MedTrace Logo

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

NCT06680128 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2025-12-23

No results posted yet for this study

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)

Conditions

  • Japanese Encephalitis Virus Disease

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)

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-06-26
Completion
2028-03-19

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680128 on ClinicalTrials.gov