A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M
NCT ID: NCT07183371
Last Updated: 2025-12-18
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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NOT_YET_RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Detailed Description
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Follow up will be for six months following the last vaccination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
360 healthy children aged between 5 and 36 months at the time of first vaccination living in a malaria endemic area will be recruited at one site in Burkina Faso.
Participants will be randomised to receive either three doses of the malaria candidate vaccines R78C/Matrix-M and three doses of a commercially available rabies vaccine, three doses of RH5.1+R78C/Matrix-M and three doses of R21/Matrix-M or six doses of commercially available control vaccines.
Follow up will be for six months following the last vaccination.
PREVENTION
TRIPLE
The central study team will remain blinded. The laboratory team involved in the immunogenicity analysis will be blinded also.
The Local Safety Monitor (LSM) and Data Safety Monitoring Board (DSMB), will also be provided with the randomisation sequence. If deemed necessary for reasons such as safety, the LSM or DSMB will unblind the specific enrolled participant without revealing the study group to the investigators.
Study Groups
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Group 1 (n=120) children 5-36 months
They will receive three doses of 10 µg R78C + 50 µg Matrix-M, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182). A commercially available rabies vaccine, Rabivax-S, will be administered at Month 3 (Day 98), Month 4 (Day 126) and Month 5 (Day 154). All will be given as a intramuscular injections.
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
Rabivax-S
Rabivax-S is an inactivated, freeze-dried, single-dose vaccine. The vaccine contains purified, inactivated rabies antigen produced using Vero ATCC CCL 81 cells as the cell substrate, Pitman Moore (PM3218) as the virus strain, and sucrose, glycine and HSA (Human Serum Albumin) as excipients
Group 2 (n=120) children 5-36 months
They will receive three doses of 10 µg RH5.1 + 10 µg R78C + 50 µg Matrix-M, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182). 5 µg R21 + 50 µg Matrix-M will be administered at Month 3 (Day 98), Month 4 (Day 126) and Month 5 (Day 154), also given as Intramuscular injections. All will be given as intramuscular injections.
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 3 (n=120) children 5-36 months
Participants will receive six doses of commercially available control vaccines. This consists of the Hepatitis A vaccine, Avaxim 80, which will be given at Month 0 (Day 0) and Month 6 (Day 182), the meningitis vaccine, Menveo, given at Month 1 (Day 28), and a rabies vaccine, Rabivax-S, given at Month 3 (Day 98), Month 4 (Day 126) and Month 5 (Day 154). All will be given as a intramuscular injections.
Rabivax-S
Rabivax-S is an inactivated, freeze-dried, single-dose vaccine. The vaccine contains purified, inactivated rabies antigen produced using Vero ATCC CCL 81 cells as the cell substrate, Pitman Moore (PM3218) as the virus strain, and sucrose, glycine and HSA (Human Serum Albumin) as excipients
Menveo
Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.
Avaxim 80
Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).
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
Rabivax-S
Rabivax-S is an inactivated, freeze-dried, single-dose vaccine. The vaccine contains purified, inactivated rabies antigen produced using Vero ATCC CCL 81 cells as the cell substrate, Pitman Moore (PM3218) as the virus strain, and sucrose, glycine and HSA (Human Serum Albumin) as excipients
Menveo
Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.
Avaxim 80
Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).
Eligibility Criteria
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Inclusion Criteria
* Parent/guardian provides signed/thumb-printed informed consent
* Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and the duration of follow-up
Exclusion Criteria
* 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.
* 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 another 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.
* Known maternal HIV infection (no testing will be done by the study team).
* 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.
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
36 Months
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
European Vaccine Initiative
OTHER
Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)
UNKNOWN
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Halidou Tinto
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche en Sciences de la Sante, Burkina Faso
Locations
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Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)
Nanoro, , Burkina Faso
Countries
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Central Contacts
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Other Identifiers
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VAC087
Identifier Type: -
Identifier Source: org_study_id