Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: IN-B009 (Low-dose)
* Biological: IN-B009 (High-dose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A (Low-dose group)<br>IN-B009 (Low-dose) | Biological: IN-B009 (Low-dose)<br>* Two doses, intramuscular injection<br>|
| Experimental: Cohort B (High-dose group)<br>IN-B009 (High-dose) | Biological: IN-B009 (High-dose)<br>* Two doses, intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | Through Day 365 post last vaccination | 
| Cell-mediated response |  | Through Day 28 post last vaccination |