| Eligibility |
Inclusion Criteria:
- Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age
(inclusive) at the time of consent
- Volunteers must be able to provide written informed consent.
- Volunteers must be healthy as established by medical history and clinical examination
at study entry
- Volunteers must pass a comprehension test and be able to comply with all study
requirements.
- Female volunteers of non-childbearing potential (non-childbearing potential is defined
as having had one of the following: a tubal ligation at least 3 months prior to
enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).
- Female volunteers of childbearing potential may be enrolled in the study, if all the
following apply:
- Practiced adequate contraception for 30 days prior to challenge
- Has a negative urine pregnancy test on the day of DHIM
- Agrees to continue adequate contraception until two months after completion of the
DHIM
Exclusion Criteria:
- History of dengue infection or dengue illness, or history of flavivirus infection or
vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese
encephalitis, and dengue)
- Volunteers positive for antibodies to flaviviruses (FV) to include dengue virus, West
Nile virus, Yellow Fever virus, Zika virus, and Japanese encephalitis virus.
- Planned administration of any flavivirus vaccine for the entire study duration
- Any recent (within 4 weeks) or planned travel to any dengue endemic area while
participating in the trial
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required)
- Volunteer seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus
antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
- Safety laboratory test results at screening that are deemed clinically significant or
more than Grade 1 deviation from normal with the exception of PT/PTT, fibrinogen
decrease, ALT/AST increase (acceptable to 1.1 ULN), platelet decrease which will be
exclusionary at Grade 1 or higher
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests
- History of bipolar disorder, 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 volunteer from participating in the study
- Significant screening physical examination abnormalities at the discretion of the
investigator, including a BMI > 35 kg/m2
- Planned administration or administration of a vaccine/product not planned in the study
protocol during the period starting 30 days prior to the DHIM until 56 days after the
study completion (routine influenza or COVID-19 vaccination will be allowed if it is
not administered within 14 days preceding DHIM)
- Use of any investigational or non-registered product (drug or vaccine) other than the
study DHIM during the period starting 30 days preceding the DHIM and/or planned use
during the study period
- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs during the period starting 90 days prior to the DHIM
(for corticosteroids, this will mean prednisone 5 mg/day or equivalent; inhaled,
intranasal and topical steroids are allowed)
- Concurrently participating in another clinical study, at any time during the study
period, in which the volunteer has been or will be exposed to an investigational or a
noninvestigational product (pharmaceutical product or device)
- Autoimmune disease or history of autoimmune disease
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the study product or related to a study procedure
- Major congenital defects or serious chronic illness
- History of any neurological disorders or seizures
- Acute disease and/or fever (=37.5°C/99.5°F oral body temperature) at the time of
enrollment: note that a volunteer with a minor illness such as mild diarrhea, mild
upper respiratory infection, etc., without fever, may be enrolled at the discretion of
the investigator
- Administration of immunoglobulins and/or any blood products during the period starting
90 days preceding the DHIM or planned administration during the study period
- Recent history of chronic alcohol consumption (more than 2 drinks per day and/or drug
abuse) based on volunteer reported history
- Pregnant or breastfeeding female or female currently planning to become pregnant or
planning to discontinue adequate contraception
- Men who intend to father a child during the study period (approximately 2 months)
- Any religious or personal beliefs that bar the administration of blood products,
transfusions or serum albumin
- Planned or current administration of an HMG-CoA reductase inhibitor (i.e., lovastatin,
simvastatin, atorvastatin, etc.)
- Currently regularly taking anti-coagulant medication, aspirin, or non-steroidal
anti-inflammatory drugs (NSAIDs)
- Any other condition which, in the opinion of the investigator, prevents the volunteer
from participating in the study
- Temporary Exclusion Criteria:
- Acute disease and/or fever (> 38°C/100.4°F oral body temperature) at the time or
within 6 hours of challenge inoculation: note that a volunteer with a minor illness
such as mild upper respiratory infection, etc., without fever, and with a negative
SARS-CoV-2 upper respiratory (NP or nasal) swab PCR on the day of inoculation, may be
enrolled at the discretion of the investigator.
- Recent blood donation (within prior 56 days).
- Recent or scheduled receipt of any live vaccine 30 days and/or inactivated or sub-unit
vaccine 14 days prior to inoculation.
- Safety labs may be repeated once. If outside the 90-day screening window, the
volunteer may be rescreened except for flavivirus, hepatitis, and HIV viral screens.
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