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InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

Study acronym: SUNSHINE
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 7, 2024 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2024 to May 2025 · Start date changed from estimate of Nov 2023 to Oct 10, 2024 · Completion date: Dec 2024 to May 2025 · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Oct 2024 to May 2025
    • Start date changed from estimate of Nov 2023 to Oct 10, 2024
    • Completion date: Dec 2024 to May 2025
    • Eligibility criteria expanded, about 23 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Oct 2023 to Nov 2023v3
  3. Interventions: 10 μg InvaplexAR-Detox (Biological), 10 μg InvaplexAR-Detox with 0.1 μg of dmLT (Biological), 2.5 μg InvaplexAR-Detox (Biological), 2.5 μg… to 0.1 μg of dmLT (Biological), 10 μg InvaplexAR-Detox (Biological), 2.5 μg InvaplexAR-Detox (Biological), Placebo (Biological) Study arms: 9 to 5v2 Show 1 more changeShow less
    • Study arms: 9 to 5
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants. The main questions it aims to answer are: * Is the new Shigella vaccine (with and without the new adjuvant) safe and well tolerated? * How wel does the new Shigella vaccine stimulate the immune system in combination with the new adjuvant, and without the new adjuvant? Participants will receive three vaccinations at 28-day intervals. Researchers will compare the results of participants vaccinated with the vaccine in combination with the adjuvant to the results of participants vaccinated with the vaccine only and to the results of participants vaccinated with a placebo (fake vaccine).
Trial Details
NCT Number NCT05961059
Lead Sponsor Leiden University Medical Center
Collaborators: Centre for Infectious Disease Research in Zambia, PATH, Walter Reed Army Institute of Research (WRAIR), Göteborg University, European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions Shigellosis, Bacillary Dysentery
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov