Eligibility Details:
- INCLUSION CRITERIA:
1. Healthy adults between the ages of 18-70 years inclusive
2. Based on history and examination, in good general health and without history of
any of the conditions listed in the exclusion criteria
3. Received at least one licensed influenza vaccine from 2014 to the present
4. Able and willing to complete the informed consent process
5. If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment
and through an influenza season
6. If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks
after enrollment and through an influenza season
7. Willing to have blood samples collected, stored indefinitely, and used for
research purposes
8. Able to provide proof of identity to the satisfaction of the study clinician
completing the enrollment process
9. Physical examination and laboratory results without clinically significant
findings and a Body Mass Index (BMI) less than or equal to 40 within the 28 days
before enrollment
Laboratory Criteria within 28 days before enrollment
10. White blood cells (WBC) and differential either within institutional normal range
or accompanied by the site Principal Investigator (PI) or designee approval
11. Total lymphocyte count greater than or equal to 800 cells/mm^3
12. Platelets = 125,000 - 500,000/mm3
13. Hemoglobin within institutional normal range
14. Serum iron either within institutional normal range or accompanied by the site PI
or designee approval
15. Serum ferritin within institutional normal range or accompanied by the site PI or
designee approval
16. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper
limit of normal (ULN)
17. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
18. Alkaline phosphatase (ALP) <1.1 x institutional ULN
19. Total bilirubin within institutional normal range
20. Serum creatinine less than or equal to 1.1 x institutional ULN
21. Negative for HIV infection by an FDA-approved method of detection
Criteria applicable to women of childbearing potential:
22. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or
serum) on the day of enrollment
23. Agrees to use an effective means of birth control from at least 21 days prior to
enrollment through the end of the study
EXCLUSION CRITERIA:
1. Breast-feeding or planning to become pregnant during the study.
Subject has received any of the following substances:
2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications
within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
3. Blood products within 16 weeks prior to enrollment
4. Live attenuated vaccines within 4 weeks prior to enrollment
5. Inactivated vaccines within 2 weeks prior to enrollment
6. Investigational research agents within 4 weeks prior to enrollment or planning to
receive investigational products while on the study
7. Current allergy treatment with allergen immunotherapy with antigen injections, unless
on maintenance schedule
8. Current anti-TB prophylaxis or therapy
9. Previous investigational H1 influenza vaccine
10. Previous investigational ferritin-based vaccine
11. Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment
Subject has a history of any of the following clinically significant conditions:
12. Serious reactions to vaccines that preclude receipt of study vaccinations as
determined by the investigator
13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
14. Asthma that is not well controlled
15. Diabetes mellitus (type I or II), with the exception of gestational diabetes
16. Thyroid disease that is not well controlled
17. Idiopathic urticaria within the past year
18. Autoimmune disease or immunodeficiency
19. Hypertension that is not well controlled (baseline systolic > 140 mmHg or diastolic >
90 mmHg)
20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or
platelet disorder requiring special precautions) or significant bruising or bleeding
difficulties with IM injections or blood draws
21. Malignancy that is active or history of malignancy that is likely to recur during the
period of the study.
22. Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol
withdrawal more than 3 years ago, or 3) seizures that have not required treatment
within the last 3 years
23. Asplenia, functional asplenia or any condition resulting in the absence or removal of
the spleen
24. Guillain-Barr(SqrRoot)(Copyright) Syndrome
25. Any medical, psychiatric, social condition, occupational reason or other
responsibility that, in the judgment of the investigator, is a contraindication to
protocol participation or impairs a subject s ability to give informed consent.