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

Primary Purpose

Hand, Foot and Mouth Disease

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

IN-B001 EV71 A dose

IN-B001 CVA16 B dose

IN-B001 Bivalent C dose

Placebo

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease

Eligibility Criteria

19 Years - 49 Years (Adult)All SexesAccepts 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

Sites / Locations

Seoul National University Hospital, Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

IN-B001 EV71 A dose

IN-B001 CVA16 B dose

IN-B001 Bivalent C dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenicity of IN-B001: Anti-EV71 IgG titer

Serum EV71-specific IgG titers

Immunogenicity of IN-B001 : Anti-CVA16 IgG titer

Serum CVA16-specific IgG titers

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

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

Full Information

NCT ID

NCT04637919

First Posted

November 16, 2020

Last Updated

November 16, 2020

Sponsor

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04637919

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HK inno.N Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand, Foot and Mouth Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IN-B001 EV71 A dose

Arm Type

Experimental

Arm Description

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

Arm Title

IN-B001 CVA16 B dose

Arm Type

Experimental

Arm Description

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

Arm Title

IN-B001 Bivalent C dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

IN-B001 EV71 A dose

Intervention Description

Inactivated vaccine against EV71, three doses, 28 days interval

Intervention Type

Biological

Intervention Name(s)

IN-B001 CVA16 B dose

Intervention Description

Inactivated vaccine against CVA16, three doses, 28 days interval

Intervention Type

Biological

Intervention Name(s)

IN-B001 Bivalent C dose

Intervention Description

Inactivated vaccine against EV71/CVA16, three doses, 28 days interval

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo, three doses, 28 days interval

Primary Outcome Measure Information:

Title

Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)

Description

Frequency and severity of adverse events up to 32 weeks post first dose

Time Frame

Week 0 to Week 32

Secondary Outcome Measure Information:

Title

Immunogenicity of IN-B001: Anti-EV71 IgG titer

Description

Serum EV71-specific IgG titers

Time Frame

Week 0 to Week 32

Title

Immunogenicity of IN-B001 : Anti-CVA16 IgG titer

Description

Serum CVA16-specific IgG titers

Time Frame

Week 0 to Week 32

Title

Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers

Description

Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71

Time Frame

Week 0 to Week 32

Title

Immunogenicity of IN-B001 : GMT of CVA16 neutralizing antibody titers

Description

Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against CVA16

Time Frame

Week 0 to Week 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Naree Shin, MS

Phone

+82-2-6477-0271

naree.shin@inno-n.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Jin Jang, MD, Ph.D

Organizational Affiliation

Seoul National University Hospital, Dept. of Clinical Pharmacology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital, Clinical Trial Center

City

Seoul

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

In-Jin Jang, MD, PhD

Phone

+82-2-2072-1910

ijjang@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

In-Jin Jang, MD, PhD

12. IPD Sharing Statement

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

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