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

Sponsor
EuBiologics Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05603052
Collaborator
(none)
4,000
Enrollment
1
Location
4
Arms
14.7
Anticipated Duration (Months)
272.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: EuCorVac-19
  • Biological: ChAdOx1
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 11, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test group(EuCorVac-19) - Cohort A

Cohort A - Immunogenicity cohort

Biological: EuCorVac-19
COVID-19 vaccine
Active Comparator: Comparator group(ChAdOx1) - Cohort A

Cohort A - Immunogenicity cohort

Biological: ChAdOx1
COVID-19 vaccine
Experimental: Test group(EuCorVac-19) - Cohort B

Cohort B - Safety cohort

Biological: EuCorVac-19
COVID-19 vaccine
Active Comparator: Comparator group(ChAdOx1) - Cohort B

Cohort B - Safety cohort

Biological: ChAdOx1
COVID-19 vaccine

Outcome Measures

Primary Outcome Measures

  1. The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 [14 days after the 2nd vaccination]

  2. The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1 [14 days after the 2nd vaccination]

Secondary Outcome Measures

  1. Occurrence of solicited Adverse Events (AEs) [Through 7 days after each vaccination]

  2. Occurrence of unsolicited Adverse Events (AEs) [Through 28 days after the 2nd vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trial site Kinshasa Congo, The Democratic Republic of the

Sponsors and Collaborators

  • EuBiologics Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05603052
Other Study ID Numbers:
  • EuSNAP_COV302
First Posted:
Nov 2, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Nov 2, 2022