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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

Brief Summary:
This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: CJ-40010 EV71 vaccine A dose Biological: CJ-40010 EV71 vaccine B dose Biological: CJ-40010 CVA16 vaccine C dose Biological: CJ-40010 CVA16 vaccine D dose Biological: CJ-40010 Bivalent vaccine E dose Biological: CJ-40010 Bivalent vaccine high dose Biological: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: CJ-40010 EV71 A dose
Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Biological: CJ-40010 EV71 vaccine A dose
Inactivated vaccine against EV71, three doses, 28 days interval

Biological: Placebo
Placebo, three doses, 28 days interval

Experimental: CJ-40010 EV71 B dose
Inactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Biological: CJ-40010 EV71 vaccine B dose
Inactivated vaccine against EV71, three doses, 28 days interval

Biological: Placebo
Placebo, three doses, 28 days interval

Experimental: CJ-40010 CVA16 C dose
Inactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Biological: CJ-40010 CVA16 vaccine C dose
Inactivated vaccine against CVA16, three doses, 28 days interval

Biological: Placebo
Placebo, three doses, 28 days interval

Experimental: CJ-40010 CVA16 D dose
Inactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Biological: CJ-40010 CVA16 vaccine D dose
Inactivated vaccine against CVA16, three doses, 28 days interval

Biological: Placebo
Placebo, three doses, 28 days interval

Experimental: CJ-40010 Bivalent E dose
Inactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Biological: CJ-40010 Bivalent vaccine E dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval

Biological: Placebo
Placebo, three doses, 28 days interval

Experimental: CJ-40010 Bivalent F dose
Inactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Immunogenicity of CJ-40010 : Anti-EV71 IgG titer [ Time Frame: Week 0 to Week 32 ]
    Serum EV71-specific IgG titers

  2. Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer [ Time Frame: Week 0 to Week 32 ]
    Serum CVA16-specific IgG titers

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182932


Contacts
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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

Locations
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Korea, Republic of
Seoul National University Hospital, Clinical Trial Center Recruiting
Seoul, Korea, Republic of
Contact: In-Jin Jang, MD, PhD    +82-2-2072-1666    ijjang@snu.ac.kr   
Principal Investigator: In-Jin Jang, MD, PhD         
Sponsors and Collaborators
HK inno.N Corporation
Investigators
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Principal Investigator: In-Jin Jang Seoul National University Hospital, Dept. of Clinical Pharmacology
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT04182932    
Other Study ID Numbers: CJ_HFM_101
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs