NCT07194668

R21/MM Dosing, Presentations, and Preservatives

Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study was funded by Hanako Foundation. The grant reference number: 001/2026.

Conditions

• Plasmodium Falciparum Malaria
• Malaria
• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	10μg R21/50μg Matrix-M	Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
BIOLOGICAL	5μg R21/50μg Matrix-M with adaptor preservative free	Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)
BIOLOGICAL	5μg R21/50μg Matrix-M with 2PE preservative	Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-09-26
• Last updated: 2026-03-16

Locations

2 sites across 1 country: Bangladesh