Hand, Foot and Mouth DiseasePhase 1NCT04637919
Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects
A Phase 1 study testing IN-B001 EV71 A dose, IN-B001 CVA16 B dose and IN-B001 Bivalent 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 high-dose IN-B001 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?
- IN-B001 EV71 A dose, IN-B001 CVA16 B dose and IN-B001 Bivalent C dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2020to 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 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
- Determined by the investigator to be eligible for study participation based on the results of screening tests
- Intact deltoid muscle that allows administration of the investigational product
- Consent to use medically acceptable contraception throughout the study
- Negative finding from a pregnancy test (urine hCG) at the time of the screening for women of childbearing potential
- 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 within 3 months prior to the 1st IP administration
- Medical history of an anaphylactic or similar acute reaction to IN-B001 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
Show all 16Show fewer
- History of a Guillain Barre syndrome
- Excessive caffeine intake or continuous alcohol consumption 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 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
Seoul National University Hospital, Clinical Trial Center
Seoul
In-Jin Jang, MD, PhD, +82-2-2072-1910, 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 High-dose IN-B001 After Administration in Healthy Subjects
This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 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
- IN-B001 EV71 A dose, IN-B001 CVA16 B dose, IN-B001 Bivalent C dose, Placebo
- 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.
IN-B001 EV71 A doseBiological
Inactivated vaccine against EV71, three doses, 28 days interval
IN-B001 CVA16 B doseBiological
Inactivated vaccine against CVA16, three doses, 28 days interval
IN-B001 Bivalent C doseBiological
Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
PlaceboBiological
Placebo, three doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| IN-B001 EV71 A dose | Experimental | Inactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: IN-B001 EV71 A dose; Biological: Placebo |
| IN-B001 CVA16 B dose | Experimental | Inactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: IN-B001 CVA16 B dose; Biological: Placebo |
| IN-B001 Bivalent C dose | Experimental | Inactivated EV71/CVA16 vaccine(C dose) or placebo in 10 healthy adults (three doses, 28 days interval) Receives: Biological: IN-B001 Bivalent C 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 IN-B001 (Safety of IN-B001)
Frequency and severity of adverse events up to 32 weeks post first dose
Measured: Week 0 to Week 32
Secondary outcomes (4)
Immunogenicity of IN-B001: Anti-EV71 IgG titer
Serum EV71-specific IgG titers
Measured: Week 0 to Week 32
Immunogenicity of IN-B001 : Anti-CVA16 IgG titer
Serum CVA16-specific IgG titers
Measured: Week 0 to Week 32
Immunogenicity of IN-B001 : 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 IN-B001 : 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 posted20 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionDec 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, Ph.D, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637919
- Sponsor's protocol ID
- IN_HFM_102
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 20 Nov 2020
- 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 20 Nov 2020. 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 High-dose IN-B001 After Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04637919
- Acronym / sponsor ID
- IN_HFM_102
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Nov 2020 (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 high-dose IN-B001 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
- 3
| Arm | Type | Receives |
|---|---|---|
| IN-B001 EV71 A dose | Experimental | Biological: IN-B001 EV71 A dose, Biological: PlaceboInactivated EV71 vaccine(A dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| IN-B001 CVA16 B dose | Experimental | Biological: IN-B001 CVA16 B dose, Biological: PlaceboInactivated CVA16 vaccine(B dose) or placebo in 10 healthy adults (three doses, 28 days interval) |
| IN-B001 Bivalent C dose | Experimental | Biological: IN-B001 Bivalent C dose, Biological: PlaceboInactivated EV71/CVA16 vaccine(C 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 (7 listed)
- Healthy adult 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
- Determined by the investigator to be eligible for study participation based on the results of screening tests
- Intact deltoid muscle that allows administration of the investigational product
- Consent to use medically acceptable contraception throughout the study
Key exclusion criteria (16 listed)
- History of a hand-foot-mouth disease or history of a disease related with enterovirus(EV) infection within 3 months prior to the 1st IP administration
- Medical history of an anaphylactic or similar acute reaction to IN-B001 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 |
|---|---|---|
| IN-B001 EV71 A doseInactivated vaccine against EV71, three doses, 28 days interval | Biological | IN-B001 EV71 A dose |
| IN-B001 CVA16 B doseInactivated vaccine against CVA16, three doses, 28 days interval | Biological | IN-B001 CVA16 B dose |
| IN-B001 Bivalent C doseInactivated vaccine against EV71/CVA16, three doses, 28 days interval | Biological | IN-B001 Bivalent C dose |
| PlaceboPlacebo, three doses, 28 days interval | Biological | IN-B001 Bivalent C dose, IN-B001 CVA16 B dose, IN-B001 EV71 A dose |
Primary outcome
Frequency and severity of adverse events of IN-B001 (Safety of IN-B001)
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 IN-B001: Anti-EV71 IgG titer
Time frame: Week 0 to Week 32
Immunogenicity of IN-B001 : Anti-CVA16 IgG titer
Time frame: Week 0 to Week 32
Immunogenicity of IN-B001 : Geometric mean titer (GMT) of EV71 neutralizing antibody titers
Time frame: Week 0 to Week 32
Immunogenicity of IN-B001 : 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 20 Nov 2020.
Related trials for Hand, Foot and Mouth Disease
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CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
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Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
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Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
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Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
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, MD, Ph.D 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 IN-B001 EV71 A dose, IN-B001 CVA16 B dose and IN-B001 Bivalent 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 7 inclusion and 16 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 20 Nov 2020. 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 Naree Shin, MS (+82-2-6477-0271, naree.shin@inno-n.com), 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 IN-B001 (Safety of IN-B001) (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 20 Nov 2020.