A 2-Stage, Phase I/II, Active-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)
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)
⁃ \[Age\]
• For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• For Stage 2, participant must be 18 years of age and older, at the time of signing the informed consent.
• \[Type of Participant and Disease Characteristics\]
• 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
• \[Sex and Contraceptive/Barrier Requirements\]
• All participants must agree to be heterosexually inactive or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination (Visit 9) (See Appendix 10.4 for detailed contraceptive methods).
• Female participants with a negative urine or serum pregnancy test at screening.
• \* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with amenorrhea for at least 12 months are not subject to a pregnancy test.
• \[Informed Consent\]
• Participants who are capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol before initiation of any trial-specific procedures.