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

Phase 1

Completed

• Conditions: COVID-19

• Registration Number: NCT04783311
• Lead Sponsor: EuBiologics Co.,Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-23
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Primary Completion: 2021-10-15
• Study Completion: 2022-09-27
• Status Verified: 2022-12
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SAEs	within 52 weeks after the last IP dosing
Unsolicited AEs	within 28 days after the last IP dosing
Solicited local and systemic AEs	for 7 days after each IP dosing
AESIs	within 52 weeks after the last IP dosing
Immediate AEs	within 30 minutes after each IP dosing

Trial Locations

Locations (1)

The Catholic University of Eunpyeong St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of