A Phase I/IIa (Multi-center, Open-label, Phase I and Multi-center, Open-label, Phase IIa ) Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- EG-COVID-003
- Conditions
- COVID-19 Vaccine
- Sponsor
- EyeGene Inc.
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is Phase 1 and 2a, Multi-center, Open-label study designed to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo vaccine in Healthy Adult Volunteers
Detailed Description
Subjects will undergo a Screening period beginning up to 14 days prior to enrollment, the vaccination(s) will be administered on Day 0 and Day 21, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable). Subjects will be enrolled prior to vaccination on Day 0, to one (1) of two (2) or three (3) treatment groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure;
- •Healthy volunteers aged above 18 years at time of screening;
- •Have received last COVID-19 vaccination more than 3 months ago (more than 90 days) \[Only Step 1\]
- •Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster. \[Only Step 2\]
- •The last authorised COVID-19 vaccination, the participants received, should be more than 4 months (16 weeks) prior to the first EG-COVID or EG-COVARo vaccination. \[Only Step 2\]
- •Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening;
- •Availability to volunteer for the entire study duration and be willing to adhere to all protocol requirements;
- •Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
- •Must agree not to donate blood or receive transfusion (including whole blood, plasma, and platelet components).
- •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.
Exclusion Criteria
- •Participant with the evidence of COVID-19 infection at screening because of one or more of the following:
- •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)
- •History of COVID-19 \[Step 1 only\];
- •Participant who has the history of COVID-19 infection within 6 months from the first EG-COVID or EG-COVARo vaccination;
- •Close contact with a person infected with COVID-19 within 2 weeks prior to the first EG-COVID or EG-COVARo vaccination;
- •Participants with COVID-19 specific binding antibody titer 1000 IU/mL or less or over 3000 IU/mL (≤ 1000 IU/mL or \> 3000 IU/mL) measured by a specific IgG enzyme-linked immunosorbent assay (ELISA) \[Step 2 only\];
- •Participant who is considered to have COVID-19 symptoms because of one or more of the following within 2 weeks prior to the first EG-COVID or EG-COVARo vaccination;
- •According to the doctor's opinion, COVID-19 is suspected as a clinical symptom;
- •History of travel outside of the country and have clinical symptoms of COVID-19;
- •Healthcare workers who can participate in the treatment of COVID-19 patients, or those at high risk of exposure to SARS-CoV-2 (screening clinics and emergency room workers, workers related to COVID-19 prevention, workers involved in collecting or analysing COVID-19 samples, etc.);
Arms & Interventions
EG-COVID-003
Subjects will receive one single IM vaccination, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) Component Description (per dose): EG-COVID-003 0.5mL (mRNA 100μg) Route of administration: Intramuscular injection
Intervention: EG-COVID-003
EG-COVID-001
Subjects will receive one single IM vaccination, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) Component Description (per dose): EG-COVID-001 0.5mL (mRNA 200μg) Route of administration: Intramuscular injection
Intervention: EG-COVID-001
Outcomes
Primary Outcomes
incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: Day 0 through End of Study (up to 26 weeks after last dose)
\[Safety and Tolerability\]
Number of participants with Clinically significant abnormality findings
Time Frame: Day 0 through End of Study (up to 26 weeks after last dose)
Physical examination finding/s, vital signs, 12-lead electrocardiograms (ECGs), or laboratory test results \[Safety and Tolerability\]
The incidence and severity of injection site reactions (ISRs)
Time Frame: Day 0 through End of Study (up to 26 weeks after last dose)
\[Safety and Tolerability\]
Secondary Outcomes
- To assess the immune responses profiles of EG-COVID and EG-COVARo in healthy volunteers after vaccinations(Day 0 through End of Study (up to 26 weeks after last dose))