| Eligibility |
Inclusion Criteria:
1. Subject must be able to read and provide consent after completing the informed consent
process.
2. Subject must be able to understand and comply with planned procedures.
3. Subject must be a man or woman aged > / = 18 to < / = 45 years.
4. Subject must have a body mass index (BMI) > / = 18.5 and < 35 kg/m^2.
5. Subject must be healthy on the basis of patient-reported medical history, physical
examination, and the investigator's clinical judgment.
6. Subject must have acceptable laboratory parameters* within 28 days of enrollment:
- Note 1: If the following acceptable screening laboratory parameters** are out of
range, repeat of screening tests is permitted once, provided there is an
alternative explanation for the out of range value. The alternative explanation
for the out of range value should be documented in the subject's source
documents. The acceptable value for repeated screening tests must be available
within the 28 days screening period.
Acceptable laboratory parameters include the following:
- Hemoglobin: women: > / = 11.5 g/dL; men > / = 12.5 g/dL
- White blood cell (WBC) count: > 3.7 Thousand/uL but < 10.9 Thousand/uL
- Absolute neutrophil count > 1,500 cells/uL
- Platelets: > 139 but < 550 Thousand/uL
- Urinalysis (clean urine sample)*: protein and blood < 1+, glucose negative *Note: for
women: in case of menstruation, urinalysis must be postponed, but a result should be
available before Day 1.
- Alanine aminotransferase (ALT) < / = 1 x institutional upper limit of normal
- Serum creatinine < / = 1 x institutional upper limit of normal
- Troponin I < / = 1 x institutional upper limit of normal
- Fibrinogen > 140 mg/dL but < / = 500 mg/dL
- Prothrombin time (PT) < / = 1 x institutional upper limit of normal
- Activated partial thromboplastin time (PTT) < / = 1 x institutional upper limit of
normal.
- Negative test for HIV.
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
- Note 2: Grade 1 abnormalities for laboratory tests other than those covered in
this list are considered acceptable if not clinically significant. If a Grade 2
or Grade 3 abnormality for lab tests other than those covered in this list is
identified, repeating the screening tests is permitted once provided there is an
alternative explanation for the out-of-range value. The alternative explanation
for the out of range value should be documented in the subject's source
documents.
7. Women of childbearing potential must have a negative serum pregnancy test
during screening and a negative urine pregnancy test immediately prior to each
study vaccine administration.
8. Women of childbearing potential must have an acceptable method of
contraception* from 28 days before the prime vaccination until at least 3 months
after the last boost vaccination.
*Acceptable methods of birth control include the following:
a. Prescription oral contraceptives, contraceptive injections, intrauterine
device (IUD), implants, vaginal ring, double-barrier method, contraceptive patch,
male partner sterilization b. Abstinence (defined as refraining from heterosexual
intercourse) c. If not heterosexually active at screening, must agree to practice
adequate birth control measures if they become heterosexually active from the
start of screening onwards until at least 3 months after the last boost
vaccination.
d. Women of non-childbearing potential, defined as postmenopausal (any age with
amenorrhea for > / = 6 months and serum follicle-stimulating hormone [FSH] > 40
mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or
bilateral oophorectomy), are not required to use the required birth control
methods.
9. Female subject agrees to not donate eggs (ova, oocytes) for the purposes of
assisted reproduction from the start of screening onwards until at least 3 months
after the last boost vaccination.
10. Male subject who has not had a vasectomy and is sexually active with a woman
of childbearing potential must agree to use an acceptable method* of birth
control until at least 3 months after the last boost vaccination.
*Acceptable methods of birth control include the following:
1. A double-barrier method of birth control, such as condom and partner with
occlusive cap (diaphragm, cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository.
2. In case the female partner is using an adequate method of birth control (see
Inclusion Criterion #8), a single barrier method of birth control for the
male subject is acceptable.
11. Male subject must also agree not to donate sperm for the purposes of
assisted reproduction from the start of screening onwards until at least 3
months after the last boost vaccination.
12. Subject must be available and willing to participate for the duration of
the study visits and follow-up (up to 19 months from enrollment).
13. Subject must provide identification. 14. Subject must have a means to be
contacted. 15. Subjects must have consistent access to the internet to
perform electronic data entry.
Exclusion Criteria:
1. Has been vaccinated with an Ebola vaccine.
2. Has been diagnosed with Ebola disease, or exposed to Ebola including
travel to West Africa* in 2014-2016.
- Note: West Africa includes but is not limited to the countries of
Guinea, Liberia, Mali, and Sierra Leone. Subjects who anticipate
traveling to epidemic Ebola areas before the end of the study will
also be excluded from enrollment into the study.
3. Known or suspected receipt of an adenovirus serotype 26 (Ad26)-based
vaccine.
4. Known or suspected receipt of any licensed or investigational small pox
(vaccinia)-based vaccine* *Note: Includes any MVA-based candidate
vaccine (Imvamune or Imvanex), Dryvax, or Acam2000. Military history
should be reviewed with potential subjects for receipt of
vaccinia-based vaccine. The presence of a typical vaccinia scar should
be considered exclusionary.
5. Positive serology for human immunodeficiency virus (HIV)
6. Positive Hepatitis B surface antigen
7. Positive antibody to Hepatitis C virus (HCV)
8. Known allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or vaccine products*.
*Note: This includes a known allergy to egg, egg products and
aminoglycosides or any of the constituents of the study vaccines [e.g.,
polysorbate 80, ethylenediaminetetraacetic acid (EDTA), L-histidine,
tris (hydroxymethyl)-amino methane (THAM)).
9. Has an acute illness or temperature > / = 38.0 degrees Celsius within
the 3 days prior to Day 1.* *Note: Potential subjects can be
rescheduled due to acute illness within the 28 day window between
screening and enrollment. If acute illness prevents administration of
vaccine within the 28 day screening window, the potential subject can
be enrolled once the acute illness resolves after repeating safety
laboratories and if the subject is otherwise eligible. The ECG does not
need to be repeated as it is not a safety laboratory and unlikely to
change without clinical event in this age group of volunteers.
10. Female subject is pregnant or breast-feeding, or planning to become
pregnant while enrolled in the study or within 3 months after the last
boost vaccination.
11. A history of bleeding or clotting disorders.
12. Any clinically significant acute or chronic medical condition* that, in
the opinion of the investigator, would preclude participation.
- E.g., history of seizure disorders, autoimmune disease,
immunodeficiency, any spleen disease, active malignancy, active
tuberculosis, asthma, or other systemic infections.
13. History of malignancy other than squamous cell or basal cell skin
cancer*, unless there has been surgical excision that is considered to
have achieved cure.
- Note: Subjects with a history of skin cancer must not be
vaccinated at the previous tumor site.
14. Prior organ and/or stem cell transplant.
15. Major surgery (per the investigator's judgment) within the 4 weeks
prior to study entry or planned major surgery through the course of the
study.
16. History of myocarditis, pericarditis, cardiomyopathy, transient
ischemic attack or stroke, myocardial infarction, angina, coronary
artery disease, congestive heart failure, or arrhythmia*.
*Note: This includes any clinically significant arrhythmia requiring
medication, treatment, or clinical follow-up.
17. Electrocardiogram (ECG) with clinically significant findings,* or
features that would interfere with the assessment of
myocarditis/pericarditis.
*Clinical significant findings include the following:
a. Conduction disturbance (complete left or complete right bundle branch block or
nonspecific intraventricular conduction disturbance with QRS > / = 120 ms, PR
interval > / = 210 ms, any second- or third-degree atrioventricular block, or
prolongation of the QT interval corrected according to Bazett's formula [QTcB] [>
450 ms]) b. Significant repolarization (ST-segment or T-wave) abnormality. c.
Significant atrial or ventricular arrhythmia; frequent atrial or ventricular
ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular
contractions in a row).
d. ST-elevation consistent with ischemia or evidence of past or evolving
myocardial infarction.
18. History of diabetes mellitus type 1 or type 2*, including cases controlled
with diet alone.
- Note: A history of isolated gestational diabetes is not an exclusion
criterion. 19. Thyroidectomy or thyroid disease requiring medication during
the last 12 months.
20. Uncontrolled hypertension, defined as systolic blood pressure > / = 140
mmHg or diastolic blood pressure > / = 90 mmHg.*
- Note: Vital signs must be normal by protocol toxicity grading scale or
determined to be normal-variant by investigator. In the event of an abnormal
heart rate or blood pressure due to physiological variation or activity, the
subject may rest for 10 minutes in a quiet room, and then blood pressure
and/or heart rate may be re-measured. Repeated vital signs may be used to
determine eligibility.
21. Received a licensed live vaccine within 30 days prior to enrollment in
this study, or plans to receive a licensed live vaccine within 30 days
before or after each study vaccine.
22. Received a licensed inactivated vaccine within 14 days prior to
enrollment in this study, or plans to receive a licensed inactivated vaccine
within 14 days before or after each study vaccine.
23. Use of experimental therapeutic agents within 3 months from the start of
screening.
24. Current or planned participation in another clinical study during the
study period.*
- Note: Participation in an observational clinical study is allowed. 25.
Receipt of blood products or immunoglobulin in the past 3 months. 26.
Donation of a unit of blood within 8 weeks before Day 1 or plans to donate
blood during participation in the study (from the start of screening
onwards).
27. Major psychiatric illness during the past 12 months that in the opinion
of the investigator would preclude participation.
28. Current or past abuse of recreational or narcotic drugs.*
- Note: Urine will be tested only at screening to check for use of
amphetamines, benzodiazepines, cocaine, and opioids.
29. Current or past alcohol use judged by the investigator to potentially
interfere with subject study adherence.
30. History of chronic urticaria (recurrent hives). 31. Chronic or recurrent
use of medications which modify host immune response (e.g., cancer
chemotherapeutic agents, parenteral corticosteroids).*
- Note: This is defined as greater than 2 weeks duration within three months
prior to vaccination or current use of immunosuppressive medication:
a. Permissible use during study include: corticosteroid nasal sprays for
allergic rhinitis and low dose inhaled corticosteroids defined as < 800
mcg/day of beclomethasone dipropionate CFC or equivalent.
b. Topical steroid for mild uncomplicated dermatitis such as poison ivy or
contact dermatitis should be completed before study.
c. Oral/parenteral corticosteroids given for non-chronic conditions not
expected to recur are permissible if the length of therapy was < / = 14 days
with completion at least 30 days prior to enrollment.
32. Subject who cannot communicate reliably with the investigator. 33.
Subject who, in the opinion of the investigator, is unlikely to adhere to
the requirements of the study.
34. Any condition that, in the opinion of the investigator, might interfere
with assessing the study objectives.
35. Personnel involved in the study*.
- Note: This includes the Principal Investigator (PI), sub-Investigators
listed in Form FDA 1572 or Investigator of Record Form, all staff who are
paid entirely or partially by/through the OCRR contract for the trial, and
staff who are supervised by the PI or sub-Investigators.
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