Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

NCT06860178 | Recruiting Phase 4 DMC

• 1 other identifier: IMVACS
• Study Type: interventional
• Target: 40,000
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Malaria Vaccine

Keywords

malaria; CPS; pediatric; vaccine; R21

Outcome Measures

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

  from enrollment to 12 months

Secondary Outcomes (10)

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

  From enrollment to 2 years after booster

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

  From enrollment to 2 years after booster

• Malaria prevalence at peak transmission

  From enrollment to 2 years after booster dose

• Vaccine coverage

  From enrollment to months 24

• Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;

  From enrollment to months 4

Study Arms (2)

Control Arm

NO INTERVENTION

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)

Integrated SMC Vaccination

OTHER

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

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

Interventions

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

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

Integrated SMC Vaccination

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of vaccination with another malaria vaccine. -

Sponsors & Collaborators

• Epicentre: lead
• R-Evolution Worldwide: collaborator
• CNRST Burkina Faso: collaborator
• USTTB Mali: collaborator
• Liverpool School of Tropical Medicine: collaborator

Study Sites (2)

Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest

Ouagadougou, Burkina Faso

RECRUITING

University of Sciences Techniques and Technologies of Bamako

Bamako, Mali

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Valérie Briand

CONTACT

+331 40 21 55 55; valerie.briand@epicentre.msf.org

Soazic Gardais

CONTACT

+331 40 21 55 55; soazic.gardais@epicentre.msf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: March 5, 2025
• Study Start: June 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

MA (1); BU (1)