Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults

Study Overview
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Brief Summary
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Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults

Official Title
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A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults

Conditions
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COVID-19

Intervention / Treatment
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* Biological: EuCorVac-19
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who voluntarily decide to participate in this study and provide written informed consent Healthy male and female adult at the age of 19 to 50 years (Part A) Healthy male and female adult at the age of 19 to 75 years (Part B) Individuals who are available for all visit procedures including telephone visits during the study period Exclusion Criteria: COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2 Immune system disorders including immunodeficiency disease Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP Pregnant or breastfeeding woman Treatment with other IPs within 6 months prior to participation in this study Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 - EuCorVac-19 Low dose group<br>Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval | Biological: EuCorVac-19<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>Other: Normal Saline<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>|
| Experimental: Phase 1 - EuCorVac-19 High dose group<br>Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval | Biological: EuCorVac-19<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>Other: Normal Saline<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>|
| Experimental: Phase 2 - EuCorVac-19 Low dose group<br>Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval | Biological: EuCorVac-19<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>|
| Experimental: Phase 2 - EuCorVac-19 High dose group<br>Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval | Biological: EuCorVac-19<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>|
| Active Comparator: Phase 2 - Placebo comparator group<br>Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval | Other: Normal Saline<br>* Two intramuscular doses (0.5mL per dose) at 3-week interval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate AEs |  | within 30 minutes after each IP dosing | 
| Solicited local and systemic AEs |  | for 7 days after each IP dosing | 
| Unsolicited AEs |  | within 28 days after the last IP dosing | 
| SAEs |  | within 52 weeks after the last IP dosing | 
| AESIs |  | within 52 weeks after the last IP dosing |