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

Eyegene0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月2日

试验速览

暂无简介。

•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)

•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;

发起方

Eyegene