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A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )

Study acronym: MIST3
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Start date: Dec 1, 2025 to Jan 1, 2027v10
  2. Notable Primary and study completion dates: Dec 30, 2025 to Dec 30, 2027
    • Start date: Dec 1, 2024 to Dec 1, 2025
    v9
  3. Notable Primary completion date: May 2024 to Dec 30, 2025
    • Start date: Feb 2024 to Dec 1, 2024
    • Study completion date: May 30, 2024 to Dec 30, 2025
    v8
  4. Notable Start date: Sep 2023 to Feb 2024v7
  5. Minor Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Mar 2023 to Sep 2023
    • Primary completion date: May 30, 2024 to May 2024
    v5
  2. Minor Eligibility criteria shortened, about 100 wordsv4
  3. Minor Study title shortened, about 2 wordsv3
  4. Notable Start date: Sep 20, 2022 to Mar 2023v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 project is the third part of a 5-year research program entitled "Malaria Infection Studies in Thailand (MIST)" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII/Matrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII/Matrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII/Matrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form. This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A
Trial Details
NCT Number NCT05380388
Lead Sponsor University of Oxford
Collaborators: Mahidol University
Conditions
(from sponsor)
Plasmodium Vivax Infection, Malaria Vaccine
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov