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A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
EuCorVac-19
ChAdOx1 nCoV-19
Sponsored by
EuBiologics Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Trial siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Test group(EuCorVac-19) - Cohort A

Comparator group(ChAdOx1) - Cohort A

Test group(EuCorVac-19) - Cohort B

Comparator group(ChAdOx1) - Cohort B

Arm Description

Cohort A - Immunogenicity cohort

Cohort A - Immunogenicity cohort

Cohort B - Safety cohort

Cohort B - Safety cohort

Outcomes

Primary Outcome Measures

The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1

Secondary Outcome Measures

Occurrence of solicited Adverse Events (AEs)
Occurrence of unsolicited Adverse Events (AEs)

Full Information

First Posted
November 1, 2022
Last Updated
July 20, 2023
Sponsor
EuBiologics Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05603052
Brief Title
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
Official Title
A Phase III, Randomized, Observer-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Immunogenicity and Safety of a Preventive COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuBiologics Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group(EuCorVac-19) - Cohort A
Arm Type
Experimental
Arm Description
Cohort A - Immunogenicity cohort
Arm Title
Comparator group(ChAdOx1) - Cohort A
Arm Type
Active Comparator
Arm Description
Cohort A - Immunogenicity cohort
Arm Title
Test group(EuCorVac-19) - Cohort B
Arm Type
Experimental
Arm Description
Cohort B - Safety cohort
Arm Title
Comparator group(ChAdOx1) - Cohort B
Arm Type
Active Comparator
Arm Description
Cohort B - Safety cohort
Intervention Type
Biological
Intervention Name(s)
EuCorVac-19
Intervention Description
COVID-19 vaccine
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 nCoV-19
Other Intervention Name(s)
COVISHIELD
Intervention Description
COVID-19 vaccine
Primary Outcome Measure Information:
Title
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Time Frame
14 days after the 2nd vaccination
Title
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
Time Frame
14 days after the 2nd vaccination
Secondary Outcome Measure Information:
Title
Occurrence of solicited Adverse Events (AEs)
Time Frame
Through 7 days after each vaccination
Title
Occurrence of unsolicited Adverse Events (AEs)
Time Frame
Through 28 days after the 2nd vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Collin Choi
Phone
+82-2-572-6675
Email
collin.choi@eubiologics.com
Facility Information:
Facility Name
Trial site
City
Kinshasa
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

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