None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Low-dose group: EG-COVID 0.25mL(mRNA 50 µg)
Mid-dose group: EG-COVID 0.50mL(mRNA 100 µg)
High-dose group: EG-COVID 0.50mL(mRNA 200 µg)
Sponsors
Eyegene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. provide written informed consent before the first study-specific procedure - 19~54 years, Male and Female (Step 1 (Phase I)) - 19~85 years, Male and Female (Step 2 (Phase IIa)) 2. Participants must have a body mass index (BMI) between =18.5 and =30.0 kg/m2 at screening 3. Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion 4. Must agree not to donate blood or transfusion (including whole blood, plasma, and platelet components)
Exclusion criteria
Exclusion criteria: 1. Participant with the evidence of COVID-19 infection because of one or more of the following: 1) Positive for COVID-19 when performing RT-PCR with upper respiratory tract samples; (oropharyngeal/nasopharyngeal swab) (However, if symptoms of cough or sputum are present, additional RT-PCR is performed using a lower respiratory tract sample (sputum), and registration is possible if all are negative) 2) History of COVID-19; 3) Positive test for COVID-19 (lgM or IgG) antibody at screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited Adverse Events recorded up to 1st and 2nd vaccination;SRR, GMT, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point | — |
Secondary
| Measure | Time frame |
|---|---|
| T cell response ratio in ICS assay from before vaccination to each subsequent time point | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Han Kim
Asan Medical Center
Outcome results
None listed