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COVID-19 VaccinePhase 1/2NCT05188469

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

A Phase 1/2 study testing EG-COVID-003, EG-COVID-001 and A: EG-COVID in people with COVID-19 Vaccine, run by EyeGene Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccine
What is being tested?
EG-COVID-003, EG-COVID-001 and A: EG-COVID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteAustralia
Study dates
22 Mar 2022to 28 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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)
  • NuvaRing®
  • Implantable contraception (e.g., Implanon)
  • Documented evidence of surgical sterilisation at least 6 months prior to screening, i.e., tubal ligation for female or vasectomy for male Rhythm methods are not considered as highly effective methods of birth control. Female participants and female partners of male participants must use contraception from the time of informed consent and for 90 days after last vaccination of study drug.
  • Female not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/mL at screening for amenorrhoeic female participants.
  • Male participants must refrain from sperm donation from start of study and for 90 days after the last vaccination of study drug.
  • Female participants who has had hysterectomy at least 6 months prior to screening must provide documented evidence of surgical sterilisation and are not required to use double barrier contraception where this is the usual and preferred lifestyle.
  • Participants who are in same-sex relationships are not required to use contraception. Abstinence is acceptable where this is the usual and preferred lifestyle.

Who cannot join

  • 1. 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;
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  • 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
  • Hepatobiliary, renal, endocrine, urinary, musculoskeletal or other disorders judged to be clinically significant by the investigator 11. History of SARS-CoV or MERS-CoV infection; 12. History of allergy or hypersensitivity reaction to any components of study vaccine; 13. History of serious adverse reaction, allergy or hypersensitivity reaction to any vaccination; 14. History of platelet-related disease or hemorrhagic disease, or have a history of severe bleeding or bruising after intramuscular injection (IM) or venipuncture, or are taking anticoagulants; (However, according to the judgment of the investigators, there can be involved when using a low dose of an anticoagulant (eg, aspirin at 100mg/day or less)) 15. History of urticaria within 5 years before the first vaccination; 16. History of hereditary or idiopathic angioneurotic edema; 17.History of organ or bone marrow transplantation; 18. History or suspicion of illegal substance use or alcohol abuse within the past 6 months before the first vaccination; 19. Receipt of chronic use of the following drugs within 6 months before the first vaccination:
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  • Immunosuppressants and immunomodulators: Azathioprine, cyclosporine, interferon, G-CSF, tacrolimus, everolimus, sirolimus, cyclophosphamide, 6-mercaptopurine, methotrexate, rapamycin, leflunomide, etc.
  • Systemic steroids: When a dose exceeding 10 mg/day and has been used for more than 14 consecutive days based on prednisolone (However, external steroids, nasal sprays, inhalants, and eye drops are permitted regardless of the dosage) 20. History of dependent psychotropic or opioid drug within 6 months before the first vaccination; 21. Participated in an interventional clinical study except for EG-COVID-102 study (step 1) within 6 months prior to the screening visit or plans to do so while participating in this study; 22. Participant has been vaccinated or plan to vaccinate any within 4 weeks before/after each study vaccine; 23. Participant has received immunoglobulin or blood-derived products within 3 months prior to the first vaccination, or those who plan to administer it during the study; 24. Participant scheduled for surgery while participating in this study; 25. Pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 26. Any other reason that, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Holdsworth House

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: 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

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

Read the 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.

Being tested
EG-COVID-003, EG-COVID-001, A: EG-COVID, B: EG-COVID, C: EG-COVARo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EG-COVID-003Drug

    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-001Drug

    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

  • A: EG-COVIDDrug

    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

  • B: EG-COVIDDrug

    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

  • C: EG-COVARoDrug

    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

Study groups in NCT05188469
Study groupRoleWhat they receive
EG-COVID-003ExperimentalSubjects 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
Receives: Drug: EG-COVID-003
EG-COVID-001ExperimentalSubjects 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
Receives: Drug: EG-COVID-001
A: EG-COVIDExperimentalSubjects 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
Receives: Drug: A: EG-COVID
B: EG-COVIDExperimentalSubjects 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
Receives: Drug: B: EG-COVID
C: EG-COVARoExperimentalSubjects 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
Receives: Drug: C: EG-COVARo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    [Safety and Tolerability]

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

  2. 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]

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

  3. The incidence and severity of injection site reactions (ISRs)

    [Safety and Tolerability]

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

Secondary outcomes (1)

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

    Participants with a significant increase of anti-SARS-CoV-2 antibodies [Explore the Immunogenicity]

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2022
  2. Study start22 Mar 2022
  3. Primary completion29 May 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188469
Sponsor's protocol ID
EG-COVID-102
Status last verified
Mar 2025
First submitted
6 Jan 2022
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EG-COVID-003, EG-COVID-001 and A: EG-COVID in people with COVID-19 Vaccine, run by EyeGene Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Day 0 through End of Study (up to 26 weeks after last dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05188469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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