A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Biological: EuCorVac-19; Biological: ChAdOx1 nCoV-19

• Registration Number: NCT05572879
• Lead Sponsor: EuBiologics Co.,Ltd

Brief Summary

This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Primary Completion: 2023-06-23
• Status Verified: 2023-11
• Study Completion: 2024-02-09
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

• Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent
• Female of childbearing potential who agree to use medically allowed methods of contraception during the study period
• Individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion Criteria

• Individual being considered to be confirmed COVID-19
• Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP
• Individuals at high risk of exposure to SARS-CoV-2
• Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening
• Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease
• Individuals with serious medical or psychiatric disease
• History of SARS-CoV or MERS-CoV infection
• History of allergic reaction or hypersensitivity reactions to any of components of the IP
• History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination
• History of receiving organ or bone marrow transplant
• Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination
• History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
• History of vaccination with test vaccine substance
• Treatment with immunosuppressants or immune modifying drugs
• History of treatment with antipsychotics or opioid dependence
• Pregnant or lactating women
• Other 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

Arm && Interventions

Group	Intervention	Description
Test group(EuCorVac-19) - Cohort B	EuCorVac-19	Cohort B - Safety cohort
Test group(EuCorVac-19) - Cohort A	EuCorVac-19	Cohort A - Immunogenicity cohort
Comparator group(ChAdOx1) - Cohort A	ChAdOx1 nCoV-19	Cohort A - Immunogenicity cohort
Comparator group(ChAdOx1) - Cohort B	ChAdOx1 nCoV-19	Cohort B - Safety cohort

Primary Outcome Measures

Name	Time	Method
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1	14 days after the 2nd vaccination
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1	14 days after the 2nd vaccination

Secondary Outcome Measures

Name	Time	Method
Occurrence of solicited Adverse Events (AEs)	Through 7 days after each vaccination
Occurrence of unsolicited Adverse Events (AEs)	Through 28 days after the 2nd vaccination

Trial Locations

Locations (1)

Trial site; 🇵🇭 Manila, Philippines