VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults

Exclusion Criteria

• •A volunteer will be excluded if one or more of the following conditions apply:
• •Volunteer has received any of the following substances:
• •1. Investigational Marburg vaccine in a prior clinical trial.
• •2. Investigational Ebola vaccine in a prior clinical trial.
• •3. Investigational cAd3 or MVA vaccines in a prior clinical trial.
• •4. Evidence of increased cardiovascular disease risk defined as \>10% five year risk by the non-laboratory method.
• •5. Electrocardiogram (ECG) with clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment.
• •6. Type 1 hypersensitivity reaction to aminoglycoside antibiotics.
• •7. More than 10 days of systemic immunosuppressive medications except for short-term treatments of minor ailments in otherwise healthy volunteers, or cytotoxic medications within the 4 weeks prior to enrollment, or any within the 14 days prior to enrollment.
• •8. Blood products within 112 days (16 weeks) prior to enrollment.
• •9. Investigational research agents within 28 days (4 weeks) prior to enrollment.
• •10. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
• •11. 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) or designee
• •12. Current anti-tuberculosis prophylaxis or therapy.
• •-Female-specific criteria:
• •13. Woman who is breast-feeding or planning to become pregnant during the 24 weeks of study participation.
• •-Volunteer has a history of any of the following clinically significant conditions:
• •14. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• •15. Clinically significant autoimmune disease or immunodeficiency.
• •16. Asthma that is not well controlled.
• •17. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• •18. Thyroid disease that is not well controlled.
• •19. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• •20. Idiopathic urticaria within the last 1 year.
• •21. Hypertension that is not well controlled.
• •22. 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.
• •23. Malignancy that is active or history of a malignancy that is likely to recur during the period of the study.
• •24. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
• •25. Asplenia or functional asplenia.
• •26. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within five years prior to enrollment, history of a suicide plan or attempt.
• •27. 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.