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OpenTrials
Completed

NCT Number: NCT06099613

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nucleus Network Pty Ltd- Melbourne

Melbourne, Victoria, 3004, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

EG-COVII

Biological

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

Primary outcomes

  1. Safety and tolerability of EG-COVII in healthy adult volunteers

    Time frame: 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

Sponsors and collaborators

Lead sponsor

EyeGene Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 25, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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