| Eligibility |
Inclusion Criteria:
1. Provide written informed consent prior to initiation of any study procedures.
2. Are able to understand and comply with planned study procedures and be available for
all study visits.
3. Must agree to the collection of venous blood per protocol.
4. Are males or non-pregnant females, =18 and <50 years of age, inclusive at time of
enrollment.
5. Are in good health*. *As determined by medical history and physical examination to
evaluate acute or currently ongoing chronic medical or psychiatric 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, emergency room or urgent care for condition, or invasive
medical procedure and no adverse symptoms that need medical intervention such as
medication change/supplemental oxygen). This includes no change in chronic
prescription medication, dose or 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. Subjects may be on chronic or as
needed (prn) medications if, in the opinion of the site PI or appropriate
sub-investigator, they pose no additional risk to subject safety or assessment of
reactogenicity and immunogenicity and do not indicate a worsening or treatment of
continued symptoms of medical diagnosis or condition. Note: Low dose topical,
corticosteroids as outlined in the Subject Exclusion Criteria (see below) as well as
herbals, vitamins and supplements are permitted.
6. Oral temperature is less than 100.0°F.
7. Pulse is 47 to 100 beats per minute, inclusive.
8. Systolic blood pressure is 85 to 140 mmHg, inclusive.
9. Diastolic blood pressure is 55 to 90 mmHg, inclusive.
10. Screening laboratories (WBC, Hgb, PLTs, Sodium, Potassium, Bicarbonate, Calcium, Cr,
non-fasting glucose, ALT, AST, TBIL and urine protein and glucose) are within
acceptable parameters*. *Hematology, blood chemistry and liver enzymes must be Grade 1
or less at screening; urine glucose and protein negative at screening for subjects to
qualify for randomization and vaccination.
11. Negative test for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) at
screening blood draw.
12. Women of childbearing potential* must use an acceptable contraception method† from at
least 30 days before the first study vaccination until 30 days after the second study
vaccination. *Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy,
or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization)
with documented radiological confirmation test at least 90 days after the procedure,
and still menstruating or <1 year has passed since the last menses if menopausal.
†Includes non-male sexual relationships, full abstinence from sexual intercourse with
a male partner, monogamous relationship with vasectomized partner who has been
vasectomized for 180 days or more and shown to be azoospermic prior to the subject
receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal
ligation, and licensed hormonal methods such as implants, injectables or oral
contraceptives (i.e. "the pill").
13. 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.
14. Sexually active males must agree to use a medically acceptable form of contraception*
in order to be in this study and must agree to continue such use until day 30 after
the last vaccination. *Medically acceptable contraceptives include: (1) surgical
sterilization (such as a vasectomy), or (2) a condom used with a spermicide.
Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex,
are not acceptable methods for routine use.
Exclusion Criteria:
1. Have an acute illness* or acute febrile illness (oral temperature = 38C [100.4F]), 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.
2. Have any medical disease or condition that, in the opinion of the site PI or
appropriate sub-investigator, is a contraindication to study participation*.
*Including acute, subacute, intermittent or chronic 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 this trial.
3. Have immunosuppression as a result of an underlying illness or treatment, a recent
history or current use of immunosuppressive or immunomodulating disease therapy.
4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior
to study vaccination.
5. Have known active or recently active (12 months) neoplastic disease or a history of
any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
6. Known allergy to components of the study product*. *Including the following: aluminum
hydroxide, sorbitol, potassium chloride, sodium chloride and polysorbate80 (Tween80)
7. Unstable seizure disorder (defined as requiring medication for seizure control or with
seizure activity within the past 3 years).
8. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
9. Have any diagnosis, current or past, of schizophrenia, bipolar disease or other
psychiatric diagnosis that may interfere* with subject compliance or safety
evaluations. *As determined by the site PI or appropriate sub-investigator.
10. Have been hospitalized for psychiatric illness, history of suicide attempt, or
confinement for danger to self or others within 5 years prior to study vaccination.
11. Have a history of asthma, other than mild, well-controlled asthma*. *Cold or exercise
induced asthma controlled with inhaled medications other than inhaled corticosteroids
is permissible. Participants should be excluded if they require daily bronchodilator
use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have
used theophylline or inhaled corticosteroids in the past year.
12. Have a history of diabetes mellitus.
13. Have taken oral or parenteral (including intra-articular) or chronic topical
corticosteroids of any dose within 30 days prior to study vaccination*.
*Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a
topical corticosteroid for a limited duration for mild uncomplicated dermatitis such
as poison ivy or contact dermatitis may be enrolled the day after their therapy is
completed.
14. Have taken high-dose inhaled corticosteroids* within 30 days prior to study
vaccination. *High-dose defined as per age as using inhaled high-dose per reference
chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and
Management of Asthma (EPR-3) or other lists published in UPTODATE.
15. Received or plan to receive a licensed, live vaccine within 30 days before or after
each study vaccination.
16. Received or plan to receive a licensed, inactivated vaccine or allergy desensitization
shot within 14 days before or after each study vaccination.
17. Received an experimental agent* within 30 days prior to the study vaccination or
expect to receive another experimental agent† during the trial-reporting period‡.
*Including vaccine, drug, biologic, device, blood product, or medication. †Other than
from participation in this trial. ‡Approximately 7 months after the first study
vaccination.
18. Are participating or plan to participate in another clinical trial with an
interventional agent* that will be received during the trial-reporting period†.
*Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or
medication. †Approximately 7 months after the first study vaccination.
19. Female subjects who are breastfeeding or plan to breastfeed from the time of the first
study vaccination through 30 days after the last study vaccination.
20. Receipt of blood products or immunoglobulin within six months prior to enrollment.
21. Donation of a unit of blood within 60 days prior to enrollment or intends to donate
blood during the study period.
22. Body mass index (BMI) = 35.
23. History of a visit to South America, sub-Saharan Africa or Southeast Asia lasting one
month or more.
24. Planned travel to areas known to be endemic with Yellow Fever virus during the study
period.
25. History of military service.
26. History of vaccination against dengue, yellow fever, tick-borne encephalitis, or
Japanese encephalitis.
27. History of vaccination with other flavivirus candidate vaccines.
28. Attended primary (grade) school in Austria, Germany, Japan, South Korea, India,
Thailand, Nepal, Vietnam, or Taiwan (locations where the tick-borne encephalitis
vaccine is given).
29. History of yellow fever.
30. Plan to have a major change in exercise routine or perform strenuous exercise from 72
hours before any dose of study vaccine/placebo and for 72 hours before any safety
laboratories*. *Safety laboratories are obtained on Days 4 and 15 following each dose
of study product.
31. Contraindication to intramuscular vaccination of either upper arm (for example, due to
lymphadenectomy or obscuring tattoos).
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