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

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

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

Study Overview

• Status: Unknown
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Biological: Placebo; Biological: IN-B001 EV71 A dose; Biological: IN-B001 CVA16 B dose; Biological: IN-B001 Bivalent C dose

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Naree Shin, MS; Phone Number: +82-2-6477-0271; Email: naree.shin@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital, Clinical Trial Center
    • Contact: In-Jin Jang, MD, PhD; Phone Number: +82-2-2072-1910; Email: ijjang@snu.ac.kr
    • Principal Investigator: In-Jin Jang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of IN-B001: Anti-EV71 IgG titer	Serum EV71-specific IgG titers	Week 0 to Week 32
Immunogenicity of IN-B001 : Anti-CVA16 IgG titer	Serum CVA16-specific IgG titers	Week 0 to Week 32
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
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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: In-Jin Jang, MD, Ph.D, Seoul National University Hospital, Dept. of Clinical Pharmacology

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: IN_HFM_102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No