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

• ClinicalTrials.gov Identifier: NCT05572879
• Recruitment Status: Active, not recruiting
• First Posted: October 10, 2022
• Last Update Posted: December 1, 2023
• Sponsor: EuBiologics Co.,Ltd
• Information provided by (Responsible Party): EuBiologics Co.,Ltd

Tracking Information

• First Submitted Date: October 6, 2022
• First Posted Date: October 10, 2022
• Last Update Posted Date: December 1, 2023
• Actual Study Start Date: October 1, 2022
• Actual Primary Completion Date: June 23, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2022)

• The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 [ Time Frame: 14 days after the 2nd vaccination ]
• The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1 [ Time Frame: 14 days after the 2nd vaccination ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 6, 2022)

• Occurrence of solicited Adverse Events (AEs) [ Time Frame: Through 7 days after each vaccination ]
• Occurrence of unsolicited Adverse Events (AEs) [ Time Frame: Through 28 days after the 2nd vaccination ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: EuCorVac-19
  COVID-19 vaccine
• Biological: ChAdOx1 nCoV-19
  COVID-19 vaccine
  Other Name: COVISHIELD

Study Arms

• Experimental: Test group(EuCorVac-19) - Cohort A
  Cohort A - Immunogenicity cohort
  Intervention: Biological: EuCorVac-19
• Active Comparator: Comparator group(ChAdOx1) - Cohort A
  Cohort A - Immunogenicity cohort
  Intervention: Biological: ChAdOx1 nCoV-19
• Experimental: Test group(EuCorVac-19) - Cohort B
  Cohort B - Safety cohort
  Intervention: Biological: EuCorVac-19
• Active Comparator: Comparator group(ChAdOx1) - Cohort B
  Cohort B - Safety cohort
  Intervention: Biological: ChAdOx1 nCoV-19

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 30, 2023): 2600
• Original Estimated Enrollment (submitted: October 6, 2022): 4000
• Estimated Study Completion Date: May 31, 2024
• Actual Primary Completion Date: June 23, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Philippines

Administrative Information

• NCT Number: NCT05572879
• Other Study ID Numbers: EuSNAP_COV301
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: EuBiologics Co.,Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: EuBiologics Co.,Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: EuBiologics Co.,Ltd
• Verification Date: November 2023