Status:
COMPLETED
Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults
Lead Sponsor:
EuBiologics Co.,Ltd
Conditions:
COVID-19
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04783311
Start Date
February 23 2021
End Date
September 27 2022
Last Update
May 19 2023
Active Locations (1)
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1
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, South Korea