Malaria,FalciparumPhase 2VAC087NCT07183371

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M

A Phase 2 study testing R21, RH5.1 and R78C in people with Malaria,Falciparum, run by University of Oxford at 1 site in Burkina Faso.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 5 to 36 monthsHealthy volunteers can take part
Conditions the study is for: Malaria,Falciparum
What is being tested?: R21, RH5.1 and R78C
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 1 siteBurkina Faso
Study dates: 15 Dec 2025to Mar 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 36 months
All sexes
Healthy volunteers accepted
Child

Inclusion Criteria: Only participants who meet all the inclusion criteria will be enrolled into the trial:

Healthy infant aged 5-36 months at the time of first study vaccination
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: 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.
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.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)
Nanoro

Other trials in Burkina Faso

About this study

Official title: 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

Read the detailed description

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.

Conditions: Malaria,Falciparum
Being tested: R21, RH5.1, R78C, Matrix-M™, Rabivax-S
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

R21Biological
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1Biological
A soluble protein vaccine against the RH5 antigen
R78CBiological
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™Biological
A saponin-based vaccine adjuvant
Rabivax-SBiological
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
MenveoBiological
Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.
Avaxim 80Biological
Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).

Study groups in NCT07183371
Study group	Role	What they receive
Group 1 (n=120) children 5-36 months	Experimental	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. Receives: Biological: R78C; Biological: Matrix-M™; Biological: Rabivax-S
Group 2 (n=120) children 5-36 months	Experimental	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. Receives: Biological: R21; Biological: RH5.1; Biological: R78C; Biological: Matrix-M™
Group 3 (n=120) children 5-36 months	Placebo comparator	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. Receives: Biological: Rabivax-S; Biological: Menveo; Biological: Avaxim 80

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Throughout study completion, an average of 1 year

Secondary outcomes (6)

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months after administration of the final dose of vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 2025Mar 2027

First posted19 Sep 2025
Study start15 Dec 2025
Primary completionMar 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
More trials run by University of OxfordThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a Phase IIb, double-blinded, block randomised, controlled trial to assess the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidate R78C in Matrix-M and the multi-stage combination of the blood-stage malaria vaccine candidates RH5.1 and R78C in Matrix-M and the pre-erythrocytic malaria vaccine R21 in Matrix-M. 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07183371
Sponsor's protocol ID: VAC087
Acronym: VAC087
Status last verified: Oct 2026
First submitted: 2 Jul 2025
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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Questions to ask the study team

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Could I receive a placebo instead of the treatment?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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