study objectives
5. Pregnant or lactating women or willingness/intention to become pregnant during the study
6. Women of child-bearing potential not agreeing to use adequate contraception during the study.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection
8. Severely immunocompromised participants. This exclusion category comprises a) participants with known infection by the human immunodeficiency virus (HIV); b) participants with solid organ transplantation; c) participants with bone marrow transplantation; d) participants under chemotherapy/radiotherapy; e) participants with primary immunodeficiency; g) treatment with any anti-cytokine therapies. h) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks
9. Receipt of blood/plasma products or immunoglobulin, within 60 days before study intervention administration or any planned receipt during the study duration
10. History of solid or non-solid malignancy or lymphoma (except basal cell carcinoma of the skin and cervical carcinoma in situ)
11. Personal or family history of Guillain-Barré syndrome
12. History of allergy or serious adverse reactions to the vaccine components, such as urticaria, dyspnoea, and angioedema
13. Known infection with hepatitis C virus (HCV), or hepatitis B virus (HBV)
14. Clinically significant abnormal laboratory finding on screening hematology and clinical chemistry
15. Eczema or other significant skin lesion or infection at the site/s of injection
16. Receipt of any non-Influenza vaccine or planned receipt of any non-Influenza vaccine within the period of study enrolment to 4 weeks after the second study vaccination dose.
17. Prior receipt of any investigational drugs or non-Influenza vaccines = 30 days before enrolment
18. Any other medical condition, including moderate or severe acute infection on the day of
vaccination which in the opinion of the Investigator may affect the participant’s safety or study participation and conduct.

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)
Participants will be randomly assigned to the Low Dose, High Dose, or Placebo treatment arms at a ratio of 1:1:1 through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central blocked randomization will be utilised. Sequence generation will be done by the independent statistician using a secure web-based randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2023
Actual
29/11/2023
Date of last participant enrolment
Anticipated
31/08/2024
Actual
10/04/2024
Date of last data collection
Anticipated
3/07/2024
Actual
4/07/2024
Sample size
Target
45
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23847 0
University of the Sunshine Coast Clinical Trials Centre - Health Hub Morayfield - Morayfield
Recruitment postcode(s) [1] 39303 0
4506 - Morayfield

Funding & Sponsors
Funding source category [1] 313000 0
Commercial sector/Industry
Name [1] 313000 0
Mynvax Pty. Ltd.
Country [1] 313000 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mynvax Pty. Ltd.
Address
58 Gipps Street, Collingwood, 3066 Victoria, Australia
Country
Australia
Secondary sponsor category [1] 314684 0
None
Name [1] 314684 0
None
Address [1] 314684 0
Country [1] 314684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312263 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 312263 0
Ethics committee country [1] 312263 0
Australia
Date submitted for ethics approval [1] 312263 0
29/11/2022
Approval date [1] 312263 0
07/06/2023
Ethics approval number [1] 312263 0
2022/PID06574

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

Contacts
Principal investigator
Name 124034 0
Dr Christopher Moller
Address 124034 0
University of the Sunshine Coast Clinical Trials
Level 1 Health Hub Morayfield
19-31 Dickson Road
Morayfield QLD 4506
Country 124034 0
Australia
Phone 124034 0
+61 7 5409 8640
Fax 124034 0
Email 124034 0
[email protected]
Contact person for public queries
Name 124035 0
Greg Plunkett
Address 124035 0
Accelagen Pty Ltd
Suite 2.02, 785 Toorak Road
Hawthorn East, VIC 3123
Country 124035 0
Australia
Phone 124035 0
+61 3 9114 2270
Fax 124035 0
Email 124035 0
[email protected]
Contact person for scientific queries
Name 124036 0
Christopher Moller
Address 124036 0
University of the Sunshine Coast Clinical Trials
Level 1 Health Hub Morayfield
19-31 Dickson Road
Morayfield QLD 4506
Country 124036 0
Australia
Phone 124036 0
+61 7 5409 8640
Fax 124036 0
Email 124036 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.