Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: EG-COVII

• Registration Number: NCT06099613
• Lead Sponsor: EyeGene Inc.

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 Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-25
• Study Start: 2023-11-30
• Primary Completion: 2024-11-01
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EG-COVII	EG-COVII	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of EG-COVII in healthy adult volunteers	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

Trial Locations

Locations (1)

Nucleus Network Pty Ltd- Melbourne; 🇦🇺 Melbourne, Victoria, Australia