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

Hand, Foot and Mouth Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04637919
• Other study ID #: IN_HFM_102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: HK inno.N Corporation
• Contact: Naree Shin, MS
• Phone: +82-2-6477-0271
• Email: naree.shin[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• IN-B001 EV71 A dose
Inactivated vaccine against EV71, three doses, 28 days interval
• IN-B001 CVA16 B dose
Inactivated vaccine against CVA16, three doses, 28 days interval
• IN-B001 Bivalent C dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
• Placebo
Placebo, three doses, 28 days interval

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)	Frequency and severity of adverse events up to 32 weeks post first dose	Week 0 to Week 32
Secondary	Immunogenicity of IN-B001: Anti-EV71 IgG titer	Serum EV71-specific IgG titers	Week 0 to Week 32
Secondary	Immunogenicity of IN-B001 : Anti-CVA16 IgG titer	Serum CVA16-specific IgG titers	Week 0 to Week 32
Secondary	Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers	Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71	Week 0 to Week 32
Secondary	Immunogenicity of IN-B001 : GMT of CVA16 neutralizing antibody titers	Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against CVA16	Week 0 to Week 32