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

PHASE1PHASE2RECRUITING

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

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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;

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-10-23

Primary completion: 2024-04-01

Study completion finish: 2024-07-01

Study type

PREVENTION

Phase

PHASE1

PHASE2

Trial ID

NCT06099613

Intervention or treatment

BIOLOGICAL: EG-COVII

Conditions

• COVID-19

Condition: COVID-19
BIOLOGICAL: EG-COVII
Melbourne, Victoria, Australia
Sponsor: EyeGene Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network Pty Ltd- Melbourne

Research sites nearby

Select from list below to view details:

Nucleus Network Pty Ltd- Melbourne
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EG-COVII Not Specified	BIOLOGICAL: EG-COVII EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Safety and tolerability of EG-COVII in healthy adult volunteers	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	7 weeks follow up

Secondary outcome

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult