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RECRUITING
NCT06680128
PHASE1/PHASE2

A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults

Sponsor: SK Bioscience Co., Ltd.

View on ClinicalTrials.gov

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)

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

402

Start Date

2025-02-24

Completion Date

2028-03-19

Last Updated

2025-12-23

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

GBP560-A

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

BIOLOGICAL

GBP560-B

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

BIOLOGICAL

IXIARO

injection volume of 0.5mL on V2(1day) and V5 (29day) in stage1 and stage2

BIOLOGICAL

IMOJEV

injection volume of 0.5mL on V5 (29day) in stage1 and stage2

BIOLOGICAL

Normal Saline (Placebo)

injection volume of 0.5mL on V2 (1day) in stage1 and stage2 (This is for IMOJEV placebo)

Locations (3)

Nucleus Network - Brisbane (Q Pharm)

Brisbane, Australia

Nucleus Network - Melbourne

Melbourne, Australia

New Zealand Clinical Research

Christchurch, Central City, New Zealand