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A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adult

Status Approved

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006670
Unique Protocol ID	2021-1133
Public/Brief Title	A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adult
Scientific Title	A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adult
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2021-1133
Approval Date	2021-07-30
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sung-Han Kim
Title	M.D., Ph.D.
Telephone	+82-2-3010-4670
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Public Queries
Name	Sung-Han Kim
Title	M.D., Ph.D.
Telephone	+82-2-3010-4670
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Updating Information
Name	Hanna An
Title	Assistant manager
Telephone	+82-70-5080-0285
Affiliation	Eyegene
Address	B-910, 401 Yangcheon-ro, Gangseo-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-09-14 Actual
Target Number of Participant	45
Primary Completion Date	2021-12-02 , Anticipated
Study Completion Date	2022-12-30 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-09-14 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Eyegene
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Eyegene
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
Lay Summary	To assess safety and tolerability of EG-COVID in healthy adult after first and second vaccinations

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Phase1/Phase2
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Biological/Vaccine, /Non-Stem Cell
Intervention Description	Low-dose group: EG-COVID 0.25mL(mRNA 50 μg) Mid-dose group: EG-COVID 0.50mL(mRNA 100 μg) High-dose group: EG-COVID 0.50mL(mRNA 200 μg)
Number of Arms	3
Arm 1	Arm Label Low-dose group: EG-COVID 0.25mL(mRNA 50 μg)
	Target Number of Participant 15
	Arm Type Experimental
	Arm Description Two single IM injection will be given 21 days apart
Arm 2	Arm Label Mid-dose group: EG-COVID 0.50mL(mRNA 100 μg)
	Target Number of Participant 15
	Arm Type Experimental
	Arm Description Two single IM injection will be given 21 days apart
Arm 3	Arm Label High-dose group: EG-COVID 0.50mL(mRNA 200 μg)
	Target Number of Participant 15
	Arm Type Experimental
	Arm Description Two single IM injection will be given 21 days apart

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (A00-B99)Certain infectious and parasitic diseases (B34.2)Coronavirus infection, unspecified site Prevention of SARS-CoV-2-mediated COVID-19 infection
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~54Year
	Description 1. provide written informed consent before the first study-specific procedure - 19~54 years, Male and Female (Step 1 (Phase I)) - 19~85 years, Male and Female (Step 2 (Phase IIa)) 2. Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening 3. Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion 4. Must agree not to donate blood or transfusion (including whole blood, plasma, and platelet components)
Exclusion Criteria	1. Participant with the evidence of COVID-19 infection because of one or more of the following: 1) Positive for COVID-19 when performing RT-PCR with upper respiratory tract samples; (oropharyngeal/nasopharyngeal swab) (However, if symptoms of cough or sputum are present, additional RT-PCR is performed using a lower respiratory tract sample (sputum), and registration is possible if all are negative) 2) History of COVID-19; 3) Positive test for COVID-19 (lgM or IgG) antibody at screening;
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Solicited Adverse Events recorded up to 1st and 2nd vaccination
Timepoint	Visit 2(D0), Visit 3(D7), Visit 4(D14), Visit 5(D21), Visit 6(D28)
Primary Outcome(s) 2
Outcome	SRR, GMT, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
Timepoint	Visit 2(D0), Visit 4(D14), Visit 5(D21), Visit 6(D28), Visit 7(D49), Visit 8(D189), Visit 9(D386)
Secondary Outcome(s) 1
Outcome	T cell response ratio in ICS assay from before vaccination to each subsequent time point
Timepoint	Visit 2(D0), Visit 4(D14), Visit 6(D28), Visit 7(D49), Visit 8(D189), Visit 9(D386)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No