The objective of the study is to demonstrate safety and immunogenicity of COVID-19 preventive DNA vaccine in elderly individuals.
This clinical study is a phase 1 clinical trial to investigate the safety and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in the elderly. This study is designed as single arm, open-labeled and a total of 30 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
Severance hospital
Seoul, South Korea
Gangnam Severance hospital
Seoul, South Korea
Incidence of Solicited Adverse Event(AE)s
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 Event(SAE)s
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 12 weeks after vaccination
GMFR of Antigen-specific Binding Antibody Titers
Geometric mean fold rise (GMFR) of antigen-specific binding antibody after vaccination
Time frame: Through 12 weeks after vaccination
Percentage of Subjects Who Seroconverted After Vaccination
Seroconversion defines as 4-fold increase in antibody titer after vaccination
Time frame: Through 12 weeks after vaccination
GMT of Neutralizing Antibody Level
Geometric mean titer (GMT) of neutralizing antibody after vaccination
Time frame: Through 12 weeks after vaccination
GMFR of Neutralizing Antibody Level
Geometric mean fold rise (GMFR) of neutralizing antibody after vaccination
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Time frame: Through 12 weeks after vaccination
GMSN of Spot Forming Unit (SFU) detected by interferon(IFN)-gamma ELISPOT assay
Geometric mean spot numbers (GMSN) of SFU after vaccination
Time frame: Through 12 weeks after vaccination
GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
Geometric mean fold rise (GMFR) of SFU after vaccination
Time frame: Through 12 weeks after vaccination