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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

EuCorVac-19

Normal Saline

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)
Individuals who are available for all visit procedures including telephone visits during the study period

Exclusion Criteria:

COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
Immune system disorders including immunodeficiency disease
Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
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
Pregnant or breastfeeding woman
Treatment with other IPs within 6 months prior to participation in this study
Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Sites / Locations

The Catholic University of Eunpyeong St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Phase 1 - EuCorVac-19 Low dose group

Phase 1 - EuCorVac-19 High dose group

Phase 2 - EuCorVac-19 Low dose group

Phase 2 - EuCorVac-19 High dose group

Phase 2 - Placebo comparator group

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Outcomes

Primary Outcome Measures

Immediate AEs

Solicited local and systemic AEs

Unsolicited AEs

SAEs

AESIs

Secondary Outcome Measures

Full Information

NCT ID

NCT04783311

First Posted

March 3, 2021

Last Updated

May 17, 2023

Sponsor

EuBiologics Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04783311

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

February 23, 2021 (Actual)

Primary Completion Date

October 15, 2021 (Actual)

Study Completion Date

September 27, 2022 (Actual)

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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 - EuCorVac-19 Low dose group

Arm Type

Experimental

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Arm Title

Phase 1 - EuCorVac-19 High dose group

Arm Type

Experimental

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Arm Title

Phase 2 - EuCorVac-19 Low dose group

Arm Type

Experimental

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Arm Title

Phase 2 - EuCorVac-19 High dose group

Arm Type

Experimental

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Arm Title

Phase 2 - Placebo comparator group

Arm Type

Active Comparator

Arm Description

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Intervention Type

Biological

Intervention Name(s)

EuCorVac-19

Intervention Description

Two intramuscular doses (0.5mL per dose) at 3-week interval

Intervention Type

Other

Intervention Name(s)

Normal Saline

Intervention Description

Two intramuscular doses (0.5mL per dose) at 3-week interval

Primary Outcome Measure Information:

Title

Immediate AEs

Time Frame

within 30 minutes after each IP dosing

Title

Solicited local and systemic AEs

Time Frame

for 7 days after each IP dosing

Title

Unsolicited AEs

Time Frame

within 28 days after the last IP dosing

Title

SAEs

Time Frame

within 52 weeks after the last IP dosing

Title

AESIs

Time Frame

within 52 weeks after the last IP dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Individuals who are available for all visit procedures including telephone visits during the study period Exclusion Criteria: COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2 Immune system disorders including immunodeficiency disease Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening 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 Pregnant or breastfeeding woman Treatment with other IPs within 6 months prior to participation in this study Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Facility Information:

Facility Name

The Catholic University of Eunpyeong St.Mary's Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

34050027

Citation

Sia ZR, He X, Zhang A, Ang JC, Shao S, Seffouh A, Huang WC, D'Agostino MR, Teimouri Dereshgi A, Suryaprakash S, Ortega J, Andersen H, Miller MS, Davidson BA, Lovell JF. A liposome-displayed hemagglutinin vaccine platform protects mice and ferrets from heterologous influenza virus challenge. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2025759118. doi: 10.1073/pnas.2025759118.

Results Reference

derived

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

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