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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099613
• Other study ID #: EG-COVID-103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 23, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: EyeGene Inc.
• Contact: Daeun Kim
• Phone: +8223221687
• Email: aliceblue[@]eyegene.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• EG-COVII
EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd- Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
EyeGene Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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