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

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: COVID-19

Treatments: Biological: IN-B009 (Low-dose); Biological: IN-B009 (High-dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113849

IN_COV_101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort A (Low-dose group)

Experimental group

Description:

IN-B009 (Low-dose)

Treatment:

Biological: IN-B009 (Low-dose)

Cohort B (High-dose group)

Experimental group

Description:

IN-B009 (High-dose)

Treatment:

Biological: IN-B009 (High-dose)