COVID-19
Conditions
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
Interventions
BIOLOGICALEuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
OTHERNormal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Sponsors
EuBiologics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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) 2. Individuals who are available for all visit procedures including telephone visits during the study period
Exclusion criteria
1. COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive 2. History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection 3. History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2 4. Immune system disorders including immunodeficiency disease 5. Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator 6. Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals 7. Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study 8. History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components 9. History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening 10. 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 11. Pregnant or breastfeeding woman 12. Treatment with other IPs within 6 months prior to participation in this study 13. Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAEs | within 52 weeks after the last IP dosing |
| AESIs | within 52 weeks after the last IP dosing |
| Solicited local and systemic AEs | for 7 days after each IP dosing |
| Unsolicited AEs | within 28 days after the last IP dosing |
| Immediate AEs | within 30 minutes after each IP dosing |
Countries
South Korea
Outcome results
None listed