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Safety and Immunogenicity of CJ-40010 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04182932
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE December 2, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE December 2, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2019)
Frequency and severity of adverse events of CJ-40010 (Safety of CJ-40010) [ Time Frame: Week 0 to Week 32 ]
- Frequency and severity of adverse events up to 32 weeks post first dose
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
Safety of CJ-40010 vaccine in healthy volunteers [ Time Frame: Week 0 to Week 32 ]
- Frequency and severity of adverse events up to 32 weeks post first dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Immunogenicity of CJ-40010 : Anti-EV71 IgG titer [ Time Frame: Week 0 to Week 32 ]
    Serum EV71-specific IgG titers
  • Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer [ Time Frame: Week 0 to Week 32 ]
    Serum CVA16-specific IgG titers
  • Immunogenicity of CJ-40010 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers [ Time Frame: Week 0 to Week 32 ]
    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 [ Time Frame: Week 0 to Week 32 ]
    Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against CVA16
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of CJ-40010 in Healthy Subjects
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of CJ-40010 After Administration in Healthy Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hand, Foot and Mouth Disease
Intervention  ICMJE
  • Biological: CJ-40010 EV71 vaccine A dose
    Inactivated vaccine against EV71, three doses, 28 days interval
  • Biological: CJ-40010 EV71 vaccine B dose
    Inactivated vaccine against EV71, three doses, 28 days interval
  • Biological: CJ-40010 CVA16 vaccine C dose
    Inactivated vaccine against CVA16, three doses, 28 days interval
  • Biological: CJ-40010 CVA16 vaccine D dose
    Inactivated vaccine against CVA16, three doses, 28 days interval
  • Biological: CJ-40010 Bivalent vaccine E dose
    Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
  • Biological: CJ-40010 Bivalent vaccine high dose
    Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
  • Biological: Placebo
    Placebo, three doses, 28 days interval
Study Arms  ICMJE
  • Experimental: CJ-40010 EV71 A dose
    Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 EV71 vaccine A dose
    • Biological: Placebo
  • Experimental: CJ-40010 EV71 B dose
    Inactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 EV71 vaccine B dose
    • Biological: Placebo
  • Experimental: CJ-40010 CVA16 C dose
    Inactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 CVA16 vaccine C dose
    • Biological: Placebo
  • Experimental: CJ-40010 CVA16 D dose
    Inactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 CVA16 vaccine D dose
    • Biological: Placebo
  • Experimental: CJ-40010 Bivalent E dose
    Inactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 Bivalent vaccine E dose
    • Biological: Placebo
  • Experimental: CJ-40010 Bivalent F dose
    Inactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval)
    Interventions:
    • Biological: CJ-40010 Bivalent vaccine high dose
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sun Young Wang +82-2-6477-0286 sy.wang@kolmar.co.kr
Contact: Ji Yeon Nam +82-2-6477-0277 jy.nam@kolmar.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04182932
Other Study ID Numbers  ICMJE CJ_HFM_101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HK inno.N Corporation
Study Sponsor  ICMJE HK inno.N Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: In-Jin Jang Seoul National University Hospital, Dept. of Clinical Pharmacology
PRS Account HK inno.N Corporation
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP