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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| C: EG-COVARo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | Day 0 through End of Study (up to 26 weeks after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | [Explore the Immunogenicity] | Day 0 through End of Study (up to 26 weeks after last dose) |
Inclusion Criteria:
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.
Exclusion Criteria:
1. Participant with the evidence of COVID-19 infection at screening because of one or more of the following:
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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| Name | Affiliation | Role |
|---|---|---|
| Mark Bloch, A/Prof | Holdsworth House | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holdsworth House | Sydney | New South Wales | 2010 | Australia |
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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 |
|
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
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