A study to test the safety of MYNFLU001 Influenza Vaccine in Healthy Adults
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
Mynvax Pty. Ltd.
45 participants
Nov 29, 2023
Interventional
Conditions
Summary
The purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination) and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of an influenza vaccine, MYNFLU001. The MYNFLU001 vaccine will be administered twice via intramuscular injection, 21 days apart. This study will be conducted on healthy men or women, 18-59 years old. This study will compare MYNFLU001 with placebo. A placebo has no active drug in it. One group of participants will receive a low dose of the vaccine (12mcg), one group will receive the high dose (32mcg) and the other group will receive a placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve 15 participants, with 45 participants to be enrolled in total.
Eligibility
Inclusion Criteria7
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 18 to 59 years of age inclusive, at the time of signing the informed consent.
- 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.
- Body Mass Index (BMI) within the range 18 to 35 kg/m2 (inclusive)
- 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.
- 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;
- 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.
Exclusion Criteria23
- Participants are excluded from the study if any of the following criteria apply:
- Receipt of Inactivated Influenza Vaccine in the past 3 months
- Fever (oral temperature greater than or equal to 37.5ºC) or any other respiratory symptoms/illnesses within 3 days of vaccine administration
- Current active viral or bacterial infection
- 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
- Pregnant or lactating women or willingness/intention to become pregnant during the study
- Women of child-bearing potential not agreeing to use adequate contraception during the study.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection
- 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
- Receipt of blood/plasma products or immunoglobulin, within 60 days before study intervention administration or any planned receipt during the study duration
- History of solid or non-solid malignancy or lymphoma (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- Personal or family history of Guillain-Barré syndrome
- History of allergy or serious adverse reactions to the vaccine components, such as urticaria, dyspnoea, and angioedema
- Known infection with hepatitis C virus (HCV), or hepatitis B virus (HBV)
- Clinically significant abnormal laboratory finding on screening hematology and clinical chemistry
- Eczema or other significant skin lesion or infection at the site/s of injection
- 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.
- Prior receipt of any investigational drugs or non-Influenza vaccines = 30 days before enrolment
- 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.
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Interventions
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.
Locations(1)
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ACTRN12623000925640