Actively Recruiting
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
Led by SK Bioscience Co., Ltd. · Updated on 2025-12-23
402
Participants Needed
3
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 55 years for Stage 1, or 18 years and older for Stage 2
- Healthy adults based on medical history, exam, vital signs, and lab tests
- Willing and able to attend all study visits and follow procedures
- Body mass index between 18.5 and 29.9 kg/m2 at screening
- Agree to be heterosexually inactive or use effective contraception from 4 weeks before first vaccination until 12 weeks after last vaccination
- Female participants must have a negative pregnancy test at screening unless surgically sterile or postmenopausal
- Able to give signed informed consent
You will not qualify if you...
- Respiratory symptoms, fever over 38°C, or acute illness within 24 hours before first vaccination
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease
- Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test at screening
- History of bleeding disorder or thrombocytopenia contraindicating intramuscular vaccination
- History of severe allergic reactions to vaccines or vaccine components
- History of myocarditis, pericarditis, or myopericarditis or abnormal ECG affecting safety
- History of Japanese Encephalitis or other flavivirus infections
- History of malignancy within 1 year before first vaccination (except low risk cases)
- Significant unstable chronic or acute illness posing health risk or interfering with study
- Other conditions affecting study evaluation like alcohol/drug abuse or neurological/psychiatric disorders
- Pregnant or breastfeeding females
- Current smoker or recent smoking within 12 weeks before screening for Stage 1
- Previous Japanese Encephalitis or other flavivirus vaccination
- Vaccination within 4 weeks before first vaccination or planned vaccination until 4 weeks after last vaccination except inactivated flu vaccine
- Immunoglobulin or blood product receipt within 12 weeks before first vaccination
- Immunosuppressive therapy including chemotherapy, radiation, or systemic corticosteroids within 12 weeks before first vaccination
- Participation in another clinical study with intervention within 4 weeks before or during this study
- Investigators, study staff, or their family members involved in this study
- Blood donation of 450 mL or more within 4 weeks before screening or planned donation until 12 weeks after last vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Nucleus Network - Brisbane (Q Pharm)
Brisbane, Australia
Actively Recruiting
2
Nucleus Network - Melbourne
Melbourne, Australia
Actively Recruiting
3
New Zealand Clinical Research
Christchurch, Central City, New Zealand, 8011
Not Yet Recruiting
Research Team
S
Sejun Oh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
10
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