Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malaria Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Arm

Children aged 5-36 months will receive R21 via routine EPI vaccination (Year round in Burkina faso, or prior to the malaria season and SMC delivery in Mali)

Group Type NO_INTERVENTION

No interventions assigned to this group

Integrated SMC Vaccination

Children aged 3-59 months will receive 3-dose primary series aligned with SMC distribution in an annual campaign

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Control arms :

* 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.

Intervention arms :

* Children aged 3-59 months at the time of first study vaccination;
* Resident in the catchment area of a health centre assigned to the intervention arm;
* Willingness to comply with the study procedures;
* Written informed consent from Parent/Guardian.

Exclusion Criteria

1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
2. Any history of anaphylaxis in relation to vaccination;
3. Known chronic illness;
4. 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;
5. History of vaccination with another malaria vaccine. -

Minimum Eligible Age

3 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes