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

A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: EG-COVII

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Daeun Kim; Phone Number: +8223221687; Email: aliceblue@eyegene.co.kr

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Nucleus Network Pty Ltd- Melbourne
      • Contact: Nucleus Network; Phone Number: 1800243733

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EG-COVII	Biological: EG-COVII; EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of EG-COVII in healthy adult volunteers	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	7 weeks follow up

Collaborators and Investigators

• Sponsor: EyeGene Inc.
• Investigators: Principal Investigator: Christina Chang, Dr., Nucleus Network Pty Ltd- Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EG-COVID-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No