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Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers

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Trial Profile

Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Jan 2023

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At a glance

  • Drugs COVID-2019 vaccine-ImmunityBio (Primary) ; COVID-2019 vaccine-ImmunityBio (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors ImmunityBio
  • Most Recent Events

    • 19 Jul 2021 Status changed from recruiting to active, no longer recruiting.
    • 15 Mar 2021 According to an ImmunityBio media release, six participants have been dosed in each trial (NCT04591717 and NCT04732468) to date. Based on the findings of these trials, the optimal combination of administration route and dose will be determined and entered into the Phase II/III design.
    • 15 Mar 2021 According to an ImmunityBio media release, two phase Ib trials (n=12, NCT04591717 and NCT04732468) has met the safety requirements for the first 12 participants.The independent Safety Review Committee recommended the study to continue with no modifications to the trial design. The trials, which will involve 80 participants, are expected to be fully enrolled in Q2 (prime plus boost).
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