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Safety and Immunogenicity of CJ-40010 in Healthy Subjects

Primary Purpose

Hand, Foot and Mouth Disease

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-40010 EV71 vaccine A dose
CJ-40010 EV71 vaccine B dose
CJ-40010 CVA16 vaccine C dose
CJ-40010 CVA16 vaccine D dose
CJ-40010 Bivalent vaccine E dose
CJ-40010 Bivalent vaccine high dose
Placebo
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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 men and women 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

    *BMI (kg/m2) = Body weight (kg) / {height (m)}2

  • Determined by the investigator to be eligible for study participation based on the results of screening tests (medical examination by interview, physical examination, vital signs, ECG, and clinical laboratory tests) conducted within 4 weeks of the 1st IP administration
  • Intact deltoid muscle* that allows administration of the investigational product

    *Those who have a wound, scar, tattoo, skin disorder or infection on the expected investigational product administration site (deltoid muscle) that can affect safety evaluation cannot enter the study

  • Consent to use medically acceptable contraception* throughout the study

    *Medically acceptable contraception: Use of an intrauterine device with a demonstrated pregnancy failure rate, concurrent use of a barrier method (male or female) and spermicide, surgical contraception of the subject or partner (vasectomy, salpingectomy/tubal ligation, hysterectomy, bilateral oophorectomy)

  • Negative finding from a pregnancy test (urine hCG) at the time of the screening visit, after using medically acceptable contraception prior to 30 days of screening for women of childbearing potential*

    *Women of childbearing potential: Women who have not passed 1 year after menopause or not surgically sterilized (hysterectomy, bilateral oophorectomy)

  • 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 such as herpangina, viral meningitis, encephalitis, acute hemorrhagic conjunctivitis or myocarditis within 3 months prior to the 1st IP administration
  • Medical history of an anaphylactic or similar acute reaction to CJ-40010 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

    • e.g., Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus
    • High dose corticosteroids (continuous use for 14 days or more at ≥20 mg/day for Prednisolone. However, use of inhaled, intranasal or topical corticosteroids is allowed irrespective of the administered dose).
  • History of a Guillain Barre syndrome
  • Excessive caffeine intake (>5 units/day) or continuous alcohol consumption (>21 units/week, 1 unit = 10 g of pure alcohol) 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 (however, those who administered an allowed drug as specified in the other exclusion criterion can enter the study) 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 CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CJ-40010 EV71 A dose

CJ-40010 EV71 B dose

CJ-40010 CVA16 C dose

CJ-40010 CVA16 D dose

CJ-40010 Bivalent E dose

CJ-40010 Bivalent F dose

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events of CJ-40010 (Safety of CJ-40010)
- Frequency and severity of adverse events up to 32 weeks post first dose

Secondary Outcome Measures

Immunogenicity of CJ-40010 : Anti-EV71 IgG titer
Serum EV71-specific IgG titers
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Serum CVA16-specific IgG titers
Immunogenicity of CJ-40010 : 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 CJ-40010 : 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

First Posted
November 25, 2019
Last Updated
December 1, 2019
Sponsor
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04182932
Brief Title
Safety and Immunogenicity of CJ-40010 in Healthy Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of CJ-40010 After Administration in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
November 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the safety and immunogenicity of CJ-40010 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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CJ-40010 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
CJ-40010 EV71 B dose
Arm Type
Experimental
Arm Description
Inactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Arm Title
CJ-40010 CVA16 C dose
Arm Type
Experimental
Arm Description
Inactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Arm Title
CJ-40010 CVA16 D dose
Arm Type
Experimental
Arm Description
Inactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Arm Title
CJ-40010 Bivalent E dose
Arm Type
Experimental
Arm Description
Inactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Arm Title
CJ-40010 Bivalent F dose
Arm Type
Experimental
Arm Description
Inactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Intervention Type
Biological
Intervention Name(s)
CJ-40010 EV71 vaccine A dose
Intervention Description
Inactivated vaccine against EV71, three doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
CJ-40010 EV71 vaccine B dose
Intervention Description
Inactivated vaccine against EV71, three doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
CJ-40010 CVA16 vaccine C dose
Intervention Description
Inactivated vaccine against CVA16, three doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
CJ-40010 CVA16 vaccine D dose
Intervention Description
Inactivated vaccine against CVA16, three doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
CJ-40010 Bivalent vaccine E dose
Intervention Description
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
CJ-40010 Bivalent vaccine high 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 CJ-40010 (Safety of CJ-40010)
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 CJ-40010 : Anti-EV71 IgG titer
Description
Serum EV71-specific IgG titers
Time Frame
Week 0 to Week 32
Title
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Description
Serum CVA16-specific IgG titers
Time Frame
Week 0 to Week 32
Title
Immunogenicity of CJ-40010 : 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 CJ-40010 : 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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult men and women 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 *BMI (kg/m2) = Body weight (kg) / {height (m)}2 Determined by the investigator to be eligible for study participation based on the results of screening tests (medical examination by interview, physical examination, vital signs, ECG, and clinical laboratory tests) conducted within 4 weeks of the 1st IP administration Intact deltoid muscle* that allows administration of the investigational product *Those who have a wound, scar, tattoo, skin disorder or infection on the expected investigational product administration site (deltoid muscle) that can affect safety evaluation cannot enter the study Consent to use medically acceptable contraception* throughout the study *Medically acceptable contraception: Use of an intrauterine device with a demonstrated pregnancy failure rate, concurrent use of a barrier method (male or female) and spermicide, surgical contraception of the subject or partner (vasectomy, salpingectomy/tubal ligation, hysterectomy, bilateral oophorectomy) Negative finding from a pregnancy test (urine hCG) at the time of the screening visit, after using medically acceptable contraception prior to 30 days of screening for women of childbearing potential* *Women of childbearing potential: Women who have not passed 1 year after menopause or not surgically sterilized (hysterectomy, bilateral oophorectomy) 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 such as herpangina, viral meningitis, encephalitis, acute hemorrhagic conjunctivitis or myocarditis within 3 months prior to the 1st IP administration Medical history of an anaphylactic or similar acute reaction to CJ-40010 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 e.g., Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus High dose corticosteroids (continuous use for 14 days or more at ≥20 mg/day for Prednisolone. However, use of inhaled, intranasal or topical corticosteroids is allowed irrespective of the administered dose). History of a Guillain Barre syndrome Excessive caffeine intake (>5 units/day) or continuous alcohol consumption (>21 units/week, 1 unit = 10 g of pure alcohol) 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 (however, those who administered an allowed drug as specified in the other exclusion criterion can enter the study) 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
Sun Young Wang
Phone
+82-2-6477-0286
Email
sy.wang@kolmar.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Yeon Nam
Phone
+82-2-6477-0277
Email
jy.nam@kolmar.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, MD, PhD
Phone
+82-2-2072-1666
Email
ijjang@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of CJ-40010 in Healthy Subjects

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