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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783311
• Other study ID #: EuSNAP_COV101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 23, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: December 2022
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: September 27, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval

Other:
• Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Eunpyeong St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate AEs		within 30 minutes after each IP dosing
Primary	Solicited local and systemic AEs		for 7 days after each IP dosing
Primary	Unsolicited AEs		within 28 days after the last IP dosing
Primary	SAEs		within 52 weeks after the last IP dosing
Primary	AESIs		within 52 weeks after the last IP dosing