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

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.

What this study is about