This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 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.

Inclusion Criteria:

• Healthy adult aged ≥19 to <50 years at the time of screening tests
• Body mass index(BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2, with body weight of ≥55.0 kg to ≤90.0 kg for men and ≥50.0 kg to ≤90.0 kg for women at the time of screening tests
• Determined by the investigator to be eligible for study participation based on the results of screening tests
• Intact deltoid muscle that allows administration of the investigational product
• Consent to use medically acceptable contraception throughout the study
• Negative finding from a pregnancy test (urine hCG) at the time of the screening for women of childbearing potential
• Voluntary decision and provision of written consent on participation in this study

Exclusion Criteria:

• History of a hand-foot-mouth disease or history of a disease related with enterovirus(EV) infection within 3 months prior to the 1st IP administration
• Medical history of an anaphylactic or similar acute reaction to IN-B001 or similar vaccine
• Febrile disease or infectious disease within 2 weeks prior to the 1st IP administration
• Whole blood donation within 2 months or apheresis within 1 month prior to the 1st IP administration
• Vaccination with other prevention vaccine within 2 months prior to the 1st IP administration
• Use of an immunomodulator or immunosuppressant within 3 months prior to the 1st IP administration
• History of a Guillain Barre syndrome
• Excessive caffeine intake or continuous alcohol consumption or incapable of abstention from alcohol during the study
• Participation in other clinical trial within 6 months prior to the 1st IP administration
• Pregnant or breastfeeding women
• Clinically significant hepatic, renal, neurological, respiratory, endocrine, hematology and oncology, cardiovascular, urological or psychiatric disease or such history
• Positive serological finding (type B hepatitis test, type C hepatitis test, human immunodeficiency virus(HIV) test)
• History of drug abuse or positive finding from a urine screening test for an abusive drug
• Use or of any prescription medication or oriental medicine within 2 weeks or any over-the-counter(OTC) medication, health functional food or vitamin within 1 week prior to the 1st IP administration or expected use of such products
• Administration of a blood product or blood-derived agent within 3 months prior to the 1st IP administration
• Determined by the investigator to be ineligible for study participation due to other reason including clinical laboratory findings