Immune Response Following Seasonal Influenza Vaccination

Exclusion Criteria

• •1. Pregnant, possibly pregnant, or lactating women
• •2. Body mass index\> 35.0 kg/m2
• •3. Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
• •4. Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
• •* Daily symptoms
• •* Daily use of short acting beta 2 agonists
• •* Use of inhaled steroids or theophylline
• •* Use of pulse systemic steroids
• •* Emergency care or hospitalization related to asthma or other chronic lung disease
• •* Systemic steroids for asthma exacerbation
• •5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
• •6. History of coronary artery disease, arrhythmia, or congestive heart failure
• •7. Clinically significant ECG abnormality
• •8. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or pre-dose on Day I
• •9. History of anaphylaxis or angioedema
• •10. Known allergy to any of the ingredients in the vaccine formulation including egg allergy
• •11. History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
• •12. Previous nasal surgery or nasal cauterization
• •13. Any symptoms of upper respiratory infection or temperature\> 38°C within 3 days before Day I
• •14. Significant nasal congestion or rhinorrhea as assessed by the investigator.
• •15. Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
• •16. Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
• •17. Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)
• •18. Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
• •19. Receipt of any IP within 30 days before Day 1
• •20. Receipt of any vaccine within 30 days before Day I
• •21. Receipt of intranasal vaccine within 90 days before Day I
• •22. Receipt of any influenza vaccine within 6 months before Day I
• •23. Any change in medication for a chronic medical condition within 30 days before Day I
• •24. Past regular use or current use of intranasal illicit drugs or any regular use of illicit drugs by any other route.
• •25. Use of tobacco products or electronic cigarettes within 30 days before Day l. Any other smoking products including marijuana will be excluded.
• •26. Any medical, psychiatric, or social condition or any occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including immunogenicity), or a subject's ability to give informed consent