Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)
NCT ID: NCT05113849
Last Updated: 2021-11-09
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
40 participants
INTERVENTIONAL
2021-09-16
2023-02-28
Brief Summary
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Detailed Description
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Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Cohort A (Low-dose group)
IN-B009 (Low-dose)
IN-B009 (Low-dose)
Two doses, intramuscular injection
Cohort B (High-dose group)
IN-B009 (High-dose)
IN-B009 (High-dose)
Two doses, intramuscular injection
Interventions
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IN-B009 (Low-dose)
Two doses, intramuscular injection
IN-B009 (High-dose)
Two doses, intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
19 Years
55 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
Min Geol Kim
Role: PRINCIPAL_INVESTIGATOR
Jeonju National University Hospital
Jun Ki Hwang
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Locations
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Chungbuk National University Hospital
Chungju, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Min-Gul Kim, MD, PhD
Role: primary
Jun Ki Hwang, MD, PhD
Role: primary
In-Jin Jang, MD, PhD
Role: primary
Other Identifiers
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IN_COV_101
Identifier Type: -
Identifier Source: org_study_id