| Eligibility |
Inclusion Criteria:
- Male or female between 18 and 42 years of age (inclusive) at the time of consent
- Able to provide written informed consent
- Healthy as established by medical history and clinical examination and basic
hematologic laboratory analysis before entering into the study
- Able and willing to comply with the requirements of the protocol (eg, document events
in memory aid, return for follow-up visits, etc.)
- Dengue exposure naïve as established by pre-enrollment dengue PRNT testing and
questioning of volunteer
- Female subject of non-childbearing potential (non-childbearing potential is defined as
having either a current bilateral tubal ligation at least 3 months prior to enrollment
or a history of an hysterectomy, bilateral oophorectomy, or is post-menopause(12
months or more since last menstrual period)) or Female subject of childbearing
potential may be enrolled in the study, if the subject has:
- Practiced adequate contraception for 30 days prior to vaccinations, and
- A negative urine pregnancy test on each day of vaccination, and
- Agreed to continue adequate contraception through at least 3 months following
last vaccination
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine or device) other
than the study vaccines during the period starting 30 days preceding the first dose of
study vaccine and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of prescription
immunosuppressants or other prescription immune-modifying drugs during the period
starting 180 days prior to the first vaccine dose
- For corticosteroids, this will mean prednisone = 20 mg/d or equivalent
- Inhaled and topical steroids are allowed
- History of or active use of cancer chemotherapy or radiation therapy for the treatment
of cancer
- Receipt or planned receipt of a vaccine/product outside the study protocol within 30
days of each scheduled dose of an investigational product
- Planned administration of any flavivirus vaccine, to include licensed vaccines for
Yellow Fever or Japanese Encephalitis Virus as well as other investigational vaccines
for dengue, Zika, West Nile, other flavivirus, for the entire study duration
- Previous receipt of a foreign or investigational dengue vaccine
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination
- History of, or current, auto-immune disease
- History of any reaction or hypersensitivity likely to be triggered by any component of
the vaccines or related to a study procedure (This includes hypersensitivity reactions
to alum, streptomycin, neomycin, or any other flavivirus vaccine, such as Yellow Fever
virus and Japanese Encephalitis virus vaccines)
- Major congenital defects or serious chronic illness
- History of any chronic neurological disorders or chronic and/or uncontrolled seizures
- Acute infectious disease and/or fever (oral body temperature = 100.4°F/38.0°C) at the
time of enrollment (a subject with a minor illness, ie, mild diarrhea, mild upper
respiratory infection, etc., without fever, may be enrolled at the discretion of the
investigator)
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
functional abnormality, as determined by history, physical examination or laboratory
screening tests
- Receipt of immunoglobulins or any blood products during the period starting 90 days
preceding the first dose of study vaccine or planned receipt during the study period
- Donated blood within 8 weeks before first scheduled investigational vaccine receipt or
planned donation of blood products throughout the study period
- History of chronic alcohol abuse and/or drug abuse that, in the opinion of the
investigator, could result in poor compliance with study requirements.
- Pregnant or breastfeeding female or female planning to become pregnant or planning to
discontinue contraceptive precautions
- A planned move to a location that will prohibit compliance with the requirements of
the trial
- Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus
antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
- Safety laboratory test results that are outside the acceptable values at screening:
- > 110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate
aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen
(SUN) and bilirubin (total and direct)
- < 100% lower limit of normal (LLN) or > 120% ULN for hemoglobin, hematocrit and
platelet count
- < 75% LLN or >110% ULN for total white blood cell count (WBC) Note: Per guidance
in section 8.1, abnormal lab(s) may be repeated x1 in the screening window
provided the total amount of blood drawn for all screening labs does not exceed
50 mL.
- Active Diabetes or active peptic ulcer disease (PUD)
- Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for
a mental health disorder, or any other psychiatric condition, which in the opinion of
the investigator prevents the subject from meeting all requirements of the study
- Chronic migraine headaches, defined as more than 15 headache days per month over a 3
month period of which more than 8 are migrainous, in the absence of medication over
use
- Chronic medical condition that, in the opinion of the investigator, impacts subject
safety
- Any other condition which, in the opinion of the investigator, prevents the subject
from meeting all requirements of the study.
- Do not wish to have their blood stored and used for future research
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