A Phase 2 interventional study of R21 and RH5.1 in Malaria,Falciparum, sponsored by University of Oxford. Active, not recruiting at 1 site in Burkina Faso. Open to participants aged 5 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University of Oxford · Phase 2, Interventional, and Prevention
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the malaria vaccine candidates R78C with Matrix-M™, and the combination of RH5.1 and R21 with Matrix-M™, in children aged 5-36 months in Burkina Faso.
There will be three study groups, each comprising of 120 children aged between 5 and 36 months at the time of first vaccination living in a malaria endemic area and 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.
384 studies on the registry are indexed under Malaria, Falciparum; 38 are open to participants now.
This study's planned enrollment of 360 is above the median of 132 across 319 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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Inclusion Criteria: Only participants who meet all the inclusion criteria will be enrolled into the trial:
Exclusion Criteria: The participant may not enter the trial if ANY of the following apply:
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 If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event:
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adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator.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:
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.
Biological: R78C · Biological: Matrix-M™ · Biological: Rabivax-S
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.
Biological: R21 · Biological: RH5.1 · Biological: R78C · Biological: Matrix-M™
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.
Biological: Rabivax-S · Biological: Menveo · Biological: Avaxim 80
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
A soluble protein vaccine against the RH5 antigen
A soluble RIPR EGF-CyRPA fusion protein vaccine
A saponin-based vaccine adjuvant
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 is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.
Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).
Efficacy: The primary efficacy outcome is clinical malaria, defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL.
To assess the protective efficacy against clinical malaria of R78C with Matrix-M™, and the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™, in children living in a malaria-endemic area, for 6 months after the final vaccination. Primary case definition for clinical malaria: • Presence of axillary temperature ≥37.5°C and/or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia \> 5000 parasites/µL Secondary case definitions for clinical malaria: * Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND EITHER P. falciparum asexual parasitaemia \>0 parasites/µL OR positive RDT * Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia \>20,000 parasites/µL
Time frame: Clinical malaria will be assessed 6 months post final vaccination
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-M™ by assessing solicited adverse events (AEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
The occurrence of solicited local and systemic reactogenicity signs and symptoms will be assessed for 7 days following each vaccination (day of vaccination and 6 subsequent days) Foreseeable adverse reactions following vaccination with RH5.1, R78C or R21 and Matrix-MTM adjuvant are: * Local reactions: pain, erythema, warmth, swelling * Systemic reactions: drowsiness, fever, irritability/fussiness, loss of appetite These AEs will be listed as 'solicited AEs' providing they occur within 7 days of the day of vaccination.
Time frame: Day 0,1-6,28,29-34,98,99-104,126,127-132,154,155-160,182,183-188.
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-M™ by assessing unsolicited adverse events (AEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
The occurrence of unsolicited AEs will be assessed for 7 days following each vaccination (day of vaccination and 6 subsequent days). Unsolicited AEs' are AEs other than the foreseeable adverse reactions occurring within the first 7 days, or any AEs occurring after the first 7 days after vaccination. For every unsolicited AE, an assessment of the relationship of the event to the administration of the vaccine will be undertaken by the PI or the PI-delegated clinician. An intervention-related AE refers to an AE for which there is a possible, probable or definite relationship to administration of a vaccine. An interpretation of the causal relationship of the intervention to the AE in question will be made, based on the type of event; the relationship of the event to the time of vaccine administration; and the known biology of the vaccine therapy
Time frame: Day 0,1-6,14,28,29-34,42,56,98,99-104,112,126,127-132,140,154,155-160,168,182,183-188,196.
Safety: To assess the safety and reactogenicity of R78C, RH5.1 and R21 with Matrix-M™ by assessing serious adverse events (SAEs) in children living in a malaria-endemic area until 6 months after administration of the final dose of vaccine.
The occurrence of SAEs during the whole study duration. An SAE is an AE that results in any of the following outcomes, whether or not considered related to the study intervention: * Death. * Life-threatening event. This does not include an AE that, if it occurred in a more severe form, might have caused death. * Persistent or significant disability or incapacity. * Hospitalisation or prolongation of hospitalisation, regardless of length of stay, even if it is a precautionary measure for continued observation. Hospitalisation for a pre-existing condition that has not worsened unexpectedly does not constitute an SAE. * An important medical event that may, based upon appropriate medical judgment, jeopardise the volunteer and/or require medical or surgical intervention to prevent one of the outcomes listed above. * Congenital anomaly or birth defect.
Time frame: Throughout study completion, an average of 1 year
Immunogenicity:To assess the humoral immunogenicity of R78C with Matrix-M™, and the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™ in children living in a malaria-endemic area.
Humoral immunogenicity will be assessed from blood samples taken at various timepoints. Immunogenicity will be determined following the quantification of antigen-specific IgG antibody levels (µg/mL readout) over time, as well as by in vitro growth inhibition assays (GIA) against P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay.
Time frame: Blood samples for immunogenicity will be taken at Day -30 to 0, 0, 42, 56, 182, 196, 238, and 350.
Efficacy: To assess the protective efficacy against clinical malaria of R78C with Matrix-M™, in children living in a malaria-endemic area, for 3 months after the final vaccination
The definition for clinical malaria is as follows: 1. Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND EITHER P. falciparum asexual parasitaemia \>0 parasites/µL OR positive RDT or 2. Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia \>20,000 parasites/µL Efficacy will be determined following the comparison of mean parasite density in each study arm
Time frame: 3 months after the final vaccination
Efficacy: To assess the protective efficacy against clinical malaria of the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™, in children living in a malaria-endemic area, for 3 months after the final vaccination
The definition for clinical malaria is as follows: 1. Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND EITHER P. falciparum asexual parasitaemia \>0 parasites/µL OR positive RDT or 2. Presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours AND P. falciparum asexual parasitaemia \>20,000 parasites/µL Efficacy will be determined following the comparison of mean parasite density in each study arm
Time frame: 3 months after the final vaccination
Efficacy: To assess the protective efficacy against asymptomatic P. falciparum infection of R78C with Matrix-M™, and the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™, in children living in a malaria-endemic area.
This will be measured by looking at the following: * Proportion of participants in each study arm that show presence of parasite density \>5000 asexual forms/µL as measured by quantitative reverse-transcriptase PCR (qRT-PCR) from 14 days to 2 and 6 months after administration of the final study vaccination PLUS presence of axillary temperature \<37.5°C and absence of history of fever within the last 24 hours * Proportion of participants in each study arm that show presence of parasite density \>0 asexual forms/µL as measured by qRT-PCR from 14 days to 2 and 6 months after administration of the final study vaccination PLUS presence of axillary temperature \<37.5°C and absence of history of fever within the last 24 hours * Parasite density in those with \>0 asexual forms/µL as measured by qRT-PCR from 14 days to 2 and 6 after administration of the final study vaccination PLUS presence of axillary temperature \<37.5°C and absence of history of fever within the last 24 hours
Time frame: 2 and 6 months after administration of the final dose of vaccine
Efficacy: To assess the protective efficacy against gametocytaemia of R78C with Matrix-M™, and the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™, in children living in a malaria-endemic area
Protective efficacy against gametocytaemia will be assessed by measuring the proportion of participants in each study arm that show the presence of gametocytes \>0 gametocytes/μL as measured by qRT-PCR from 14 days to 2 and 6 months after administration of the final study vaccination
Time frame: 2 and 6 months after administration of the final dose of vaccine
Efficacy: To assess the protective efficacy of R78C with Matrix-M™, and the combination of RH5.1 with Matrix-M™ and R21 with Matrix-M™, against prevalent moderate or severe anaemia at 6 months after administration of the final dose of vaccine
Prevalent severe anaemia is defined as a documented haemoglobin (Hb) level \<5.0 g/dL. Prevalent moderate anaemia is defined as a documented Hb level \<8.0 g/dL.
Time frame: 6 months after administration of the final dose of vaccine
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