Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Hand, Foot and Mouth Disease

Treatments: Biological: IN-B001 CVA16 B dose; Biological: IN-B001 EV71 A dose; Biological: Placebo; Biological: IN-B001 Bivalent C dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04637919

IN_HFM_102

Details and patient eligibility

About

This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

IN-B001 EV71 A dose

Experimental group

Description:

Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)

Treatment:

Biological: IN-B001 EV71 A dose

Biological: Placebo

IN-B001 CVA16 B dose

Experimental group

Description:

Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)

Treatment:

Biological: IN-B001 CVA16 B dose

Biological: Placebo

IN-B001 Bivalent C dose

Experimental group

Description:

Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)

Treatment:

Biological: Placebo

Biological: IN-B001 Bivalent C dose