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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06099613

Enrollment

Registered

2023-10-25

Start date

2023-11-30

Completion date

2025-02-28

Last updated

2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Detailed 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).

Interventions

BIOLOGICALEG-COVII

EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of EG-COVII in healthy adult volunteers	7 weeks follow up	Number of participants with adverse events (AEs) Number of participants with abnormal clinical laboratory results (hematology /chemistry /urinalysis) Number of participants with abnormal vital sign Number of participants with abnormal physical examination results

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026