Safety and Immunogenicity of CJ-40010 in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of CJ-40010 After Administration in Healthy Subjects
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 3, 2019
December 1, 2019
1.9 years
November 25, 2019
December 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 0 to Week 32
Secondary Outcomes (4)
Immunogenicity of CJ-40010 : Anti-EV71 IgG titer
Week 0 to Week 32
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Week 0 to Week 32
Immunogenicity of CJ-40010 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers
Week 0 to Week 32
Immunogenicity of CJ-40010 : GMT of CVA16 neutralizing antibody titers
Week 0 to Week 32
Study Arms (6)
CJ-40010 EV71 A dose
EXPERIMENTALInactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 EV71 B dose
EXPERIMENTALInactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 CVA16 C dose
EXPERIMENTALInactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 CVA16 D dose
EXPERIMENTALInactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 Bivalent E dose
EXPERIMENTALInactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval)
CJ-40010 Bivalent F dose
EXPERIMENTALInactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval)
Interventions
Inactivated vaccine against EV71, three doses, 28 days interval
Inactivated vaccine against EV71, three doses, 28 days interval
Inactivated vaccine against CVA16, three doses, 28 days interval
Inactivated vaccine against CVA16, three doses, 28 days interval
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
Placebo, three doses, 28 days interval
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jin Jang
Seoul National University Hospital, Dept. of Clinical Pharmacology
Central Study Contacts
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 25, 2019
First Posted
December 2, 2019
Study Start
December 2, 2019
Primary Completion
November 1, 2021
Study Completion
December 1, 2021
Last Updated
December 3, 2019
Record last verified: 2019-12