COVID-19Phase 1NCT05113849
Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)
A Phase 1 study testing IN-B009 (Low-dose) and IN-B009 (High-dose) in people with COVID-19, run by HK inno.N Corporation at 3 sites in South Korea.
Trial summary
This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- IN-B009 (Low-dose) and IN-B009 (High-dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 16 Sep 2021to Feb 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants between the ages of 18 and 55 years.
- Participants considered 'healthy' to be eligible for study participation.
- Participants who are willing and able to comply with all scheduled visits and other study procedures.
- Participants with Body mass index (BMI) within the normal range.
- Participants with deltoid muscle capable of IP injection.
- Those that agreed to using medically approved contraception.
- Female participants with potential pregnancy- Those that used medically approved contraception and has negative result at the pregnancy test.
- Capable of giving personal signed informed consent
Who cannot join
- Clinically significant symptoms prior to IP injection.
- Confirmed to be COVID-19 RT-PCR positive or to have made close contact with SARS-CoV-2 infected patient.
- History of virologically-confirmed SARS, MERS, or COVID-19.
- History of congenital or acquired immunodeficiency or autoimmune diseases.
- Positive result of hepatitis B, C, RPR test, or HIV.
- History of disorder that inhibits intramuscular injection of the vaccine.
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- History of hypersensitivity and severe allergic reaction to any of the components of IP.
- History of malignant tumor within 5 years prior to the first IP injection.
- Clinically significant chronic diseases that could cause safety concerns regarding COVID-19.
- Scheduled of , or history of surgery under general anaesthesia prior to first IP injection,
- Female participant that is pregnant or is currently breastfeeding.
- Smoker or history of smoking within 12 weeks prior to first IP injection.
- Previous vaccination or treatment for prevention of COVID-19.
- Vaccination prior to the first IP injection or scheduled of vaccination after second IP injection.
- Treated with immunoglobulin and/or blood/blood components prior to first IP injection.
- Chronic use of immunosuppressant prior to first IP injection.
- Participated in other clinical study prior to first IP injection, or scheduled to participate in other study during the study period.
- Healthcare worker or emergency response personnel.
- Conditions that may influence the evaluation of the study objectives.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Chungbuk National University Hospital
Chungju
Min-Gul Kim, MD, PhD
- Recruiting
Jeonbuk National University Hospital
Jeonju
Jun Ki Hwang, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul
In-Jin Jang, MD, PhD, +82-2-2072-1910, ijjang@snu.ac.kr
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years
This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.
Read the detailed description
Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital.
Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).
- Conditions
- COVID-19
- Being tested
- IN-B009 (Low-dose), IN-B009 (High-dose)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-B009 (Low-dose)Biological
Two doses, intramuscular injection
IN-B009 (High-dose)Biological
Two doses, intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Low-dose group) | Experimental | IN-B009 (Low-dose) Receives: Biological: IN-B009 (Low-dose) |
| Cohort B (High-dose group) | Experimental | IN-B009 (High-dose) Receives: Biological: IN-B009 (High-dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of Immediate Adverse Reaction (IAR)
Measured: Through 30 minutes post each vaccination (2 hours for sentinel participants)
Occurrence rate of solicited local and systemic AE
Measured: Through Day 7 post each vaccination
Occurrence rate of unsolicited AE
Measured: Through Day 28 post each vaccination
Occurrence rate of SAEs, MAAEs, AESIs
Measured: Through Day 365 post last vaccination
GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA
Measured: Through Day 365 post last vaccination
GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA
Measured: Through Day 365 post last vaccination
Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer
Measured: Through Day 365 post last vaccination
GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Measured: Through Day 365 post last vaccination
GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Measured: Through Day 365 post last vaccination
Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer
Measured: Through Day 365 post last vaccination
Cell-mediated response
Measured: Through Day 28 post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start16 Sep 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 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 HospitalMin Geol Kim, Principal investigator, Jeonju National University HospitalJun Ki Hwang, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113849
- Sponsor's protocol ID
- IN_COV_101
- Status last verified
- Nov 2021
- First submitted
- 29 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years
- ClinicalTrials.gov ID
- NCT05113849
- Acronym / sponsor ID
- IN_COV_101
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Nov 2021 (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 is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.
Detailed description
Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital.
Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Low-dose group) | Experimental | Biological: IN-B009 (Low-dose)IN-B009 (Low-dose) |
| Cohort B (High-dose group) | Experimental | Biological: IN-B009 (High-dose)IN-B009 (High-dose) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female participants between the ages of 18 and 55 years.
- Participants considered 'healthy' to be eligible for study participation.
- Participants who are willing and able to comply with all scheduled visits and other study procedures.
- Participants with Body mass index (BMI) within the normal range.
- Participants with deltoid muscle capable of IP injection.
Key exclusion criteria (19 listed)
- Clinically significant symptoms prior to IP injection.
- Confirmed to be COVID-19 RT-PCR positive or to have made close contact with SARS-CoV-2 infected patient.
- History of virologically-confirmed SARS, MERS, or COVID-19.
- History of congenital or acquired immunodeficiency or autoimmune diseases.
- Positive result of hepatitis B, C, RPR test, or HIV.
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-B009 (Low-dose)Two doses, intramuscular injection | Biological | Cohort A (Low-dose group) |
| IN-B009 (High-dose)Two doses, intramuscular injection | Biological | Cohort B (High-dose group) |
Primary outcome
Occurrence rate of Immediate Adverse Reaction (IAR)
Time frame: Through 30 minutes post each vaccination (2 hours for sentinel participants)
Occurrence rate of solicited local and systemic AE
Time frame: Through Day 7 post each vaccination
Occurrence rate of unsolicited AE
Time frame: Through Day 28 post each vaccination
Occurrence rate of SAEs, MAAEs, AESIs
Time frame: Through Day 365 post last vaccination
GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA
Time frame: Through Day 365 post last vaccination
GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA
Time frame: Through Day 365 post last vaccination
Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer
Time frame: Through Day 365 post last vaccination
GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Time frame: Through Day 365 post last vaccination
GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Time frame: Through Day 365 post last vaccination
Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer
Time frame: Through Day 365 post last vaccination
Cell-mediated response
Time frame: Through Day 28 post last vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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
Min Geol Kim principal investigator
Jeonju National University Hospital
Jun Ki Hwang principal investigator
Chungbuk National University Hospital
3 sites 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-B009 (Low-dose) and IN-B009 (High-dose) in people with COVID-19, run by HK inno.N Corporation at 3 sites 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 8 inclusion and 19 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Occurrence rate of Immediate Adverse Reaction (IAR) (time frame: Through 30 minutes post each vaccination (2 hours for sentinel participants)). The study lists 11 primary outcomes in all. 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 9 Nov 2021.