Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

• INCLUSION CRITERIA:

Individuals must meet all of the following criteria to be eligible for study participation:

• 18 and = 1 year) or history of hysterectomy or bilateral oophorectomy.
• Agrees to practice abstinence.
• Agrees that, with heterosexual intercourse with a fertile male partner, she will use an acceptable form of contraception and her male partner will use a condom with spermicide. Acceptable effective methods of female contraception include the following: bilateral tubal ligation, implant of levonorgestrel, injectable progestogen, intrauterine device, oral contraceptive pills, and diaphragm with spermicide.
• Able to provide informed consent.
• Able to speak English.
• Human immunodeficiency virus (HIV) uninfected with a negative test within 60 days of enrollment.
• Does not use IN medications (including but not limited to nasal sprays, sinus rinses), over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John s Wort) within 14 days prior to study enrollment, and agrees not to use these mediations through the final study visit, unless approved by the investigator.
• Agrees not to donate blood or blood products from 3 months prior to enrollment through the final study visit.

EXCLUSION CRITERIA

Individuals meeting any of the following criteria will be excluded from study participation:

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression, immune deficiency, or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., Bell s palsy, cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae including GBS.
• Body mass index (BMI) = 35.
• Acute illness within 7 days prior to enrollment.
• Individuals who have grade 2 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
• Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.
• Known allergy to lidocaine or phenylephrine.
• Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
• Receipt of any unlicensed vaccine within 6 months prior to enrollment, not including COVID-19 vaccines under Emergency Use Authorization.
• Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine test for drugs of abuse (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, or tetrahydrocannabinol) prior to vaccination on V1D0.
• Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the principal investigator (PI) to be a contraindication to protocol participation.
• History of angioedema or anaphylaxis.
• History of SARS-COV-2 infection with residual or ongoing symptoms.
• Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the participant s ability to give informed consent.