Vaccine for Prevention of Bird Flu

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 during the first 28 weeks after enrollment in the study.
• •Subject has received any of the following substances:
• •2. Systemic immunosuppressive medications or cytotoxic medications, within the 12 weeks prior to enrollment. \[With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
• •3. Blood products within 112 days (16 weeks) prior to HIV screening
• •4. Immunoglobulin within 56 days (8 weeks) prior to HIV screening
• •5. Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration
• •6. Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration
• •7. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) of initial study vaccine administration
• •8. Current anti-TB prophylaxis or therapy
• •9. Previous H5 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 (e.g., egg allergy)
• •11. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
• •12. Hereditary angioedema (HAE), acquired angioedema (AAE), 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 by medication or is more than 145/95 at enrollment.
• •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. Allergic reaction to aminoglycoside antibiotics.
• •23. Guillain-Barr 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.