Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects
Phase 1
- Conditions
- Hand, Foot and Mouth Disease
- Interventions
- Biological: IN-B001 Bivalent C doseBiological: IN-B001 EV71 A doseBiological: IN-B001 CVA16 B doseBiological: Placebo
- Registration Number
- NCT04637919
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IN-B001 CVA16 B dose Placebo Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) IN-B001 Bivalent C dose Placebo Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) IN-B001 Bivalent C dose IN-B001 Bivalent C dose Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) IN-B001 EV71 A dose IN-B001 EV71 A dose Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) IN-B001 EV71 A dose Placebo Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) IN-B001 CVA16 B dose IN-B001 CVA16 B dose Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
- Primary Outcome Measures
Name Time Method Frequency and severity of adverse events of IN-B001 (Safety of IN-B001) Week 0 to Week 32 Frequency and severity of adverse events up to 32 weeks post first dose
- Secondary Outcome Measures
Name Time Method Immunogenicity of IN-B001: Anti-EV71 IgG titer Week 0 to Week 32 Serum EV71-specific IgG titers
Immunogenicity of IN-B001 : Anti-CVA16 IgG titer Week 0 to Week 32 Serum CVA16-specific IgG titers
Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers Week 0 to Week 32 Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71
Immunogenicity of IN-B001 : GMT of CVA16 neutralizing antibody titers Week 0 to Week 32 Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against CVA16
Trial Locations
- Locations (1)
Seoul National University Hospital, Clinical Trial Center
🇰🇷Seoul, Korea, Republic of