A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adult

Not Applicable

Recruiting

Conditions: Certain infectious and parasitic diseases

Registration Number: KCT0006670

Lead Sponsor: Eyegene

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 45

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

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;

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures