This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore theImmunogenicity of EG-COVII in Healthy Adult Volunteers
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).
Biological: EG-COVII
EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and
Omicron variants
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;
Nucleus Network Pty Ltd- Melbourne
Melbourne 2158177, Victoria 2145234, Australia
Christina Chang, Dr., Principal Investigator
Nucleus Network Pty Ltd- Melbourne