A Phase 4 interventional study of 10μg R21/50μg Matrix-M and 5μg R21/50μg Matrix-M with adaptor preservative free in Plasmodium Falciparum Malaria, Malaria and Vaccine Reaction, sponsored by University of Oxford. Not yet recruiting at 2 sites in Bangladesh. Open to participants aged 14 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University of Oxford · Phase 4, Interventional, and Prevention
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:
Clinical procedure for participants:
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)
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 375 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults and adolescents receiving the standard adult vaccine dose
Biological: 10μg R21/50μg Matrix-M
Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125)
Biological: 5μg R21/50μg Matrix-M with adaptor preservative free
Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125)
Biological: 5μg R21/50μg Matrix-M with 2PE preservative
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
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)
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)
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)
Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen
Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M
Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12
Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative.
Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12
Prevalence and level of vaccine-induced antibodies.
Time frame: At Month 0, Month 3, Month 11 and Month 12
Prevalence and level of immunity to malaria and immunological responsiveness that may be relevant to prior malaria exposure and be used to predict vaccine immunogenicity.
Time frame: At Month 0, Month 3, Month 11 and Month 12
Prevalence and level of other factors affecting vaccine immunogenicity, such as antibodies against viral pathogens including cytomegalovirus.
Time frame: At Month 0, Month 3, Month 11 and Month 12
Plan to share: Yes — With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy (https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs)with data repositories such as the WorldWide Antimalarial Resistance Network (WWARN, terms of submission here: http://www.wwarn.org/tools-resources/terms-submission) or other researchers to use in the future. All personal information will be anonymised so that no individual can be identified from their treatment records, through interviews, or from mapping data.
Supporting information: Informed consent form, Clinical study report
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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