First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP

Inclusion Criteria:

1. Healthy adult male or female subject between 18 and 40 years of age at the time ofinformed consent.

2. Subject who is fully informed of and understands the objectives, procedures,anticipated side effects of the vaccine and risks of the study and who voluntarilyprovides written consent to participate in the study.

3. Subject's body weight is equal to or more than 50 kg, and body mass index is atleast 18 kg/m2 but no more than 30 kg/m2 at screening.

4. Subject willing and able to comply with the study requirements, including laboratorytests and reporting symptoms.

5. A male subject with a female partner of childbearing potential must agree to useadequate and reliable contraception (e.g., using condom or have had vasectomy withproven sterility for male and using contraceptive agents, diaphragm, intrauterinedevices (IUDs), or bilateral tubal ligation for female partner) from informedconsent until at least 30 days after last administration of the study vaccine.

6. A female subject is eligible for this study if she is neither pregnant norbreastfeeding and 1 of the following:

7. Of non childbearing potential (i.e., women who have had a hysterectomy or tuballigation or are postmenopausal, as defined by no menses in greater than orequal to 1 year).

8. Of childbearing potential but has been and agrees to continue practicing highlyeffective contraception from informed consent until at least 30 days after thelast administration. Highly effective methods of contraception include 1 ormore of the following:

• a female subject who is abstinent or have a sexual relationship with solefemale partner;
• male partner who is sterile (vasectomized) prior to the female subject'sentry into the study and is the sole sexual partner for the femalesubject;
• hormonal (oral, intravaginal, transdermal, implantable or injectable),which is associated with inhibition of ovulation;
• an intrauterine hormone-releasing system;
• an intrauterine device with a documented failure rate of < 1%;
• bilateral tubal occlusion.

7. A female subject who is premenopausal and of childbearing potential must have anegative urine pregnancy-test result at screening, on Days 1 and 22.

8. Subject must agree not to donate sperm or eggs from informed consent until at least 30 days after last administration of the study vaccine.

Exclusion Criteria:

1. Subject with a history of clinically significant cardiovascular, hepatic, renal,endocrine, gastrointestinal, hematological, respiratory, psychiatric or neurologicdisease, and who is considered ineligible for the study by the PrincipalInvestigator (PI) or sub Investigator.

2. Subject with other medical or psychiatric condition including recent (within thepast year) or active suicidal ideation/behavior that may increase the risk of studyparticipation or, in the Investigator's judgement, make the subject inappropriatefor the study.

3. Subject immunocompromised with known or suspected immunodeficiency, as determined byhistory and/or laboratory/physical examination.

4. Subject with a history or evidence of autoimmune disease or known immunodeficiencyof any cause or severe allergy.

5. Subject who receives chronic treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmunedisease, within 60 days before the Screening Visit or planned receipt throughout thestudy. If systemic corticosteroids have been administered short term (< 14 days) fortreatment of an acute illness, subjects should not be enrolled into the study untilcorticosteroid therapy has been discontinued for at least 28 days before firstadministration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin oreyes) corticosteroids are permitted.

6. Subject with a history of severe adverse reaction associated with a vaccine and/or aknown or suspected allergic reaction (e.g., anaphylaxis) or hypersensitivity to anycomponent of the investigational product including egg protein.

7. Subject with a history of substance abuse or drug abuse. If there is any doubt aboutthe correctness of the information provided by the subject (history) or observationof a behavior that raises concerns about drug use, drug screening will be conductedat the Screening Visit or prior to first administration.

8. Subject with a positive serology (hepatitis B surface antigen, hepatitis C antibody,human immunodeficiency virus antigen/antibody) at screening.

9. Subject with any clinically significant abnormal clinical laboratory value (hematology, serum chemistry, urinalysis, coagulation) determined by the PI orsub-Investigator at screening.

10. Subject with a history of excessive alcohol consumption (defined as drinking atleast 21 units of alcohol beverage per week for a man and 14 units of alcoholbeverage per week for a woman) within 6 months of the Screening Visit. Followingcommon drinks contain 1 unit of alcohol: 300 ml beer [4% alcohol by volume (ABV)], 100 ml of wine (12% ABV), 30 ml of spirits (40% ABV).

11. Subject who drinks large quantities of caffeinated beverages (coffee, tea, greentea, cola, tonic drink, etc) (approximately 1.8 L daily or more).

12. Subject with a history of tobacco (including electronic cigarette) dependency orsubject who smokes ≥ 20 cigarettes daily (excluding subject who stopped smoking morethan 2 years ago).

13. Subject who has received seasonal flu vaccine within a year prior to the ScreeningVisit.

14. Subject who has experienced significant blood loss or donated blood (≥ 400 mL)within 90 days prior to the first administration or donated 200 mL of blood or morewithin 30 days prior to the first administration; has donated blood componentswithin 14 days prior to the first administration.

15. Subject who has received blood/plasma products or immunoglobulins within 6 monthsprior to the Screening Visit.

16. Subject who has received any investigational drug or who is currently participatingor has participated in a clinical study within 90 days prior to the Screening Visit.

17. Subject who has participated in a clinical study of any influenza vaccine, or anyinvestigational vaccine or experimental influenza viral challenge delivered directlyto the respiratory tract within a year prior to the first administration.

18. Subject with a history of hospitalization (excluding hospitalization for medicalcheckup) for at least one night within 45 days prior to the Screening Visit.

19. Subject who has used prescription or over-the-counter medications except chronicmedication and contraceptives for female subjects within 7 days or 5 half-livesprior to the first administration.

20. In the Investigator's judgement, the subject has current symptoms suggestive of anacute infection, or presence of long-term medical, neurologic, or psychiatricsequalae of prior COVID-19.

21. Subject who has received any other licensed vaccine within 28 days prior toscreening or who is planning to receive any vaccine up to 28 days after the lastvaccine administration.

22. Subject who is a staff member of the clinical site/Sponsor/Contract researchorganization (CRO) or the relative of a staff member.

23. Subject who is in the opinion of the PI or sub-Investigator, unsuitable in any otherway to participate in this study.

24. Subject with bleeding disorder that would, in the opinion of the Investigator,contraindicate IM injection.