This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Inactivated vaccine against EV71, three doses, 28 days interval
Inactivated vaccine against EV71, three doses, 28 days interval
Inactivated vaccine against CVA16, three doses, 28 days interval
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
RECRUITINGFrequency and severity of adverse events of CJ-40010 (Safety of CJ-40010)
\- Frequency and severity of adverse events up to 32 weeks post first dose
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : Anti-EV71 IgG titer
Serum EV71-specific IgG titers
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Serum CVA16-specific IgG titers
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers
Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : GMT of CVA16 neutralizing antibody titers
Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against CVA16
Time frame: Week 0 to Week 32
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Inactivated vaccine against CVA16, three doses, 28 days interval
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo, three doses, 28 days interval