H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...

This is an interventional prevention trial for Influenza focused on measuring A/Anhui/1/2013 (H7N9), Antibody Response, Avian Influenza, A/Shanghai/2/2013 (H7N9), Immunogenicity Read More

• INCLUSION CRITERIA:

A subject must meet all of the following criteria:

1. 18 to 60 years old.
2. Available for clinic visits for up to 28 weeks after enrollment.
3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
4. Willing to donate blood for sample storage to be used for future research.
5. In good general health without clinically significant medical history.
6. Received a current seasonal influenza vaccine at least 2 weeks before enrollment.

7. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment.

   Laboratory Criteria within 56 days prior to enrollment:

8. Hemoglobin within institutional normal limits
9. White blood cells (WBC) and differential either within institutional normal range or accompanied by site physician approval
10. Total lymphocyte count greater than or equal to 800 cells/mm3
11. Platelets = 125,000 500,000/mm3
12. Alanine aminotransferase (ALT) less than or equal to 1.25 x upper limit of normal (ULN)

13. Serum creatinine less than or equal to .1 x ULN based on the institutional normal range

    Criteria applicable to women of childbearing potential:

14. Negative human chorionic gonadotropin ( <=-HCG) pregnancy test (urine or serum) on day of enrollment
15. Agree to use an effective means of birth control from 21 days prior to enrollment through 4 weeks after the second study vaccination

EXCLUSION CRITERIA:

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

1. Breast-feeding or planning to become pregnant while participating in 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 initial study vaccine administration
5. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
6. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI)
7. Allergy treatment with antigen injections, unless on maintenance schedule
8. Current anti-TB prophylaxis or therapy

9. Previous H7 avian influenza investigational vaccine

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

10. Contraindication to receiving an FDA-approved current seasonal influenza vaccination including hypersensitivity to eggs
11. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
12. Hereditary angioedema, acquired angioedema, or idiopathic forms of Angioedema
13. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids
14. Diabetes mellitus (type I or II), with the exception of gestational diabetes
15. Thyroid disease that is not well controlled
16. Idiopathic urticaria within the past year
17. Hypertension that is not well controlled
18. 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
19. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study
20. 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
21. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
22. Type 1 hypersensitivity reaction to aminoglycoside antibiotics
23. Guillain-Barr(SqrRoot)(Copyright) Syndrome
24. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt
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 volunteer s ability to give informed consent