A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
Primary Purpose
COVID-19
Status
Recruiting
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
EuCorVac-19
ChAdOx1 nCoV-19
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
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
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
1. Study Identification
Unique Protocol Identification Number
NCT05572879
Brief Title
A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
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
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
November 1, 2023 (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
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
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
YJ Lee
Phone
+82-2-572-6675
Email
yjlee@eubiologics.com
Facility Information:
Facility Name
Trial site
City
Manila
Country
Philippines
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
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