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A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
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).
Study details:
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of SK Japanese Encephalitis mRNA vaccines (GBP560) in healthy adults.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2025-02-20
Primary completion: 2026-06-26
Study completion finish: 2028-03-19
Study type
PREVENTION
Phase
PHASE1
PHASE2
Trial ID
NCT06680128
Intervention or treatment
BIOLOGICAL: GBP560-A
BIOLOGICAL: GBP560-B
BIOLOGICAL: IXIARO
BIOLOGICAL: IMOJEV
BIOLOGICAL: Normal Saline (Placebo)
Conditions
- • Japanese Encephalitis Virus Disease
Find a site
Closest Location:
Nucleus Network - Brisbane (Q Pharm)
Research sites nearby
Select from list below to view details:
Nucleus Network - Brisbane (Q Pharm)
Brisbane, Not Specified, Australia
Nucleus Network - Melbourne
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Test group 1-1 (GBP560-A)
| BIOLOGICAL: GBP560-A
|
EXPERIMENTAL: Test group 1-2 (GBP560-B)
| BIOLOGICAL: GBP560-B
|
EXPERIMENTAL: Test group1-3 (GBP560-A)
| BIOLOGICAL: GBP560-A
|
EXPERIMENTAL: Test group1-4 (GBP560-B)
| BIOLOGICAL: GBP560-B
|
EXPERIMENTAL: Test group1-5 (GBP560-A)
| BIOLOGICAL: GBP560-A
|
EXPERIMENTAL: Test group1-6 (GBP560-B)
| BIOLOGICAL: GBP560-B
|
ACTIVE_COMPARATOR: Control group1 (IXIARO®)
| BIOLOGICAL: IXIARO
|
ACTIVE_COMPARATOR: Control group2 (IMOJEV®)
| BIOLOGICAL: IMOJEV
|
EXPERIMENTAL: Test group 2-1 (GBP560-A or B)
| BIOLOGICAL: GBP560-A
|
EXPERIMENTAL: Test group 2-2 (GBP560-A or B)
| BIOLOGICAL: GBP560-A
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage of participants experiencing any immediate reactions | For all cohort | 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 | during the 7 days following each study vaccination |
Percentage of participants reporting any solicited systemic Adverse Event (AE) | For all cohort | during the 7 days following each study vaccination |
Percentage of participants experiencing any unsolicited Adverse Event (AE) | For all cohort | during the 28 days following each study vaccination |
Percentage of participants with any Medically Attended Adverse Event (MAAE) | For all cohort | 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 | 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 | 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. |
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 | 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 | 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 | 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 | 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. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | 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 | 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 | 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 | 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 | 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 | At baseline, 4 weeks following the 1st study vaccination, and at 4 weeks and 6 months following the 2nd study vaccination |
Frequently Asked Questions
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