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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)

A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine) (NCT06958198) is a Phase 1 interventional studying Malaria,Falciparum, sponsored by University of Oxford. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Malaria,Falciparum, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 56 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Malaria,Falciparum subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Only participants who meet all the inclusion criteria will be enrolled into the trial: - Group 1: Healthy adult aged 18-35 years at the time of first study vaccination - Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination - Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy . test), and practice continuous effective contraception until three months after the final study vaccination - Participant or parent/guardian provides signed/thumb-printed willing to sign a consent form - Participant (and parent/guardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up - Who Should NOT Join This Trial: - The participant may not enter the trial if ANY of the following apply: - Clinically significant congenital abnormalities as judged by the PI or other delegated individual. - Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual. - History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). - Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition. - History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. - Sickle cell disease. - Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual. - Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Only participants who meet all the inclusion criteria will be enrolled into the trial: * Group 1: Healthy adult aged 18-35 years at the time of first study vaccination * Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination * Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy . test), and practice continuous effective contraception until three months after the final study vaccination * Participant or parent/guardian provides signed/thumb-printed informed consent * Participant (and parent/guardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up - Exclusion Criteria: * The participant may not enter the trial if ANY of the following apply: * Clinically significant congenital abnormalities as judged by the PI or other delegated individual. * Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual. * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). * Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition. * History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Sickle cell disease. * Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual. * Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. * Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 28 days following each study vaccination. * History of vaccination with any malaria vaccine. * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. * Suspected or known current alcohol misuse. * Suspected or known injecting drug use in the 5 years preceding enrolment. * Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. * Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For children, any history of vertical exposure to HIV infection. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day; inhaled and topical steroids are allowed). * Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Vaccination and re-vaccination exclusion criteria: The following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event: * Anaphylactic reaction following administration of vaccine. * Pregnancy. The following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator. The participant must be followed until resolution of the event as with any adverse event: * Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature \< 37.5°C. * Temperature of \>37.5°C (99.5°F) at the time of vaccination.

Treatments Being Tested

BIOLOGICAL

R21

A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein

BIOLOGICAL

RH5.1

A soluble protein vaccine against the RH5 antigen

BIOLOGICAL

R78C

A soluble RIPR EGF-CyRPA fusion protein vaccine

BIOLOGICAL

Matrix-M™

A saponin-based vaccine adjuvant

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06958198), the sponsor (University of Oxford), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06958198 clinical trial studying?

This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06958198?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06958198?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06958198. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06958198. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.