Status:
COMPLETED
Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult
Lead Sponsor:
EyeGene Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06099613
Start Date
November 30 2023
End Date
February 28 2025
Last Update
March 7 2025
Active Locations (1)
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1
Nucleus Network Pty Ltd- Melbourne
Melbourne, Victoria, Australia, 3004