Clinical trial NCT04637919: Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of High-dose IN-B001 After Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hand, Foot and Mouth Disease
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

Eligibility 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
* 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

Primary outcomes:
measure: Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)
timeFrame: Week 0 to Week 32
Secondary outcomes:
measure: Immunogenicity of IN-B001: Anti-EV71 IgG titer
timeFrame: Week 0 to Week 32
measure: Immunogenicity of IN-B001 : Anti-CVA16 IgG titer
timeFrame: Week 0 to Week 32
measure: Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers
timeFrame: Week 0 to Week 32
measure: Immunogenicity of IN-B001 : GMT of CVA16 neutralizing antibody titers
timeFrame: Week 0 to Week 32
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital, Dept. of Clinical Pharmacology
name: In-Jin Jang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: