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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05188469




Registration number
NCT05188469
Ethics application status
Date submitted
6/01/2022
Date registered
12/01/2022

Titles & IDs
Public title
Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers
Scientific 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
Secondary ID [1] 0 0
EG-COVID-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Vaccine 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EG-COVID-003
Treatment: Drugs - EG-COVID-001
Treatment: Drugs - A: EG-COVID
Treatment: Drugs - B: EG-COVID
Treatment: Drugs - C: EG-COVARo

Experimental: EG-COVID-003 - 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

Experimental: EG-COVID-001 - 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

Experimental: A: EG-COVID - 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

Experimental: B: EG-COVID - 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

Experimental: C: EG-COVARo - 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


Treatment: Drugs: EG-COVID-003
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

Treatment: Drugs: EG-COVID-001
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

Treatment: Drugs: A: EG-COVID
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

Treatment: Drugs: B: EG-COVID
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

Treatment: Drugs: C: EG-COVARo
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
Day 0 through End of Study (up to 26 weeks after last dose)
Primary outcome [2] 0 0
Number of participants with Clinically significant abnormality findings
Timepoint [2] 0 0
Day 0 through End of Study (up to 26 weeks after last dose)
Primary outcome [3] 0 0
The incidence and severity of injection site reactions (ISRs)
Timepoint [3] 0 0
Day 0 through End of Study (up to 26 weeks after last dose)
Secondary outcome [1] 0 0
To assess the immune responses profiles of EG-COVID and EG-COVARo in healthy volunteers after vaccinations
Timepoint [1] 0 0
Day 0 through End of Study (up to 26 weeks after last dose)

Eligibility
Key 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.

Highly effective double-barrier contraception is defined as use of a condom AND one of the following:

1. Birth control pills (The Pill)
2. Depot or injectable birth control
3. IUD (Intrauterine Device)
4. Birth Control Patch (e.g., Ortho Evra)
5. NuvaRing®
6. Implantable contraception (e.g., Implanon)
7. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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;

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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:

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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
2. Serious cardiovascular disease: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
3. Nervous system: Epilepsy, seizure (Within 3 years before the first vaccination), migraine, stroke, encephalopathy, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, etc.
4. Diagnosis of malignancy within the previous 10 years before the first vaccination (except basal cell and squamous cell carcinoma)
5. Autoimmune diseases, including autoimmune hypothyroidism or psoriasis
6. Immunodeficiency disease
7. 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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1. Immunosuppressants and immunomodulators: Azathioprine, cyclosporine, interferon, G-CSF, tacrolimus, everolimus, sirolimus, cyclophosphamide, 6-mercaptopurine, methotrexate, rapamycin, leflunomide, etc.
2. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
EyeGene Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Bloch, A/Prof
Address 0 0
Holdsworth House
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05188469