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

NCT06099613 | Completed Phase 1

• 1 other identifier: EG-COVID-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EG-COVII

EXPERIMENTAL

Biological: EG-COVII

Interventions

EG-COVII BIOLOGICAL

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

EG-COVII

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• EyeGene Inc.: lead

Study Sites (1)

Nucleus Network Pty Ltd- Melbourne

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christina Chang, Dr.

  Nucleus Network Pty Ltd- Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 25, 2023
• Study Start: November 30, 2023
• Primary Completion: November 1, 2024
• Study Completion: February 28, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)