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

NCT05188469 | Completed Phase 1

• 1 other identifier: EG-COVID-102
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (3)

• incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  \[Safety and Tolerability\]

  Day 0 through End of Study (up to 26 weeks after last dose)

• Number of participants with Clinically significant abnormality findings

  Physical examination finding/s, vital signs, 12-lead electrocardiograms (ECGs), or laboratory test results \[Safety and Tolerability\]

  Day 0 through End of Study (up to 26 weeks after last dose)

• The incidence and severity of injection site reactions (ISRs)

  \[Safety and Tolerability\]

  Day 0 through End of Study (up to 26 weeks after last dose)

Secondary Outcomes (1)

• To assess the immune responses profiles of EG-COVID and EG-COVARo in healthy volunteers after vaccinations

  Day 0 through End of Study (up to 26 weeks after last dose)

Other Outcomes (1)

• Ratio of severity of symptoms via COVID-19 infection confirmed by RT-PCR test after 2 weeks of second or third vaccination through end of study (EOS).

  Day 0 through End of Study (up to 26 weeks after last dose)

Study Arms (5)

EG-COVID-003

EXPERIMENTAL

Subjects will receive one single IM vaccination, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) Component Description (per dose): EG-COVID-003 0.5mL (mRNA 100μg) Route of administration: Intramuscular injection

Drug: EG-COVID-003

EG-COVID-001

EXPERIMENTAL

Subjects will receive one single IM vaccination, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) Component Description (per dose): EG-COVID-001 0.5mL (mRNA 200μg) Route of administration: Intramuscular injection

Drug: EG-COVID-001

A: EG-COVID

EXPERIMENTAL

Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 0.5mL (mRNA 400μg) Route of administration: Intramuscular injection

Drug: A: EG-COVID

B: EG-COVID

EXPERIMENTAL

Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 1mL (mRNA 800μg) Route of administration: Intramuscular injection

Drug: B: EG-COVID

C: EG-COVARo

EXPERIMENTAL

Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVARo 0.5mL (mRNA 800μg) Route of administration: Intramuscular injection

Drug: C: EG-COVARo

Interventions

EG-COVID-003 DRUG

Subjects will receive one, two or three single IM vaccination(s), 3 weeks apart, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) EG-COVID-003 0.5mL (mRNA 100μg) Route of administration: Intramuscular injection

EG-COVID-003

EG-COVID-001 DRUG

Subjects will receive one, two or three single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) EG-COVID-001 0.5mL (mRNA 200μg) Route of administration: Intramuscular injection

EG-COVID-001

A: EG-COVID DRUG

Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 0.5mL (mRNA 400μg) Route of administration: Intramuscular injection

A: EG-COVID

B: EG-COVID DRUG

Subjects will receive two single IM vaccination(s), 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 1mL (mRNA 800μg) Route of administration: Intramuscular injection

B: EG-COVID

C: EG-COVARo DRUG

Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVARo 0.5mL (mRNA 800μg) Route of administration: Intramuscular injection

C: EG-COVARo

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 time of screening;
• Have received last COVID-19 vaccination more than 3 months ago (more than 90 days) \[Only Step 1\]
• Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster. \[Only Step 2\]
• 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. \[Only Step 2\]
• Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening;
• Availability to volunteer for the entire study duration and be willing to adhere to all protocol requirements;
• Must have a negative urine pregnancy test on the day of dosing prior to each vaccination;
• Must agree not to donate blood or receive transfusion (including whole blood, plasma, and platelet components).
• 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.
• Highly effective double-barrier contraception is defined as use of a condom AND one of the following:
• Birth control pills (The Pill)
• Depot or injectable birth control
• IUD (Intrauterine Device)
• Birth Control Patch (e.g., Ortho Evra)

You may not qualify if:

• \. Participant with the evidence of COVID-19 infection at screening because of one or more of the following:
• 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)
• 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;
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• According to the doctor's opinion, COVID-19 is suspected as a clinical symptom;
• 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:
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• 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
• Serious cardiovascular disease: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
• Nervous system: Epilepsy, seizure (Within 3 years before the first vaccination), migraine, stroke, encephalopathy, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, etc.
• Diagnosis of malignancy within the previous 10 years before the first vaccination (except basal cell and squamous cell carcinoma)
• Autoimmune diseases, including autoimmune hypothyroidism or psoriasis
• Immunodeficiency disease

Sponsors & Collaborators

• EyeGene Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Holdsworth House

Sydney, New South Wales, 2010, Australia

Location

Study Officials

• Mark Bloch, A/Prof

  Holdsworth House

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 12, 2022
• Study Start: March 22, 2022
• Primary Completion: May 29, 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)