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

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.

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).

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.