This is a 2-Stage, Phase I/II Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)
For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests and medical judgement of the investigator.
Participants who are willing and able to attend all scheduled visits and comply with all study procedures.
Body mass index (BMI) within the range of 18.5-29.9 kg/m2 (inclusive) at screening
Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution.
History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.
History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion.
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Treatment groupsSee each treatment group below.