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COMPLETEDPHASE1/PHASE2

Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

A Phase I/IIa (Multi-center, Open-label, Phase I and Multi-center, Open-label, Phase IIa ) Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

NCT05188469•EyeGene Inc.

View on ClinicalTrials.gov

Summary

This is Phase 1 and 2a, Multi-center, Open-label study designed to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo vaccine in Healthy Adult Volunteers

Detailed Description

Subjects will undergo a Screening period beginning up to 14 days prior to enrollment, the vaccination(s) will be administered on Day 0 and Day 21, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable). Subjects will be enrolled prior to vaccination on Day 0, to one (1) of two (2) or three (3) treatment groups.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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;
•2. Healthy volunteers aged above 18 years at time of screening;
•3. Have received last COVID-19 vaccination more than 3 months ago (more than 90 days) \[Only Step 1\]
•4. Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster. \[Only Step 2\]
•5. The last authorised COVID-19 vaccination, the participants received, should be more than 4 months (16 weeks) prior to the first EG-COVID or EG-COVARo vaccination. \[Only Step 2\]
•6. Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening;
•7. Availability to volunteer for the entire study duration and be willing to adhere to all protocol requirements;
•8. Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
•9. Must agree not to donate blood or receive transfusion (including whole blood, plasma, and platelet components).
•10. Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion.
+12 more criteria

Exclusion Criteria

•1\. Participant with the evidence of COVID-19 infection at screening because of one or more of the following:
•1. Positive for COVID-19 when performing RT-PCR with upper respiratory tract samples; (oropharyngeal/nasopharyngeal swab) (However, if symptoms of cough or sputum are present, additional RT-PCR is performed using a lower respiratory tract sample (sputum), and registration is possible if all are negative)
•2. History of COVID-19 \[Step 1 only\]; 2. Participant who has the history of COVID-19 infection within 6 months from the first EG-COVID or EG-COVARo vaccination; 3. Close contact with a person infected with COVID-19 within 2 weeks prior to the first EG-COVID or EG-COVARo vaccination; 4. Participants with COVID-19 specific binding antibody titer 1000 IU/mL or less or over 3000 IU/mL (≤ 1000 IU/mL or \> 3000 IU/mL) measured by a specific IgG enzyme-linked immunosorbent assay (ELISA) \[Step 2 only\]; 5. Participant who is considered to have COVID-19 symptoms because of one or more of the following within 2 weeks prior to the first EG-COVID or EG-COVARo vaccination;
•
•1. According to the doctor's opinion, COVID-19 is suspected as a clinical symptom;
•2. History of travel outside of the country and have clinical symptoms of COVID-19; 6. Healthcare workers who can participate in the treatment of COVID-19 patients, or those at high risk of exposure to SARS-CoV-2 (screening clinics and emergency room workers, workers related to COVID-19 prevention, workers involved in collecting or analysing COVID-19 samples, etc.); 7. Clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or chest X-rays performed at the screening; 8. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening; 9. Is acutely febrile or ill 72 hours prior to the first vaccination;
•* Fever is defined as a body temperature ≥38.0°Celsius / ≥100.4°Farenheit.
•* Illness is defined as symptoms due to other infectious diseases (Cough, shortness of breath, chills, muscle pain, headache, sore throat, loss of smell, or loss of taste, etc.) 10. History of a diagnosis or condition that, in the judgment of the Investigator, may affect study endpoint assessment or participant safety, specifically:
•
•1. Respiratory system: asthma, chronic obstructive pulmonary disease (COPD), daily medication administration for active tuberculosis or latent tuberculosis, received treatment due to worsening of respiratory diseases within 5 years prior to the first vaccination
+9 more criteria

Locations (1)

Holdsworth House

Sydney, New South Wales, Australia

Key Dates

Start Date

March 22, 2022

Primary Completion Date

May 29, 2024

Completion Date

February 28, 2025

Last Updated

March 7, 2025

Enrollment

ACTUAL participants

Conditions

COVID-19 Vaccine

Interventions

EG-COVID-003

DRUG

EG-COVID-001

DRUG

A: EG-COVID

DRUG

B: EG-COVID

DRUG

C: EG-COVARo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

Inclusion Criteria

Exclusion Criteria

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