Hand, Foot and Mouth DiseasePhase 1NCT04182932
Safety and Immunogenicity of CJ-40010 in Healthy Subjects
A Phase 1 study testing CJ-40010 EV71 vaccine A dose, CJ-40010 EV71 vaccine B dose and CJ-40010 CVA16 vaccine C dose in people with Hand, Foot and Mouth Disease, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- CJ-40010 EV71 vaccine A dose, CJ-40010 EV71 vaccine B dose and CJ-40010 CVA16 vaccine C dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2019to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital, Clinical Trial Center
Seoul
In-Jin Jang, MD, PhD, +82-2-2072-1666, ijjang@snu.ac.kr
In-Jin Jang, MD, PhD
About this study
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
This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects
Read the 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.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- 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
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-40010 EV71 vaccine A doseBiological
Inactivated vaccine against EV71, three doses, 28 days interval
CJ-40010 EV71 vaccine B doseBiological
Inactivated vaccine against EV71, three doses, 28 days interval
CJ-40010 CVA16 vaccine C doseBiological
Inactivated vaccine against CVA16, three doses, 28 days interval
CJ-40010 CVA16 vaccine D doseBiological
Inactivated vaccine against CVA16, three doses, 28 days interval
CJ-40010 Bivalent vaccine E doseBiological
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
CJ-40010 Bivalent vaccine high doseBiological
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
PlaceboBiological
Placebo, three doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| CJ-40010 EV71 A dose | Experimental | Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 EV71 vaccine A dose; Biological: Placebo |
| CJ-40010 EV71 B dose | Experimental | Inactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 EV71 vaccine B dose; Biological: Placebo |
| CJ-40010 CVA16 C dose | Experimental | Inactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 CVA16 vaccine C dose; Biological: Placebo |
| CJ-40010 CVA16 D dose | Experimental | Inactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 CVA16 vaccine D dose; Biological: Placebo |
| CJ-40010 Bivalent E dose | Experimental | Inactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 Bivalent vaccine E dose; Biological: Placebo |
| CJ-40010 Bivalent F dose | Experimental | Inactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: CJ-40010 Bivalent vaccine high dose; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0 to Week 32
Secondary outcomes (4)
Immunogenicity of CJ-40010 : Anti-EV71 IgG titer
Serum EV71-specific IgG titers
Measured: Week 0 to Week 32
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Serum CVA16-specific IgG titers
Measured: Week 0 to Week 32
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
Measured: Week 0 to Week 32
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
Measured: Week 0 to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start2 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182932
- Sponsor's protocol ID
- CJ_HFM_101
- Status last verified
- Dec 2019
- First submitted
- 25 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04182932
- Acronym / sponsor ID
- CJ_HFM_101
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CJ-40010 EV71 A dose | Experimental | Biological: CJ-40010 EV71 vaccine A dose, Biological: PlaceboInactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| CJ-40010 EV71 B dose | Experimental | Biological: CJ-40010 EV71 vaccine B dose, Biological: PlaceboInactivated EV71 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| CJ-40010 CVA16 C dose | Experimental | Biological: CJ-40010 CVA16 vaccine C dose, Biological: PlaceboInactivated CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| CJ-40010 CVA16 D dose | Experimental | Biological: CJ-40010 CVA16 vaccine D dose, Biological: PlaceboInactivated CVA16 vaccine(D dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| CJ-40010 Bivalent E dose | Experimental | Biological: CJ-40010 Bivalent vaccine E dose, Biological: PlaceboInactivated EV71/CVA16 vaccine(E dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| CJ-40010 Bivalent F dose | Experimental | Biological: CJ-40010 Bivalent vaccine high dose, Biological: PlaceboInactivated EV71/CVA16 vaccine(F dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJ-40010 EV71 vaccine A doseInactivated vaccine against EV71, three doses, 28 days interval | Biological | CJ-40010 EV71 A dose |
| CJ-40010 EV71 vaccine B doseInactivated vaccine against EV71, three doses, 28 days interval | Biological | CJ-40010 EV71 B dose |
| CJ-40010 CVA16 vaccine C doseInactivated vaccine against CVA16, three doses, 28 days interval | Biological | CJ-40010 CVA16 C dose |
| CJ-40010 CVA16 vaccine D doseInactivated vaccine against CVA16, three doses, 28 days interval | Biological | CJ-40010 CVA16 D dose |
| CJ-40010 Bivalent vaccine E doseInactivated vaccine against EV71/CVA16, three doses, 28 days interval | Biological | CJ-40010 Bivalent E dose |
| CJ-40010 Bivalent vaccine high doseInactivated vaccine against EV71/CVA16, three doses, 28 days interval | Biological | CJ-40010 Bivalent F dose |
| PlaceboPlacebo, three doses, 28 days interval | Biological | CJ-40010 Bivalent E dose, CJ-40010 Bivalent F dose, CJ-40010 CVA16 C dose, CJ-40010 CVA16 D dose, CJ-40010 EV71 A dose, CJ-40010 EV71 B dose |
Primary outcome
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
4 secondary outcomes
Immunogenicity of CJ-40010 : Anti-EV71 IgG titer
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : Anti-CVA16 IgG titer
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers
Time frame: Week 0 to Week 32
Immunogenicity of CJ-40010 : GMT of CVA16 neutralizing antibody titers
Time frame: Week 0 to Week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang principal investigator
Seoul National University Hospital, Dept. of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ-40010 EV71 vaccine A dose, CJ-40010 EV71 vaccine B dose and CJ-40010 CVA16 vaccine C dose in people with Hand, Foot and Mouth Disease, run by HK inno.N Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Young Wang (+82-2-6477-0286, sy.wang@kolmar.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events of CJ-40010 (Safety of CJ-40010) (time frame: Week 0 to Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.