NCT04182932

Safety and Immunogenicity of CJ-40010 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of CJ-40010 After Administration in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects

Detailed description

Enterovirus 71(EV71) and coxsackievirus A16(CVA16) are major causes of Hand-foot-and-mouth disease (HFMD) occurring in pediatric population. Although EV71 vaccine has been licensed in China, vaccine for CVA16-associated HFMD is currently not available anywhere. The purpose of this phase I study is to evaluate the safety and immunogenicity of EV71/CVA16 bivalent vaccine in healthy adults.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	CJ-40010 EV71 vaccine A dose	Inactivated vaccine against EV71, three doses, 28 days interval
BIOLOGICAL	CJ-40010 EV71 vaccine B dose	Inactivated vaccine against EV71, three doses, 28 days interval
BIOLOGICAL	CJ-40010 CVA16 vaccine C dose	Inactivated vaccine against CVA16, three doses, 28 days interval
BIOLOGICAL	CJ-40010 CVA16 vaccine D dose	Inactivated vaccine against CVA16, three doses, 28 days interval
BIOLOGICAL	CJ-40010 Bivalent vaccine E dose	Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
BIOLOGICAL	CJ-40010 Bivalent vaccine high dose	Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
BIOLOGICAL	Placebo	Placebo, three doses, 28 days interval

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2019-12-02
• Last updated: 2019-12-03

Locations

1 site across 1 country: South Korea