Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults

May 17, 2023 updated by: EuBiologics Co.,Ltd

A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults

Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Eunpyeong St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals who voluntarily decide to participate in this study and provide written informed consent

    • Healthy male and female adult at the age of 19 to 50 years (Part A)
    • Healthy male and female adult at the age of 19 to 75 years (Part B)
  2. Individuals who are available for all visit procedures including telephone visits during the study period

Exclusion Criteria:

  1. COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
  2. History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
  3. History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
  4. Immune system disorders including immunodeficiency disease
  5. Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
  6. Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
  7. Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
  8. History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
  9. History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
  10. Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP
  11. Pregnant or breastfeeding woman
  12. Treatment with other IPs within 6 months prior to participation in this study
  13. Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Biological: EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Experimental: Phase 1 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Biological: EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval
Experimental: Phase 2 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Biological: EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Experimental: Phase 2 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Biological: EuCorVac-19
Two intramuscular doses (0.5mL per dose) at 3-week interval
Active Comparator: Phase 2 - Placebo comparator group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
Other: Normal Saline
Two intramuscular doses (0.5mL per dose) at 3-week interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immediate AEs
Time Frame: within 30 minutes after each IP dosing
within 30 minutes after each IP dosing
Solicited local and systemic AEs
Time Frame: for 7 days after each IP dosing
for 7 days after each IP dosing
Unsolicited AEs
Time Frame: within 28 days after the last IP dosing
within 28 days after the last IP dosing
SAEs
Time Frame: within 52 weeks after the last IP dosing
within 52 weeks after the last IP dosing
AESIs
Time Frame: within 52 weeks after the last IP dosing
within 52 weeks after the last IP dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuBiologics Co.,Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuSNAP_COV101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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