Eligibility Details:
Inclusion Criteria:
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 49 years of age
- In the opinion of the investigator, can and will comply with the requirements of the
protocol (e.g., complete diary cards, return for follow-up visits, be available for
safety telephone calls).
- Is in good general health, as determined by medical history, clinical laboratory
assessments, vital sign measurements, and physical examination at screening.
- Negative urine pregnancy test at the Screening visit and at the day of each
vaccination for females of childbearing potential.
- Male participants must agree to practice adequate contraception from the time of the
first vaccination and through 3 months following the last vaccination.
- For flavivirus-seropositive group, has positive flavivirus test results (including
dengue, West Nile, and Zika) as determined by ELISA or other commercially available
serological assay.
- For flavivirus-seronegative group, has negative flavivirus test results (including
dengue, West Nile, and Zika) as determined by ELISA or other commercially available
serological assay.
Exclusion Criteria:
- Has any acute or chronic, Clinically Significant disease in the opinion of the
investigator.
- Has received a vaccine for dengue, Japanese encephalitis, tick-borne encephalitis,
West Nile, Yellow Fever, or Zika.
- Has a neurologic disorder
- Has a body mass index that is ≤ 18 or ≥ 35 kg/m2.
- Has elevated liver function tests
- Has clinical laboratory test results (hematology, serum chemistry, or coagulation)
with a toxicity score of Grade ≥ 1 at Screening.
- Has a bleeding disorder that would contraindicate IM injections or phlebotomy.
- Reports a diagnosis of congenital or acquired immunodeficiency (including HIV
infection), or autoimmune disease.
- Has a history of hypersensitivity or severe reactions to previous vaccinations or any
component of the study vaccine.
- Has a history of idiopathic urticaria.
- Reports a previous diagnosis of hematologic malignancy or pre-malignancy or a
diagnosis of any other malignancy within the previous 10 years (excluding nonmelanoma
skin cancer).
- Has a medical, psychiatric, or occupational condition that, in the opinion of the
investigator, might pose an additional risk to the participant due to participation in
the study or would interfere with the evaluation of the study vaccines or the
interpretation of study results.
- Is acutely ill or febrile on the day of screening (Day 0) or randomization (Day 1).
- Has a history of inflammatory arthritis.
- Has a history of febrile disease with arthritis or arthralgia within 2 weeks of
administration of any study vaccine.
- Has received an investigational or nonregistered product (drug or vaccine) within 30
days before the first dose of study vaccine or has plans for administration during the
study period.
- Has received or is scheduled to receive an inactivated vaccine within the period from
14 days before, or through 14 days after, administration of any study vaccination.
- Has received or is scheduled to receive a live virus vaccine administered within the
period from 28 days before, or through 28 days after, any dose of study vaccine.
- Has received chronic administration (defined as > 14 total days) of immunosuppressants
or other immune-modifying drugs within 6 months before the first study vaccine dose.
- Has received immunoglobulins and/or blood products within the 3 months before the
first study vaccine dose or has plans for administration during the study period.
- Has a positive test result at the Screening Visit for hepatitis B surface antigen,
hepatitis C virus antibody, or HIV type 1 or 2 antibodies.
- Has donated > 450 mL of whole blood or blood products within 30 days of enrollment or
plans to do so during the study period.
- Is an immediate family member or household member of study personnel.
- Previously participated in an investigational study involving LNPs.
- Has a positive urine drug screen result at Screening for any of the following
nonprescription drugs of abuse: amphetamines, benzodiazepines, cocaine, methadone,
opiates, and phencyclidine.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
