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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Two doses, intramuscular injection
Two doses, intramuscular injection
Chungbuk National University Hospital
Chungju, South Korea
RECRUITINGJeonbuk National University Hospital
Jeonju, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGOccurrence rate of Immediate Adverse Reaction (IAR)
Time frame: Through 30 minutes post each vaccination (2 hours for sentinel participants)
Occurrence rate of solicited local and systemic AE
Time frame: Through Day 7 post each vaccination
Occurrence rate of unsolicited AE
Time frame: Through Day 28 post each vaccination
Occurrence rate of SAEs, MAAEs, AESIs
Time frame: Through Day 365 post last vaccination
GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA
Time frame: Through Day 365 post last vaccination
GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA
Time frame: Through Day 365 post last vaccination
Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer
Time frame: Through Day 365 post last vaccination
GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Time frame: Through Day 365 post last vaccination
GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
Time frame: 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
Time frame: Through Day 365 post last vaccination
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Cell-mediated response
Time frame: Through Day 28 post last vaccination