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ClinicalTrials.gov ID

NCT07194668

Lead Sponsor

University of OxfordOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

375Estimated

Last Update Posted

Aug 4, 2026Actual

Start Date

Aug 15, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

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

Brief 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.

• Plasmodium Falciparum Malaria
• Malaria
• Vaccine Reaction

• 10μg R21/50μg Matrix-M
• 5μg R21/50μg Matrix-M with adaptor preservative free
• 5μg R21/50μg Matrix-M with 2PE preservative

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Residence in a study village for the study period, i.e. 12 months.
• Age 14 years to 60 years.
• Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).

Exclusion Criteria:

• Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
• Acute illness requiring intervention.
• A history of an adverse reaction to study vaccine.
• Prior receipt of any other malaria vaccine.
• Enrolment in another intervention trial in the last month.
• Planned enrolment in another intervention trial in the coming 12 months.
• Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of OxfordOTHER

drmafaiz@gmail.com+008801613008857