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 single arm, open-labeled and a total of 20 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
185
KyungHee University Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Ajou University Hospital
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
GMT of Antigen-specific Binding Antibody Titers
Geometric mean titer (GMT) of antigen-specific binding antibody after vaccination
Time frame: Through 1 year post vaccination
GMFR of Antigen-specific Binding Antibody Titers
Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination
Time frame: Through 1 year post vaccination
Percentage of Subjects Who Seroconverted After Vaccination
Seroconversion defines when FRNT50 is detected more than four times from the baseline after vaccination
Time frame: Through 1 year post vaccination
GMT and GMFR of Neutralizing Antibody Level
Geometric mean titer (GMT) and Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination
Time frame: Through 1 year post vaccination
GMFR of Neutralizing Antibody Level
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Suwon, South Korea
Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination
Time frame: Through 1 year post vaccination
GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
Geometric mean spot numbers (GMSN) and Geometric mean fold rise (GMFR) of SFU after vaccination
Time frame: Through 1 year post vaccination