Malaria,FalciparumPhase 1/2NCT05790889
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
A Phase 1/2 study testing Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M and RH5.2 5μg adjuvated with 50μg Matrix-M in people with Malaria,Falciparum, run by University of Oxford at 1 site in Burkina Faso.
Trial summary
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso Read more about this study
- Who is it for?
- Ages 5 to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M and RH5.2 5μg adjuvated with 50μg Matrix-M
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 3 Apr 2023to 16 Oct 2026
- Phase
- Phase 1/2
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 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant aged 5-17 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 follow-up for 12 months following last dose of vaccination.
Who cannot join
- 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 immunization.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Sickle cell disease.
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- Clinically significant laboratory abnormality as judged by the study clinician.
- 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 7 days preceding enrolment, or planned receipt of any other vaccine within 7 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.
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
About this study
Official title: A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
Read the detailed description
During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M.
During recruitment to Groups 3, 4 and 5, participants will be randomised 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5).
There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from final vaccination.
The trial is funded by EDCTP grant number RIA2016V-1649-MMVC and by a Wellcome Trust Translational Award (205981/Z/17/Z)
- Conditions
- Malaria,Falciparum
- Being tested
- Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M, RH5.2 5μg adjuvated with 50μg 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.
Rabies vaccineBiological
Vaccine
RH5.1 10μg adjuvated with 50μg Matrix-MBiological
Vaccine
RH5.2 5μg adjuvated with 50μg Matrix-MBiological
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | Placebo comparator | n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 152. Receives: Biological: Rabies vaccine |
| Group 2 | Experimental | n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 152. Receives: Biological: RH5.1 10μg adjuvated with 50μg Matrix-M |
| Group 3 (Control Group) | Placebo comparator | n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 56. Receives: Biological: Rabies vaccine |
| Group 4 | Experimental | n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56. Receives: Biological: RH5.1 10μg adjuvated with 50μg Matrix-M |
| Group 5 | Experimental | n=120 Age= 5-17 months First vaccination of RH5.2-VLP 5μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56. Receives: Biological: RH5.2 5μg adjuvated with 50μg Matrix-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature higher than 37.5 degree celsius and P. Falciparum parasite density >5000 asexual forms/µL)
Measured: From 14 days after the third study vaccination until 6 months after the third study vaccination.
To assess the safety and reactogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
Measured: The month following each vaccination and at 6 and 12 months after administration of the final dose of vaccine.
Secondary outcomes (8)
To assess the humoral immunogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
The following measures will be assessed
- Serum ELISA response:
- Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity; 2. Antigen-specific antibody subclass/isotype measurement; 3. Antigen-specific antibody avidity measurement; In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay
- Purified IgG ELISA versus GIA titration "Quality Analysis"
Measured: Immunology blood samples will be collected at screening, day of vaccination (V) 1, 14 & 28 days post V2, day of V3, 14 days post V3, 2, 6 and 12 months post V3.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 3 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL).
Measured: From 14 days after the third study vaccination until 3 months after the third study vaccination
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area
Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
Measured: For 12 months after the last vaccination
To assess the protective efficacy against asymptomatic P. falciparum infection of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
Efficacy tested by conducting qPCR analysis
Measured: At 6 and 12 months after administration of the final dose of vaccine.
To assess the protective efficacy against asymptomatic P. falciparum infection against gametocytaemia of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
The proportion of participants in each study arm that show presence of parasite density >5000 asexual forms/µL as measured by quantitative reverse-transcriptase PCR PLUS presence of axillary temperature <37.5°C and absence of history of fever within the last 24 hours. The proportion of participants in each study arm that show presence of parasite density >0 asexual forms/µL as measured by quantitative reverse-transcriptase PCR PLUS presence of axillary temperature <37.5°C and absence of history of fever within the last 24 hours.
Measured: At 6 and 12 months post third study vaccination.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area for 12 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL).
Measured: From 14 days after the third study vaccination until 12 months after the third study vaccination
To assess the protective efficacy against gametocytaemia of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area, by qPCR at 2 and 6 months after administration of the final dose of vaccine
The proportion of participants in each study arm that show presence of gametocytes >0 gametocytes/μL as measured by quantitative reverse-transcriptase PCR.
Measured: At 2 and 6 months post third study vaccination.
Efficacy against incident severe anaemia and blood transfusion requirement
The proportion of participants in each study arm with documented Hb <5.0 g/dL identified at clinical presentation in association with P. falciparum asexual parasitaemia > 5000 parasites/µL. The proportion of participants in each study arm with documented Hb <5.0 g/dL identified at clinical presentation and requirement for a blood transfusion.
Measured: From 14 days after the third study vaccination until 6 months after the third study vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start3 Apr 2023
- Primary completion16 Oct 2026
- Study completion16 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, European and Developing Countries Clinical Trials Partnership (EDCTP), Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Angela Minassian, Principal investigator, Honorary Consultant and Chief Investigator - Project clinical trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790889
- Sponsor's protocol ID
- VAC091
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Natama HM, Salkeld J, Some A, Soremekun S, Diallo S, Traore O, Rouamba T, Ouedraogo F, Ouedraogo E, Dabone KCS, Kone NA, Compaore ZMJ, Kafando M, Bonko MDA, Konate F, Sorgho H, Nielsen CM, Pipini D, Diouf A, King LDW, Shaligram U, Long CA, Cho JS, Lawrie AM, Skinner K, Roberts R, Miura K, Bradley J, Silk SE, Draper SJ, Tinto H, Minassian AM. Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. Lancet Infect Dis. 2025 May;25(5):495-506. doi: 10.1016/S1473-3099(24)00752-7. Epub 2024 Dec 10.
PubMed 39672183