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

NCT04637919 | Unknown Phase 1

• 1 other identifier: IN_HFM_102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Immunogenicity of IN-B001: Anti-EV71 IgG titer

  Week 0 to Week 32

• Immunogenicity of IN-B001 : Anti-CVA16 IgG titer

  Week 0 to Week 32

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

  Week 0 to Week 32

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

  Week 0 to Week 32

Study Arms (3)

IN-B001 EV71 A dose

EXPERIMENTAL

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

Biological: IN-B001 EV71 A dose; Biological: Placebo

IN-B001 CVA16 B dose

EXPERIMENTAL

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

Biological: IN-B001 CVA16 B dose; Biological: Placebo

IN-B001 Bivalent C dose

EXPERIMENTAL

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

Biological: IN-B001 Bivalent C dose; Biological: Placebo

Interventions

IN-B001 EV71 A dose BIOLOGICAL

Inactivated vaccine against EV71, three doses, 28 days interval

IN-B001 EV71 A dose

IN-B001 CVA16 B dose BIOLOGICAL

Inactivated vaccine against CVA16, three doses, 28 days interval

IN-B001 CVA16 B dose

IN-B001 Bivalent C dose BIOLOGICAL

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

IN-B001 Bivalent C dose

Placebo BIOLOGICAL

Placebo, three doses, 28 days interval

IN-B001 Bivalent C dose; IN-B001 CVA16 B dose; IN-B001 EV71 A dose

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• In-Jin Jang, MD, Ph.D

  Seoul National University Hospital, Dept. of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naree Shin, MS

CONTACT

+82-2-6477-0271; naree.shin@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

KR (1)