New malaria vaccine dosing strategy tested in Early-Stage trial
NCT ID NCT06320535
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether giving the R21/Matrix-M malaria vaccine in a new, escalating-dose schedule is safe and creates a strong immune response. It involves 36 healthy adults in the UK who have never had malaria. The goal is to find a better way to protect people from this serious disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy adult aged 18 to 50 years. * Able and willing (in the Investigator's opinion) to comply with all study requirements. * Participants of childbearing potential only: must practice continuous effective contraception until the last study visit. * Agreement to refrain from blood donation for the duration of the study. * Able and willing to provide written informed consent to participate in the trial. Exclusion Criteria: * History of clinical malaria (any species) or previous participation in any malaria vaccine trial or controlled human malaria infection trial. * Travel to a clearly malaria endemic locality during the study period or within the preceding six months, as per the CDC website: https://www.cdc.gov/malaria/travelers/country\_table/a.html * Participation in another research study involving receipt of an investigational medicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of the investigational medicinal product, whichever is longer, or planned participation during the study period. * Prior receipt of an IMP likely to impact interpretation of the trial data, as assessed by the Investigator. * Receipt of any vaccine within 30 days of a study vaccine, with the exception of COVID-19 vaccination. * Receipt of oral or systemic immunosuppressant medication for more than 14 days in the six months preceding enrolment. * Receipt of immunoglobulins or blood products (e.g. blood transfusion) in the three months preceding enrolment. * History of anaphylaxis to vaccination, or allergy likely to be exacerbated by any component of the vaccine or study procedures, including allergy to lidocaine * Pregnancy, lactation or intention to become pregnant during the study. * Clinically significant history of chronic disease, including cancer (except basal cell carcinoma or cervical carcinoma in situ), immunodeficiency (including HIV), autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease), psychiatric disorder, drug or alcohol abuse * Positive Hepatitis B surface antigen (HBsAg), HIV antibodies or Hepatitis C (HCV) antibodies (except previous HCV vaccine study participants) * HEMStop score \> or = to 2(30) with abnormal coagulation screen or clinical concern regarding bleeding risk. * Use of medications that increase the risk of bleeding, as assessed by the clinician, including: warfarin, oral antithrombin agents (e.g. Apixaban), low molecular weight heparin * Any clinically significant abnormality of screening examination, blood or urine tests * Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data * Participants unable to be closely followed for social, geographic or psychological reasons. * Investigator inability to corroborate a participant's medical history via access to NHS electronic records and/or their GP.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, Oxfordshire, OX3 7LE, United Kingdom
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University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8HW, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New malaria drug interaction study launches in healthy volunteers
- New malaria shots could replace daily pills
- New malaria antibody enters first human safety tests
- Breastfeeding moms with malaria: do drugs reach baby?
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