Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects
Study Details
Study Description
Brief Summary
This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IN-B001 EV71 A dose Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
Biological: IN-B001 EV71 A dose
Inactivated vaccine against EV71, three doses, 28 days interval
Biological: Placebo
Placebo, three doses, 28 days interval
|
| Experimental: IN-B001 CVA16 B dose Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
Biological: IN-B001 CVA16 B dose
Inactivated vaccine against CVA16, three doses, 28 days interval
Biological: Placebo
Placebo, three doses, 28 days interval
|
| Experimental: IN-B001 Bivalent C dose Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
Biological: IN-B001 Bivalent C dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Biological: Placebo
Placebo, three doses, 28 days interval
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital, Clinical Trial Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: In-Jin Jang, MD, Ph.D, Seoul National University Hospital, Dept. of Clinical Pharmacology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN_HFM_102