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)
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of SK Japanese Encephalitis mRNA vaccines (GBP560) in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
402
injection volume of 0.5mililiter (mL) with each dose on V2(1day) and V5 (29day) in stage1 and stage2. Low dose: 3μg Mid dose: 15μg High dose: 50μg
injection volume of 0.5mL with each dose on V2(1day) and V5 (29day) in stage1 and stage2. Low dose: 3μg Mid dose: 15μg High dose: 50μg
injection volume of 0.5mL on V2(1day) and V5 (29day) in stage1 and stage2
Nucleus Network - Brisbane (Q Pharm)
Brisbane, Australia
RECRUITINGNucleus Network - Melbourne
Melbourne, Australia
RECRUITINGNew Zealand Clinical Research
Christchurch, Central City, New Zealand
NOT_YET_RECRUITINGPercentage of participants experiencing any immediate reactions
For all cohort
Time frame: 30 minutes (2 hours for the sentinel participants in stage 1) post each vaccination
Percentage of participants reporting any solicited local Adverse Event (AE)
For all cohort
Time frame: during the 7 days following each study vaccination
Percentage of participants reporting any solicited systemic Adverse Event (AE)
For all cohort
Time frame: during the 7 days following each study vaccination
Percentage of participants experiencing any unsolicited Adverse Event (AE)
For all cohort
Time frame: during the 28 days following each study vaccination
Percentage of participants with any Medically Attended Adverse Event (MAAE)
For all cohort
Time frame: until 6 months following the last study vaccination
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
For all cohort
Time frame: up to 12 months for stage 1 and up to 24 months for stage 2
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
For stage 2
Time frame: 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.
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injection volume of 0.5mL on V5 (29day) in stage1 and stage2
injection volume of 0.5mL on V2 (1day) in stage1 and stage2 (This is for IMOJEV placebo)
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
For Stage 2
Time frame: 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
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
For stage 2
Time frame: 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.
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
For Stage 2
Time frame: 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
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
For Stage 2
Time frame: 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.
Seroprotection 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 at each time point
For Stage 1
Time frame: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months following the 2nd study vaccination
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.
For stage 1
Time frame: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months following the 2nd study vaccination
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
For stage 1
Time frame: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months following the 2nd study vaccination
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 live-virus neutralization assay(PRNT), from each pre-vaccination to each subsequent timepoint
For stage 1
Time frame: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months following the 2nd study vaccination.
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
For Stage1
Time frame: At baseline, 2 weeks, 4 weeks following the 1st study vaccination, and at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months following the 2nd study vaccination.
Cell-mediated response for cytokines expressed by Cluster of Differentiation 4+ Cluster of Differentiation 8+ T cells (Interferon-γ, Tumor Necrosis Factor-α, measured by Fluorescence-Activated Cell Sorting-Intracellular Cytokine Staining assay.
For all cohort
Time frame: At baseline, 4 weeks following the 1st study vaccination, and at 4 weeks and 6 months following the 2nd study vaccination