Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults

This is an interventional prevention trial for Influenza focused on measuring Flu Virus, Flu Shot, H2N2, Protein, Immune Response Read More

INCLUSION CRITERIA:

A subject must meet all of the following criteria:

• Healthy subjects aged 18-70 (excluding subjects born between 1966-1969)
• Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria
• Received at least one licensed current seasonal influenza vaccine from 2014 to the present
• Able and willing to complete the informed consent process
• Available for clinic visits for 40 weeks after enrollment
• Willing to have blood samples collected, stored indefinitely, and used for research purposes
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 84 days before enrollment

Laboratory Criteria within 84 days before enrollment:

• White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
• Total lymphocyte count greater than or equal to 800 cells/mm^3
• Platelets = 125,000 - 500,000/mm^3
• Hemoglobin within institutional normal range
• Serum iron either within institutional normal range or accompanied by the site PI or designee approval
• Alanine aminotransferase (ALT) less than or equal to 1.25 times institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) less than or equal to 1.25 times institutional ULN
• Alkaline phosphatase (ALP) less than or equal to 1.1 times institutional ULN
• Total bilirubin within institutional ULN
• Serum creatinine less than or equal to 1.1 times institutional ULN
• Negative for HIV infection by an FDA approved method of detection

Criteria applicable to women of childbearing potential:

• Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment
• 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:

A subject will be excluded if one or more of the following conditions apply:

- Breast-feeding or planning to become pregnant during the study.

Subject has received any of the following substances:

• 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
• Blood products within 16 weeks prior to enrollment
• Live attenuated vaccines within 4 weeks prior to enrollment
• Inactivated vaccines within 2 weeks prior to enrollment.
• Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
• Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
• Current anti-tuberculosis (TB) prophylaxis or therapy
• Previous H2 influenza investigational vaccine
• Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment

Subject has a history of any of the following clinically significant conditions:

• Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
• Asthma that is not well controlled
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• Thyroid disease that is not well controlled
• Idiopathic urticaria within the past year
• Evidence of autoimmune disease or immunodeficiency
• Hypertension that is not well controlled
• 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
• Malignancy that is active or history of malignancy that is likely to recur during the period of the study.
• 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
• Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
• Guillain-Barre Syndrome
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt
• 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.