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R21/MM Dosing, Presentations, and Preservatives

NCT07194668 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2026-03-16

No results posted yet for this study

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

Conditions

  • Plasmodium Falciparum Malaria
  • Malaria
  • Vaccine Reaction

Interventions

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)

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194668 on ClinicalTrials.gov