INCLUSION CRITERIA:
A participant must meet all of the following criteria:
1. 18 to 60 years old
2. Available for clinical follow-up through Week 32
3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
4. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly
5. Able and willing to complete the informed consent process
6. Willing to donate blood for sample storage to be used for future research
7. In good general health without clinically significant medical history
8. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment
LABORATORY CRITERIA WITHIN 28 DAYS PRIOR TO ENROLLMENT:
9. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
10. White blood cells (WBC) = 3,300-12,000 cells/mm3
11. Differential either within institutional normal range or accompanied by site physician approval
12. Total lymphocyte count greater than or equal to 800 cells/mm3
13. Platelets = 125,000 - 400,000/mm3
14. Alanine aminotransferase (ALT) less than 1.25 upper limit of normal
15. Serum creatinine less than or equal to 1 x upper limits of normal (less than or equal to1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males)
16. Normal urinalysis defined as negative glucose, negative or trace protein and no clinically significant blood in the urine
17. Negative FDA-approved HIV blood test. [Note: Results of HIV ELISA will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]
18. Negative hepatitis B surface antigen (HBsAg)
19. Negative anti-HCV and negative hepatitis C virus (HCV) PCR
20. Partial thromboplastin time (PTT) within institutional normal range
21. Prothrombin time (PT) less than or equal to upper limit of normal
FEMALE-SPECIFIC CRITERIA:
22. Negative Beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential
23. A female participant must meet one of the following criteria:
- No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
OR
- Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 32 of the study,
OR
- Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 32 of the study by one of the following methods:
a. condoms, male or female, with or without a spermicide
b. diaphragm or cervical cap with spermicide
c. intrauterine device
d. contraceptive pills or patch, Norplant, Depo-Provera or any other FDA-approved contraceptive method
e. male partner has previously undergone a vasectomy
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
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008