A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Mess… (NCT06680128) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
Australia, New Zealand402 participantsStarted 2025-02-24
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Percentage of participants experiencing any immediate reactions
Timeframe: 30 minutes (2 hours for the sentinel participants in stage 1) post each vaccination
2
Percentage of participants reporting any solicited local Adverse Event (AE)
Timeframe: during the 7 days following each study vaccination
3
Percentage of participants reporting any solicited systemic Adverse Event (AE)
Timeframe: during the 7 days following each study vaccination
4
Percentage of participants experiencing any unsolicited Adverse Event (AE)
Timeframe: during the 28 days following each study vaccination
5
Percentage of participants with any Medically Attended Adverse Event (MAAE)
Timeframe: until 6 months following the last study vaccination
6
Percentage of participants experiencing any Adverse Event of Special Interest (AESI)s, AEs leading to study withdrawal and Serious Adverse Event (SAE)s during the entire study period
Timeframe: up to 12 months for stage 1 and up to 24 months for stage 2
7
Seroprotection rate for both the respective and cross Japanese encephalitis virus (JEV) strains of each vaccine (SA14-14-2 and Beijing-1 strain) in live-virus neutralizing antibody titers at each time point
✕. 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.
✕. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study intervention.
✕. History of myocarditis, pericarditis or myopericarditis (including the screening 12-lead ECG results from Stage 1 participants), as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant abnormalities that could affect participant safety or the interpretation of study findings.
✕. History of JEV infection/other flaviviruses infection (e.g., Dengue, West Nile, Zika, St. Louis Encephalitis, Yellow fever).
✕. History of malignancy within 1 year prior to the 1st study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator).
Timeframe: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months following the 2nd study vaccination.
8
Seroresponse rate for both the respective and cross JEV strains of each vaccine (SA14-14-2 and Beijing-1 strain) in live-virus neutralizing antibody titers, from baseline to each subsequent time point
Timeframe: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months following the 2nd study vaccination
9
Geometric Mean Titer (GMT) of neutralizing antibody against both the respective and cross JEV strains of each vaccine (SA14-14-2 and Beijing-1 strain) measured by a live-virus neutralization assay (PRNT) at each time point
Timeframe: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months following the 2nd study vaccination.
10
Geometric mean fold rise of neutralizing antibody against both the respective and cross JEV strains of each vaccine (SA14-14-2,Beijing-1 strain), measured by a live-virus neutralization assay(PRNT), from each pre-vaccination to each subsequent timepoint
Timeframe: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months following the 2nd study vaccination
11
Geometric mean fold reduction of neutralizing antibody against both respective and cross JEV strains of each vaccine (SA-14-14-2,Beijing-1 strain), measured by live-virus neutralization assay (PRNT) from persistence baseline to each subsequent timepoint
Timeframe: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months following the 2nd study vaccination.