COVID-19
Conditions
Brief summary
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
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).
Interventions
BIOLOGICALIN-B009 (Low-dose)
Two doses, intramuscular injection
BIOLOGICALIN-B009 (High-dose)
Two doses, intramuscular injection
Sponsors
HK inno.N Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactNaree Shin, MS
Outcome results
None listed