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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Low-dose group) | Experimental | IN-B009 (Low-dose) |
|
| Cohort B (High-dose group) | Experimental | IN-B009 (High-dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-B009 (Low-dose) | Biological | Two doses, intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence rate of Immediate Adverse Reaction (IAR) | Through 30 minutes post each vaccination (2 hours for sentinel participants) | |
| Occurrence rate of solicited local and systemic AE | Through Day 7 post each vaccination | |
| Occurrence rate of unsolicited AE | Through Day 28 post each vaccination | |
| Occurrence rate of SAEs, MAAEs, AESIs | Through Day 365 post last vaccination | |
| GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA | Through Day 365 post last vaccination | |
| GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA | Through Day 365 post last vaccination | |
| Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer | Through Day 365 post last vaccination | |
| GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay | Through Day 365 post last vaccination | |
| GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naree Shin, MS | Contact | +82-2-6477-0271 | naree.shin@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| In Jin Jang | Seoul National University Hospital | Principal Investigator |
| Min Geol Kim | Jeonju National University Hospital | Principal Investigator |
| Jun Ki Hwang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Recruiting | Chungju | South Korea |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| IN-B009 (High-dose) |
| Biological |
Two doses, intramuscular injection |
|
| Through Day 365 post last vaccination |
| Cell-mediated response | Through Day 28 post last vaccination |
| Chungbuk National University Hospital |
| Principal Investigator |
| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |