A 2-Stage, Phase I/II, Active-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ \[Age\]

• 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.

• \[Type of Participant and Disease Characteristics\]

• 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

• \[Sex and Contraceptive/Barrier Requirements\]

• 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.

• \* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with amenorrhea for at least 12 months are not subject to a pregnancy test.

• \[Informed Consent\]

• 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.

Locations
Other Locations
Australia
Nucleus Network - Brisbane (Q Pharm)
RECRUITING
Brisbane
Nucleus Network - Melbourne
RECRUITING
Melbourne
New Zealand
New Zealand Clinical Research
NOT_YET_RECRUITING
Christchurch
Contact Information
Primary
Bora Kim
bora.kim@sk.com
82-2-2008-2200
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2028-03-19
Participants
Target number of participants: 402
Treatments
Experimental: Test group 1-1 (GBP560-A)
Low dose level(3µg) for GBP560-A in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Experimental: Test group 1-2 (GBP560-B)
Low dose level (3µg) for GBP560-B in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Experimental: Test group1-3 (GBP560-A)
Mid dose level (15µg) for GBP560-A in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Experimental: Test group1-4 (GBP560-B)
Mid dose level (15µg) for GBP560-B in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Experimental: Test group1-5 (GBP560-A)
High dose level (50µg) for GBP560-A in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Experimental: Test group1-6 (GBP560-B)
High dose level (50µg) for GBP560-B in stage 1. Participants will receive 2 doses of one of the test vaccines at 4-week intervals, respectively.
Active_comparator: Control group1 (IXIARO®)
Participants will receive 2 doses of one of the active comparators (IXIARO®, 6 Antigen Unit, corresponding to a potency of ≤ 460 ng ED) at 4-week intervals, respectively in Stage 1 and Stage 2.
Active_comparator: Control group2 (IMOJEV®)
Participants will receive 1 dose of placebo saline and 1 dose of another active comparator (IMOJEV®, 4.0 - 5.8 log PFU) at 4-week intervals, respectively in Stage 1 and Stage 2.
Experimental: Test group 2-1 (GBP560-A or B)
Participants will receive 2 intramuscular injections of the test vaccines in stage 2.~1st will be on Visit 2 and 2nd will be on Visit 5, in line with the selected dose regimen in stage 1.
Experimental: Test group 2-2 (GBP560-A or B)
Participants will receive 2 intramuscular injections of the test vaccines in stage 2.~1st will be on Visit 2 and 2nd will be on Visit 5, in line with the selected dose regimen in stage 1.
Related Therapeutic Areas
Sponsors
Leads: SK Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov

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