Safety Study of Avian Flu Vaccine

Exclusion Criteria

• •A volunteer will be excluded if one or more of the following conditions apply.
• •Women Specific:
• •1. Breast-feeding or planning to become pregnant during the study.
• •Volunteer has received any of the following substances:
• •2. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. \[With the exceptions that use of corticosteroid nasal spray for rhinitis; topical corticosteroids for an acute uncomplicated dermatitis; short-acting beta-agonist use in controlled asthmatics; or a short course (10 days or less) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
• •3. Blood products within 120 days prior to HIV screening.
• •4. Immunoglobulin within 60 days prior to HIV screening.
• •5. Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• •6. Investigational research agents within 30 days 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 of study vaccine administration.
• •8. Current anti-TB prophylaxis or therapy.
• •9. Previous H5 avian influenza investigational vaccine.
• •Volunteer has a history of any of the following clinically significant conditions:
• •10. Autoimmune disease or immunodeficiency.
• •11. Contraindication to receiving an FDA approved 2006-2007 seasonal influenza vaccination (e.g., egg allergy).
• •12. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• •13. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• •14. 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.
• •15. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• •16. History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• •17. Idiopathic urticaria within the past 2 years.
• •18. Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• •19. 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.
• •20. 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.
• •21. Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
• •22. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
• •23. Allergic reaction to aminoglycoside antibiotics.
• •24. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five 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.