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

Sponsor

EyeGene Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT06099613

Collaborator

(none)

Enrollment

Location

Arm

8.3

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: EG-COVII	Phase 1/Phase 2

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

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 23, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network Pty Ltd- Melbourne	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

EyeGene Inc.

Investigators

Principal Investigator: Christina Chang, Dr., Nucleus Network Pty Ltd- Melbourne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EyeGene Inc.

ClinicalTrials.gov Identifier:

NCT06099613

Other Study ID Numbers:

EG-COVID-103

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 26, 2023