A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
PHASE1PHASE2COMPLETED
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
- 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.
- 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).
- 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.
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
- 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).
- Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results.
- Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions).
- Female participants who are pregnant or breastfeeding.
- Current smoker or a recent smoking history within 12 weeks prior to screening (only for Stage 1).
- Receipt of JEV vaccination/other flaviviruses vaccination in the past.
- Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the last study vaccination (Visit 8), except for inactivated influenza vaccination.
- Receipt of immunoglobulins and/or any blood or blood-derived products within 12 weeks prior to the 1st study vaccination.
- Receipt of immunosuppressive therapy, such as any use of anti-cancer chemotherapy or radiation therapy; or systemic corticosteroid therapy (≥10 mg prednisone/day or equivalent) within 12 weeks prior to the 1st study vaccination.
- Participation in another clinical study and receipt of study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.
- Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
- Donation of ≥ 450mL (milliliter) of blood product within 4 weeks prior to screening, or planned donation of blood product from enrollment through 12 weeks after the last study vaccination (Visit 9).
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- PHASE1PHASE2
Study ID
NCT06680128
Intervention or treatment
BIOLOGICAL: GBP560-A
BIOLOGICAL: GBP560-B
BIOLOGICAL: IXIARO
BIOLOGICAL: IMOJEV
BIOLOGICAL: Normal Saline (Placebo)
Conditions
- Japanese Encephalitis Virus Disease
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Nucleus Network - Brisbane (Q Pharm)
Select from list below to view details:
Nucleus Network - Brisbane (Q Pharm)
Brisbane, Australia
Nucleus Network - Melbourne
Melbourne, Australia
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Who is running the clinical trial?
SBCL
SK Bioscience Co., Ltd.
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, Biological: Normal Saline (Placebo) |
EXPERIMENTAL: Test group 2-1 (GBP560-A or B)
| Biological: GBP560-A, Biological: GBP560-B |
EXPERIMENTAL: Test group 2-2 (GBP560-A or B)
| Biological: GBP560-A, Biological: GBP560-B |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 |
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References
Clinical Trials Gov: A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy AdultsOther trials to consider
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