NCT06680128

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: SK Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Detailed description

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of SK Japanese Encephalitis mRNA vaccines (GBP560) in healthy adults.

Conditions

• Japanese Encephalitis Virus Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-06-26
• Completion: 2028-03-19
• First posted: 2024-11-08
• Last updated: 2025-12-23

Locations

3 sites across 2 countries: Australia, New Zealand