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Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 6, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Oct 30, 2025 to Jun 30, 2026
    • Start date: Oct 1, 2024 to Jun 1, 2025
    v5
  2. Primary and study completion dates: Apr 30, 2024 to Oct 30, 2025
    • Start date: Feb 1, 2024 to Oct 1, 2024
    v4
  3. Start date: Oct 1, 2023 to Feb 1, 2024v3
  4. Primary and study completion dates: Apr 30, 2023 to Apr 30, 2024
    • Start date: Oct 1, 2022 to Oct 1, 2023
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single centre, randomized, placebo-controlled phase 1/2 study comparing two malaria vaccine candidates. The first vaccine candidate PfSPZ-CVac (Plasmodium falciparum sporozoites (PfSPZ) challenge administered with a chemoprophylactic antimalarial) will be chemoattenuated in vivo with the antimalarial Pyramax. The second vaccine candidate is prime- target vaccination with viral vectored vaccine candidate regime MVA ME-TRAP (Modified Vaccinia Ankara (MVA) multiple epitope thrombosponin-related adhesion protein (ME-TRAP)) and ChAd63 ME-TRAP (Chimpanzee adenovirus 63 (ChAd63). The safety and protective efficacy of both vaccine candidates will be to assessed by controlled human malaria infection with PfSPZ Challenge strain NF54 administered intravenously by syringe.
Trial Details
NCT Number NCT05441410
Lead Sponsor University Hospital Tuebingen
Collaborators: Sanaria Inc., University of Oxford
Conditions
(from sponsor)		 Malaria
Related terms Malaria
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov