Safety and Immunogenicity of CJ-40010 in Healthy Subjects
NCT ID: NCT04182932
Last Updated: 2019-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2019-12-02
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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CJ-40010 EV71 A dose
Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 EV71 vaccine A dose
Inactivated vaccine against EV71, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
CJ-40010 EV71 B dose
Inactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 EV71 vaccine B dose
Inactivated vaccine against EV71, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
CJ-40010 CVA16 C dose
Inactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 CVA16 vaccine C dose
Inactivated vaccine against CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
CJ-40010 CVA16 D dose
Inactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 CVA16 vaccine D dose
Inactivated vaccine against CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
CJ-40010 Bivalent E dose
Inactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 Bivalent vaccine E dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
CJ-40010 Bivalent F dose
Inactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 Bivalent vaccine high dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
Interventions
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CJ-40010 EV71 vaccine A dose
Inactivated vaccine against EV71, three doses, 28 days interval
CJ-40010 EV71 vaccine B dose
Inactivated vaccine against EV71, three doses, 28 days interval
CJ-40010 CVA16 vaccine C dose
Inactivated vaccine against CVA16, three doses, 28 days interval
CJ-40010 CVA16 vaccine D dose
Inactivated vaccine against CVA16, three doses, 28 days interval
CJ-40010 Bivalent vaccine E dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
CJ-40010 Bivalent vaccine high dose
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo
Placebo, three doses, 28 days interval
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
49 Years
ALL
Yes
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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In-Jin Jang
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital, Dept. of Clinical Pharmacology
Locations
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Seoul National University Hospital, Clinical Trial Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CJ_HFM_101
Identifier Type: -
Identifier Source: org_study_id
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