Actively Recruiting
Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
Led by Epicentre · Updated on 2025-08-08
40000
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
Sponsors
E
Epicentre
Lead Sponsor
R
R-Evolution Worldwide
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness. Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.
CONDITIONS
Official Title
Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 36 months in Burkina Faso and Mali for control arms
- Children aged 3 to 59 months in intervention arms
- Resident in the catchment area of a health centre assigned to the respective study arm
- Willingness to comply with study procedures
- Written informed consent from parent or guardian
You will not qualify if you...
- History of allergic disease or reactions likely worsened by any vaccine component
- History of anaphylaxis related to vaccination
- Known chronic illness
- Any significant disease or condition that may risk participant or affect study results
- Previous vaccination with another malaria vaccine
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest
Ouagadougou, Burkina Faso
Actively Recruiting
2
University of Sciences Techniques and Technologies of Bamako
Bamako, Mali
Actively Recruiting
Research Team
V
Valérie Briand
CONTACT
S
Soazic Gardais
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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