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Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Primary and study completion dates: Jan 1, 2026 to Jan 1, 2027v12
  3. Primary completion date: May 1, 2025 to Jan 1, 2026
    • Start date: Jan 5, 2022 to Apr 5, 2022
    • Study completion date: Jul 1, 2025 to Jan 1, 2026
    v11
  4. Primary completion date: May 1, 2023 to May 1, 2025v10 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: May 5, 2023 to Jul 1, 2025
    • Interventions: JYNNEOS + TPOXX (Biological), JYNNEOS + TPOXX PLACEBO (Biological) to Placebo (Other), Smallpox and Mpox Vaccine (Drug), Tecovirimat (Drug)
    • Study title revised
    • Secondary endpoints shortened, about 5 words
  5. Study title expanded, about 2 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Active, Not Recruiting to Completedv8
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 1, 2022 to May 1, 2023
    • Site details revised at 2 of 2 sites
    v7
  3. Primary completion date: Jul 31, 2022 to Dec 1, 2022
    • Study completion date: Oct 31, 2022 to May 5, 2023
    v6
  4. Enrollment target: 445 to 100
    • Eligibility criteria shortened, about 189 words
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 28, 2022 to Jan 5, 2022
    v4
  6. Start date: Oct 21, 2021 to Feb 28, 2022
    • Primary completion date: May 31, 2022 to Jul 31, 2022
    • Study completion date: May 31, 2022 to Oct 31, 2022
    • Collaborators: 2 to 1
    v3
  7. Eligibility criteria expanded, about 7 words
    • Collaborators: 1 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.
Trial Details
NCT Number NCT04957485
Lead Sponsor SIGA Technologies
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Smallpox
Related terms Smallpox
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov