Ebola and Marburg Virus Vaccines

Exclusion Criteria

• •A SUBJECT WILL BE EXCLUDED IF ONE OR MORE OF THE FOLLOWING CONDITIONS APPLY:
• •Women:
• •1. Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment
• •SUBJECT HAS RECEIVED ANY OF THE FOLLOWING SUBSTANCES:
• •2. Investigational Ebola vaccine in a prior clinical trial
• •3. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the 12 weeks prior to enrollment. \[With the exceptions that use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
• •4. Blood products within 120 days prior to HIV screening
• •5. Immunoglobulin within 60 days prior to HIV screening
• •6. Live attenuated vaccines within 30 days prior to initial study vaccine administration
• •7. Investigational research agents within 30 days prior to initial study vaccine administration
• •8. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• •9. Current anti-tuberculosis prophylaxis or therapy
• •SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:
• •10. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
• •11. Idiopathic urticaria within the past 2 years
• •12. Autoimmune disease or immunodeficiency
• •13. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that requires the use of oral or parenteral corticosteroids
• •14. Diabetes mellitus (type I or II), with the exception of gestational diabetes
• •15. History of thyroidectomy or thyroid disease that required medication within the past 12 months
• •16. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
• •17. Hypertension that is not well controlled by medication or blood pressure that 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), significant bruising or bleeding difficulties with IM injections or blood draws, or routine use of anticoagulant medications
• •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 under the age of 2 years, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring 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. 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
• •24. 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
• •Eligibility for the Optional 4th Study Injection:
• •Eligibility to receive a 4th injection requires the original consent (Appendix I) to be reviewed again with a study clinician, as well as the consent for the optional 4th injection (Appendix V) to be reviewed and signed. To be eligible the study subject must meet the following criteria:
• •Has completed the 3-injection schedule for the Group in which he/she was enrolled.
• •Has remained in follow-up through Study Week 32 without any serious adverse events.
• •Meets the original study eligibility criteria for hemoglobin, platelets. PT. PTT. Creatinine and ALT within the 28 days prior to the 4th injection.
• •Assessed as continuing to have a healthy vaccine study volunteer status by recent interim history and appropriate physical assessments.
• •If a woman of reproductive potential, is willing to continue with a pregnancy prevention method (from among those meeting the original study eligibility) through 12 weeks after the injection and is confirmed as not pregnant on the day of the 4th injection prior to administration of the injection.
• •Available for clinical follow-up through 12 weeks after the 4th injection.