drugset / Trial / NCT06680128

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

NCT06680128

Phase 1/2 Recruiting 402 enrolled SK Bioscience Co., Ltd.
RandomizedSequentialQuadruple-blindPrevention

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)

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject GBP560-A Messenger RNA (mRNA) 3 ug Intramuscular
Subject GBP560-A Messenger RNA (mRNA) 15 ug Intramuscular
Subject GBP560-A Messenger RNA (mRNA) 50 ug Intramuscular
Subject GBP560-B Messenger RNA (mRNA) 3 ug Intramuscular
Subject GBP560-B Messenger RNA (mRNA) 15 ug Intramuscular
Subject GBP560-B Messenger RNA (mRNA) 50 ug Intramuscular
Comparator IC51 Vaccine 6 unknown
Comparator IMOJEV Vaccine 4 unknown
Comparator IMOJEV Vaccine 5.8 unknown

Indications