A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
NCT ID: NCT06958198
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
56 participants
INTERVENTIONAL
2025-09-15
2026-10-31
Brief Summary
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Detailed Description
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Groups 1 to 4 and 6 will be recruited in a staggered process. There will be a DSMB review prior to age deescalation. There will also be three sentinel participants per group and DSMB reviews prior to each subsequent (second and third) vaccination. Group 5 can be recruited at any time and without need for sentinel participants or DSMB review.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Follow-up will be for 6 months post third vaccination.
PREVENTION
NONE
Study Groups
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Group 1(n=8) adults (18-35years)
They will receive three doses of 5 µg R21 + 10 µg RH5.1 + 10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1
A soluble protein vaccine against the RH5 antigen
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Group 2 (n=8) Children aged between 5-17months
They will receive three doses of 5 µg R21 + 10 µg RH5.1, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1
A soluble protein vaccine against the RH5 antigen
Matrix-M™
A saponin-based vaccine adjuvant
Group 3 (n=8) children aged between 5-17 months
They will receive three doses of 5 µg R21 + 10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Group 4 (n=8) Children aged between 5-17 months
They will receive three doses of 5 µg R21 + 10 µg RH5.1 +10 µg R78C , administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1
A soluble protein vaccine against the RH5 antigen
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Group 5 (n=8) children aged 5-17 months
They will receive three doses of 5 µg R21, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
Matrix-M™
A saponin-based vaccine adjuvant
Group 6 ( n=16) Children 5-17 months
They will receive three doses of 10 µg RH5.1 +10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
RH5.1
A soluble protein vaccine against the RH5 antigen
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Interventions
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R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1
A soluble protein vaccine against the RH5 antigen
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
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.
5 Months
35 Years
ALL
Yes
Sponsors
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Institut de Recherche en Sciences de la Sante, Burkina Faso
OTHER_GOV
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Wellcome Trust
OTHER
European Vaccine Initiative
OTHER
Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)
UNKNOWN
University of Oxford
OTHER
Responsible Party
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Locations
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Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso
Countries
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Central Contacts
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Angela Minassian, Honorary Consultant and CI
Role: CONTACT
Facility Contacts
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Dr Athanase M. Somé, Doctorat en médecine
Role: primary
Other Identifiers
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VAC093
Identifier Type: -
Identifier Source: org_study_id