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A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 15, 2026 Primary endpoints: 6 to 5 · Eligibility criteria expanded, about 35 words · Site details revised at 2 of 9 sites · 2 more Show 5 more changesShow less
    • Primary endpoints: 6 to 5
    • Eligibility criteria expanded, about 35 words
    • Site details revised at 2 of 9 sites
    • Publications: details revised at 2 of 2 entries
    • Study description shortened, about 1 word
  2. Trial status: Active, Not Recruiting to Completed Study sites: 8 to 9 · Study completion date changed from estimate of Mar 2026 to Mar 4, 2026v13 Show 2 more changesShow less
    • Study sites: 8 to 9
    • Study completion date changed from estimate of Mar 2026 to Mar 4, 2026
  3. Primary completion date changed from estimate of Sep 2025 to Aug 25, 2025v12
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 9 to 8v11 Show 1 more changeShow less
    • Study sites: 9 to 8
  5. Phase: Phase 1 to Phase 1/2 Trial status: Active, Not Recruiting to Recruiting · Enrollment target: 64 to 96 · Primary endpoints revised (6) · 4 morev10 Show 7 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 64 to 96
    • Primary endpoints revised (6)
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 107 words
    • Study description expanded, about 61 words
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Oct 2024 to Sep 2025 Trial status: Recruiting to Active, Not Recruiting · Study sites: 9 to 8 · Completion date: May 2025 to Mar 2026v9 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 9 to 8
    • Completion date: May 2025 to Mar 2026
  2. Re-verified, no change to tracked fieldsv8
  3. Site details revised at 1 of 9 sitesv7
  4. Enrollment target: 96 to 64 Primary endpoints revised (6) · Study sites: 8 to 9 · Primary completion date: May 2024 to Oct 2024 · 5 morev6 Show 8 more changesShow less
    • Primary endpoints revised (6)
    • Study sites: 8 to 9
    • Primary completion date: May 2024 to Oct 2024
    • Completion date: Dec 2024 to May 2025
    • Interventions: BNT166a (Biological), BNT166c (Biological) to BNT166a (Biological)
    • Eligibility criteria revised
    • Study description shortened, about 54 words
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 5 to 8v5
  6. Study sites: 2 to 5v4
  7. Study sites: 1 to 2v3
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 2023 to Sep 21, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2023 to Sep 21, 2023
  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.
BioNTech SE
49 trials monitored
See 3 trials at risk
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This study was originally planned to include four substudies, i.e., substudy A (SSA), substudy B (SSB), substudy C (SSC), and substudy D (SSD). Sponsor decided not to conduct SSC, thus three substudies (SSA, SSB, and SSD) were conducted. In SSA and SSB, dosing started with an initial sentinel group, followed by the expansion cohort. In SSD, dosing was initiated after the interim analysis of SSA and SSB 1-month post-Dose 2 safety, reactogenicity, and immunogenicity data was received. This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.
Trial Details
NCT Number NCT05988203
Lead Sponsor BioNTech SE
Conditions Monkeypox
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov