Health Trials

Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

ConditionMalaria Vaccine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-59
SponsorEpicentre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;

Resident in the catchment area of a health centre assigned to the control arm;

Willingness to comply with the study procedures;

Written informed consent from Parent/Guardian.

Disqualifiers

History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;

Any history of anaphylaxis in relation to vaccination;

Known chronic illness;

Any other 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 design

Design model

Parallel

Treatments tested in this trial

  • Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months

    Other intervention

    in the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS

Treatment groups

40,000 Participants
are divided into 2 treatment groups
Group A: Control ArmNo intervention 0 interventions
Group B: Integrated SMC VaccinationOther 1 intervention

Trial outcomes

Primary outcomes

1

Malaria Incidence on 5-36 months at 12 months

Malaria incidence among children aged 5-36 months over 12 months post first dose using routine surveillance activities for clinical malaria detection and reporting

Time frame
from enrollment to 12 months

Secondary outcomes

1

Malaria incidence among children aged 5-36 months over 24 and 36 months

Malaria incidence among children aged 5-36 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting;

Time frame
From enrollment to 2 years after booster
2

Malaria incidence among children aged 3-59 months over 24 and 36 months

Malaria incidence among children aged 3-59 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting

Time frame
From enrollment to 2 years after booster
3

Malaria prevalence at peak transmission

Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026

Time frame
From enrollment to 2 years after booster dose
4

Vaccine coverage

Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination

Time frame
From enrollment to months 24

Other outcomes

Sponsors and contacts

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Epicentre

Lead sponsor

R-Evolution Worldwide

Collaborator

CNRST Burkina Faso

Collaborator

USTTB Mali

Collaborator

Liverpool School of Tropical Medicine

Collaborator

Source ClinicalTrials.gov
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