Eligibility Details:
Inclusion Criteria:
1. Provide written informed consent before initiation of any study procedures.
2. Are able to understand and comply with planned study procedures and be available for
all study visits/phone calls.
3. Males or non-pregnant females ages 18-45, inclusive.
4. Subject must have a body mass index (BMI) > / = 18.5 and < 35 kg/m^2.
5. Are in good health.
- As determined by medical history and physical examination to evaluate acute or
currently ongoing chronic medical diagnoses or conditions, defined as those that
have been present for at least 90 days which would affect the assessment of the
safety of subjects or the immunogenicity of study vaccinations. Chronic medical
diagnoses or conditions should be stable for the last 60 days (no
hospitalizations, ER or urgent care for condition and no adverse symptoms that
need medical intervention such as medication change/supplemental oxygen). This
includes no change in chronic prescription medication, dose, or frequency as a
result of deterioration of the chronic medical diagnosis or condition in the 60
days prior to enrollment. Any prescription change that is due to change of health
care provider, insurance company, etc., or that is done for financial reasons, as
long as in the same class of medication, will not be considered a deviation of
this inclusion criterion. Any change in prescription medication due to
improvement of a disease outcome, as determined by the site principal
investigator or appropriate sub-investigator, will not be considered a deviation
of this inclusion criterion. Subjects may be on chronic or as needed (prn)
medications if, in the opinion of the site principal investigator or appropriate
sub-investigator, they pose no additional risk to subject safety or assessment of
reactogenicity and immunogenicity and do not indicate a worsening of medical
diagnosis or condition. Similarly, medication changes subsequent to enrollment
and study vaccination are acceptable provided there was no deterioration in the
subject's chronic medical condition that necessitated a medication change, and
there is no additional risk to the subject or interference with the evaluation of
responses to study vaccination. Note: Topical, nasal, and inhaled medications
(apart from steroids as outlined in the Subject Exclusion Criteria), herbals,
vitamins, and supplements are permitted.
6. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
7. Pulse is 47 to 105 beats per minute (bpm), inclusive.
8. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
9. Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
10. Have acceptable screening laboratories within 28 days prior to enrollment
- Screening labs include white blood cell (WBC), Hgb, platelet count, ANC, sodium,
potassium, creatinine, albumin, total protein, PT, PTT, alanine aminotransferase
(ALT). Blood Urea Nitrogen (BUN) will be obtained only if creatinine is above
normal range.
- Screening laboratory values that are outside the range of eligibility but
are thought to be due to an acute condition or due to laboratory error may
be repeated once.
11. Have normal screening laboratories for urine protein. Trace protein is acceptable.
12. Drug screen for opiates is negative.
13. Hemoglobin A1C (HgbA1C) < 6.3% at screening.
14. HIV 1/2 antibody negative.
15. HCV antibody negative.
16. HBsAg negative.
17. Women of childbearing potential, must be using an effective method of contraception
from 30 days prior to the first study vaccination until 90 days after the second study
vaccination.
- Women of childbearing potential are not sterilized via tubal ligation, bilateral
oophorectomy, hysterectomy, successful Essure(R) placement (permanent, non-surgical,
non-hormonal sterilization) with history of documented radiological confirmation test
at least 90 days after the procedure (or with use of another birth control method if
history of confirmation test not confirmed), still menstruating, or < 1 year of the
last menses if menopausal.
-- Effective methods of contraception includes, but is not limited to, non-male sexual
relationships, abstinence from sexual intercourse with a male partner, monogamous
relationship with a vasectomized partner, male condoms with the use of applied
spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as
implants, injectables or oral contraceptives ("the pill").
18. Women of childbearing potential must have a negative serum pregnancy test at screening
and a negative urine pregnancy test within 24 hours prior to each study vaccination.
19. Women agree to not donate eggs (ova, oocytes) from the start of screening onwards
until at least 90 days after the second vaccination.
20. Agrees not to participate in another clinical trial during the study period.
21. Agrees not to donate blood to a blood bank for 3 months after receiving the second
study vaccine.
Exclusion Criteria:
1. Women who are pregnant, planning to become pregnant or lactating. - Includes
breastfeeding or planning to breastfeed at any given time from the receipt of study
vaccination through the 6-month trial period.
2. Known allergy or history of anaphylaxis, severe local or other serious adverse
reactions to vaccines or vaccine products, or history of severe allergic reactions.
- 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)).
3. Received an experimental agent within 3 months prior to Day 1, or expects to receive
an experimental agent (other than from participation in this study) during the 6-month
trial-reporting period.
- Including vaccine, drug, biologic, device, blood product, or medication.
4. Received immunoglobulin or other blood product within 3 months before enrollment in
this study.
5. Received any licensed live vaccine within 30 days prior to the first study vaccination
through 30 days after the second study vaccination.
6. Received a licensed inactivated vaccine within 14 days prior to the first study
vaccination through 14 days after the second study vaccination.
7. Has been vaccinated with an Ebola vaccine.
8. Has been diagnosed with Ebola disease, or exposed to Ebola virus including travel to
West Africa in 2014-2016.
- West Africa includes but is not limited to the countries of Guinea, Liberia, Mali,
Nigeria, and Sierra Leone.
9. Known or suspected receipt of ChAd3-EBO-Z or other ChAd3-vectored vaccine.
10. Known or suspected receipt of an adenovirus serotype 5 (Ad5)-based vaccine.
11. Known or suspected receipt of any licensed or investigational small pox
(vaccinia)-based vaccine.
- Includes any MVA-based candidate vaccine (Imvamune or Imvanex), Dryvax, or Acam2000.
12. Has a typical vaccinia scar.
13. Confirmed Asplenia/Functional Asplenia.
14. A history of bleeding or clotting disorders.
15. Thyroidectomy or thyroid disease requiring medication during the last 12 months.
16. History of chronic urticaria (recurrent hives).
17. Individuals in whom the ability to observe possible local reactions at the eligible
injection sites (left and right deltoid region) is, unacceptably obscured due to a
physical condition or permanent body art.
18. Have an acute illness, as determined by the site PI or appropriate sub-investigator,
within 72 hours prior to study vaccination.
- An acute illness which is nearly resolved with only minor residual symptoms
remaining is allowable if, in the opinion of the site PI or appropriate
sub-investigator, the residual symptoms will not interfere with the ability to assess
safety parameters as required by the protocol. Subjects may re-screen after an acute
illness is resolved.
19. Any confirmed or suspected immunosuppressive or immunodeficient condition (including
HIV infection) or use of anticancer chemotherapy or radiation therapy (cytotoxic)
within 3 years prior to study vaccination
20. Administration of chronic (defined as more than 14 days) immunosuppressants or other
immune modifying drugs within 6 months of receipt of study vaccine.
21. Have taken oral or parenteral (including intraarticular) corticosteroids of any dose
within 30 days prior to study vaccination.
22. Have taken high-dose dose inhaled corticosteroids within 30 days prior to study
vaccination.
- High-dose defined using the inhaled high-dose reference chart.
23. Have a history of convulsions or encephalomyelitis within 90 days prior to study
vaccination.
24. Current or past history of alcohol or drug abuse in the last 5 years.
25. Subjects with autoimmune disorders, chronic inflammatory disorders or neurological
disorders with a potential autoimmune correlation.
26. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other
psychiatric diagnosis that may interfere with subject compliance or safety
evaluations.
27. Have been hospitalized for psychiatric illness, history of suicide attempt, or
confinement for danger to self or others within 10 years prior to study vaccination.
28. Have received any antiviral within 3 days of study vaccination
29. History of myocarditis, pericarditis, cardiomyopathy, transient ischemic attack or
stroke, myocardial infarction, angina, coronary artery disease, congestive heart
failure, clinically significant arrhythmia.
- Including any arrhythmia requiring medication, treatment, or clinical follow-up.
30. Electrocardiogram (ECG) with clinically significant findings.
- Clinically significant findings include the following:
- 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]).
- Significant repolarization (ST-segment or T-wave) abnormality.
- Significant atrial or ventricular arrhythmia; frequent atrial or ventricular
ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular
contractions in a row).
- ST-elevation consistent with ischemia or evidence of past or evolving myocardial
infarction
31. A diagnosis of Type I or II diabetes. (A history of isolated gestational diabetes is
not an exclusion criterion).
32. Current employee or staff paid entirely or partially by the contract for this trial,
or staff who are supervised by the PI or Sub-Investigators.
33. Any condition that would, in the opinion of the Site Investigator or appropriate
sub-investigator, is a contraindication to study participation.
- Including acute or chronic (persisting for at least 90 days) clinically
significant medical disease or condition, that would place the subject at an
unacceptable risk of injury, render the subject unable to meet the requirements
of the protocol, or may interfere with the evaluation of responses or the
subject's successful completion of the study.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
