The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers. Phase 1 of this study is designed as dose escaltion, single arm, open-labeled and a total of 60 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Severance hospital
Seoul, South Korea
Incidence of solicited adverse events
solicited local and systemic AEs after vaccination
Time frame: Through 1 year post vaccination
Incidence of unsolicited adverse events
unsolicited AEs after vaccination
Time frame: Through 1 year post vaccination
Incidence of serious adverse events
percentage of subjects with SAEs
Time frame: Through 1 year post vaccination
Geometric mean titer (GMT) of antigen-specific binding antibody titers
Change from baseline in antigen-specific binding antibody titers
Time frame: Through 1 year post vaccination
Percentage of subjects who seroconverted after vaccination
Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
Time frame: Through 1 year post vaccination
Geometric mean titer (GMT) of neutralizing antibody level
NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination
Time frame: Through 1 year post vaccination
Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers
Change from baseline in antigen-specific binding antibody titers
Time frame: Through 1 year post vaccination
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