A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- EyeGene Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of EG-COVII in healthy adult volunteers
Study Overview
Brief Summary
This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
Detailed Description
Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 the time of screening;
- •Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster;
- •The last authorised COVID-19 vaccination, the participants received, should be more than 16 weeks prior to the first IP vaccination;
Exclusion Criteria
- •Participant with the evidence of COVID-19 infection at screening (Positive for COVID-19 with RT-PCR test with nasal mid-turbinate specimen);
- •Participant who has the history of COVID-19 infection within 6 months from the first IP vaccination;
- •Close contact with a person infected with COVID-19 within 2 weeks prior to the first IP vaccination;
Arms & Interventions
EG-COVII
Intervention: EG-COVII (Biological)
Outcomes
Primary Outcomes
Safety and tolerability of EG-COVII in healthy adult volunteers
Time Frame: 7 weeks follow up
Number of participants with adverse events (AEs) Number of participants with abnormal clinical laboratory results (hematology /chemistry /urinalysis) Number of participants with abnormal vital sign Number of participants with abnormal physical examination results
Secondary Outcomes
No secondary outcomes reported