Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult

EyeGene

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Biological: EG-COVII

Study type

Interventional

Funder types

Other

Identifiers

NCT06099613

EG-COVID-103

Details and patient eligibility

About

This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

Full description

Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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;

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;