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Malaria,FalciparumPhase 1VAC093NCT06958198

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

A Phase 1 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 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. Read more about this study

Who is it for?
Ages 5 months to 35 yearsHealthy volunteers can take part
Conditions the study is for
Malaria,Falciparum
What is being tested?
R21, RH5.1 and R78C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBurkina Faso
Study dates
15 Sep 2025to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 months to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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 -

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Institut de Recherche en Sciences de la Santé

    Siglé, Boulkiemdé Province, BP 7192 OUAGADOUGOU 03, BF

Other trials in Burkina Faso

About this study

Official title: 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

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.

Read the detailed description

There will be six study groups. Group 1 will consist of 8 adults who will receive three doses of 5 µg R21 + 10 µg RH5.1 + 10 µg R78C. Group 2 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1. Group 3 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg R78C. Group 4 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1 +10 µg R78C. Group 5 will consist of 8 children who will receive three doses of 5 µg R21. Group 6 will consist of 16 children who will receive three doses of 10 µg RH5.1 +10 µg R78C. All vaccinations will be given in 50 µg Matrix-M. All groups will receive their vaccinations in a 0-1-6 month regimen.

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.

Being tested
R21, RH5.1, R78C, Matrix-M™
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

Study groups in NCT06958198
Study groupRoleWhat they receive
Group 1(n=8) adults (18-35years)ExperimentalThey 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)
Receives: Biological: R21; Biological: RH5.1; Biological: R78C; Biological: Matrix-M™
Group 2 (n=8) Children aged between 5-17monthsExperimentalThey 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)
Receives: Biological: R21; Biological: RH5.1; Biological: Matrix-M™
Group 3 (n=8) children aged between 5-17 monthsExperimentalThey 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)
Receives: Biological: R21; Biological: R78C; Biological: Matrix-M™
Group 4 (n=8) Children aged between 5-17 monthsExperimentalThey 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)
Receives: Biological: R21; Biological: RH5.1; Biological: R78C; Biological: Matrix-M™
Group 5 (n=8) children aged 5-17 monthsExperimentalThey 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)
Receives: Biological: R21; Biological: Matrix-M™
Group 6 ( n=16) Children 5-17 monthsExperimentalThey 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)
Receives: Biological: RH5.1; Biological: R78C; Biological: Matrix-M™

What is being measured

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

  1. Safety: To assess the safety and reactogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.

    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed:

    • Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days)
    • Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days)
    • Occurrence of unsolicited adverse events for 28 days following the vaccination (day of vaccination and 27 subsequent days)
    • Clinically significant change from baseline for safety laboratory measures throughout the study
    • Occurrence of serious adverse events during the whole study duration.

    Measured: Solicited AEs will be assessed at Day 0, Days 1-6, 28, days 29-34, 182 and days 187. Unsolicited AEs on Day 0, Days 1-6, 14, 28, Days 29-34, 42, 56, 182, Days 183-187 and 196. All SAEs will be assessed throughout the study follow up period upto Day 365

Secondary outcomes (1)

  1. Immunogenicity: To assess the humoral immunogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.

    Immunogenicity will be assessed by a variety of immunological assays. The following measures will be assessed:

    • Serum response:
    • Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity;
    • In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay

    Measured: Immunology blood samples will be collected at screening, day of vaccination, at Days 42, 56, 182, 196, 210, 240, and 365.

Timeline

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

  1. First posted6 May 2025
  2. Study start15 Sep 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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. 8 healthy adults aged 18-35 years and 48 children aged 5-17 months living in a malaria endemic area will be recruited at one site in Burkina Faso. Adults will be recruited into one group receiving the combination of R21 + RH5.1 + R78C in Matrix-M. Children will be recruited into four groups receiving the combination of the three vaccines, R21 + RH5.1/Matrix-M, R21 + R78C/Matrix-M, R21/Matrix-M only or RH5.1 + R78C/Matrix-M only. Follow-up will be for 6 months post third vaccination.
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958198
Sponsor's protocol ID
VAC093
Acronym
VAC093
Status last verified
Jul 2026
First submitted
23 Apr 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: To assess the safety and reactogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area. (time frame: Solicited AEs will be assessed at Day 0, Days 1-6, 28, days 29-34, 182 and days 187. Unsolicited AEs on Day 0, Days 1-6, 14, 28, Days 29-34, 42, 56, 182, Days 183-187 and 196. All SAEs will be assessed throughout the study follow up period upto Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06958198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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