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

    Study type

    PREVENTION

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06099613

    Intervention or treatment

    BIOLOGICAL: EG-COVII

    Conditions

    • COVID-19

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety and tolerability of EG-COVII in healthy adult volunteersNumber 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 results7 weeks follow up

    Secondary outcome

    Frequently Asked Questions

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    References

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

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