Status:
NOT_YET_RECRUITING
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Institut de Recherche en Sciences de la Sante, Burkina Faso
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Malaria,Falciparum
Eligibility:
All Genders
5-36 years
Phase:
PHASE2
Brief 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™, i...
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 Bu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07183371
Start Date
December 1 2025
End Date
December 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)
Nanoro, Burkina Faso