Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06099613




Registration number
NCT06099613
Ethics application status
Date submitted
23/10/2023
Date registered
25/10/2023
Date last updated
26/10/2023

Titles & IDs
Public title
Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult
Scientific title
A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
Secondary ID [1] 0 0
EG-COVID-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - EG-COVII

Experimental: EG-COVII -


Other interventions: EG-COVII
EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of EG-COVII in healthy adult volunteers
Timepoint [1] 0 0
7 weeks follow up

Eligibility
Key inclusion criteria
- Able to understand and comply with the study procedures, understand the risks involved
in the study, and provide written informed consent before the first study-specific
procedure;

- Healthy volunteers aged above 18 years at the time of screening;

- Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of
booster;

- The last authorised COVID-19 vaccination, the participants received, should be more
than 16 weeks prior to the first IP vaccination;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant with the evidence of COVID-19 infection at screening (Positive for
COVID-19 with RT-PCR test with nasal mid-turbinate specimen);

- Participant who has the history of COVID-19 infection within 6 months from the first
IP vaccination;

- Close contact with a person infected with COVID-19 within 2 weeks prior to the first
IP vaccination;

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd- Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
EyeGene Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity
of EG-COVII in Healthy Adult Volunteers
Trial website
https://clinicaltrials.gov/ct2/show/NCT06099613
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Chang, Dr.
Address 0 0
Nucleus Network Pty Ltd- Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daeun Kim
Address 0 0
Country 0 0
Phone 0 0
+8223221687
Fax 0 0
Email 0 0
aliceblue@eyegene.co.kr
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06099613