Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




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

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
Treatment: Other - EG-COVII

Experimental: EG-COVII -


Treatment: Other: 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
Treatment: Other
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
NA
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
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06099613