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R21/MM Dosing, Presentations, and Preservatives

Study acronym: VAC100
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Apr 1, 2026 to Aug 15, 2026
    • Site details revised at 1 of 2 sites
    v5
  2. Start date: Mar 1, 2026 to Apr 1, 2026
    • Study description expanded, about 12 words
    v4
  3. Start date: Dec 1, 2025 to Mar 1, 2026v3
  4. Start date: Oct 1, 2025 to Dec 1, 2025
    • Site details revised at 1 of 2 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. All participants will receive the same number of injections and will be randomly assigned to receive one of the followings: * Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125). * Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125) * Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125) Clinical procedure for participants: * Standardized symptom questionnaire * Physical examination: Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential) * Venous blood collection (Pre-vaccination) 3mL * Vaccination
Trial Details
NCT Number NCT07194668
Lead Sponsor University of Oxford
Conditions
(from sponsor)		 Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction
Related terms Malaria, Malaria, Falciparum
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov