BARDA BP-I-23-001 H5 Influenza

Inclusion Criteria:

1. Male or non-pregnant female, 18 years of age or older at the time of screening andinformed consent.

2. Willing and able to provide written informed consent prior to initiation of studyprocedures.

3. Agrees to have specimens collected during this trial specifically for the purpose offuture research stored for future research use.

4. In relatively stable health, as determined by medical history and physicalexamination. a. Any chronic medical diagnoses or conditions should be stable and well managed,with no significant changes expected during the study period, and in the opinion ofthe site investigator, will not impact the ability to assess safety and/orimmunogenicity per the study design.

5. If a female of childbearing potential who is sexually active, agrees to use anadequate method of birth control from Screening through 4 weeks following the laststudy vaccination and has used an adequate birth control method for at least 2months prior to Screening. a. Female of childbearing potential is defined as post onset menarche andpre-menopausal person capable of becoming pregnant. This does not include femaleswho meet any of the following conditions: i. menopausal >2 years ii. tubal ligation >1 year iii. bilateral salpingo-oophorectomy iv. hysterectomy. b. Adequate contraception is defined as a contraceptive method with a failure rateof less than 1% per year when used consistently and correctly and when applicable,in accordance with the product label, for example: oral contraceptives, eithercombined or progestogen alone; injectable progestogen; implants of etonogestrel orlevonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches;intrauterine device or intrauterine system; the female participant has exclusivelyfemale sexual partners; male partner is sterile or otherwise unable to produce sperm (information on the person's sterility can come from the site personnel's review ofthe participant's medical records or interview with the participant regarding hermedical history); male condom combined with a vaginal spermicide (foam, gel, film,cream, or suppository); or male condom combined with a female diaphragm, either withor without a vaginal spermicide (foam, gel, film, cream, or suppository).

6. Available for all study visits, willing to participate in all study procedures, andnot planning to relocate from the area for the duration of the study.

Exclusion Criteria:

1. Has an acute illness, as determined by the site investigator, within 72 hours priorto vaccination. a. An acute illness that is nearly resolved, with only minor residual symptomsremaining, is allowable if, in the opinion of the site investigator, the residualsymptoms will not interfere with the ability of study staff to assess safetyparameters as required by the protocol.

2. Has a history of severe reaction to any influenza vaccine.

3. Has a known allergy to squalene-based adjuvants.

4. Female of childbearing potential who has a positive urine pregnancy test or who iscurrently breastfeeding.

5. Has a body mass index >35 kg/m2 .

6. Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection (basedon medical history).

7. Has a history of any pIMDs (list provided in Protocol Appendix 3), neuralgia,paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior toScreening, or a family history of Guillain-Barré syndrome.

8. Has narcolepsy or a first degree relative with narcolepsy.

9. Has a history of alcohol or drug abuse within 5 years prior to Screening.

10. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any otherpsychiatric diagnosis that may, in the opinion of the site investigator, interferewith participant compliance or safety evaluations.

11. Is immunosuppressed due to an underlying disease or medication, use of anticancerchemotherapy (cytotoxic), or radiation therapy.

12. With the exception of basal or squamous cell skin cancer, has known activeneoplastic disease, including hematologic malignancy.

13. Has long-term use (≥14 consecutive days) of glucocorticoids including oral orparenteral prednisone or prednisone equivalent (>20 mg total dose per day) orhigh-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate orequivalent) within 1 month prior to screening in this study. However, participantson low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate orequivalent) or topical steroids are not excluded.

14. Has received immunoglobulin or other blood product (with the exception of Rho[D]immune globulin) within the 90 days prior to screening in this study.

15. Has received any (licensed or under Emergency Use Authorization [EUA]) live vaccineswithin 4 weeks or inactivated, messenger RNA (mRNA), or recombinant protein vaccineswithin 2 weeks prior to screening, or plans to receive such vaccines (includingseasonal influenza and COVID-19 vaccines) from screening through 22 days followingthe second dose of the study vaccine, inclusive of the vaccination day (ScreeningVisit through Day 43).

16. Is participating or plans to participate in another interventional clinical trial (either active or follow-up phase) during the study period.

17. Has participated in an A(H5) influenza vaccine study in the past or has a history ofA(H5) influenza infection prior to vaccination in this study. This includes, but isnot limited to, influenza sub-types A(H5N1), A(H5N8), and A(H5N6).

18. Has any laboratory test result or clinical findings (including vital signs) thatsingly or in combination are likely to unfavorably alter the risks of participantparticipation or to confound study safety or immunogenicity results, in the opinionof the site investigator. Additionally, the following are exclusionary:

19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times theupper limit of normal (ULN), or

20. Bilirubin >1.5 times the ULN unless isolated Gilbert's syndrome.

21. Has any disease or medical condition that, in the opinion of the site investigator,might confound interpretation of safety or immunogenicity.