Integrating Malaria Vaccine with Seasonal Malaria Chemoprevention in West Africa

Phase 4

Not yet recruiting

• Conditions: Malaria Vaccine

• Registration Number: NCT06860178
• Lead Sponsor: Epicentre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-04
• Primary Completion: 2026-05
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

Not provided

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Malaria Incidence on 5-36 months at 12 months	from enrollment to 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

Secondary Outcome Measures

Name	Time	Method
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 5-36 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting;
Malaria incidence among children aged 3-59 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 post first dose using routine surveillance activities for clinical malaria detection and reporting
Malaria prevalence at peak transmission	From enrollment to 2 years after booster dose	Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026
Vaccine coverage	From enrollment to months 24	Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;	From enrollment to months 4	Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination
Acceptability	From 12 months after study start to 36 months	Qualitative interviews and FGDs among policy makers, health managers, health providers and caregivers
Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group	From enrollment to months 36	Acceptability and feasibility studies will use qualitative longitudinal study (QLS) research methods. We will apply an ecological framework approach with emphasis on the interplay and inter-dependency between individual, interpersonal, organizational, and policy levels. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions. No quantitative measurements will be made.
Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake	From enrollment to months 24	Interviews and FGD - will be explained in a parallel protocol
Stakeholders and caregivers perceptions of the factors that enhance and/or constrain the succesful co,pletion of four doses of R21 and the key drivers of vaccination coverage	From enrollment to months 24 and 36	The study will cover a full, two-year R21/Matrix-M delivery cycle with data collection at two time points in each arm: soon after the primary series is delivered, and soon after the booster dose is provided a year later. This longitudinal approach will enable us to explore and chart dynamic processes as they occur, barriers and facilitators, and acceptability over time. It is inherently suitable for studying R21/Matrix-M introduction, requiring prolonged and repeated involvement by patients and providers. This approach is also necessary to explore the drivers of vaccine hesitancy which is not a static state; vaccine decision-making changes over time as caregivers experience different influences and nudges along the way. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions to explore factors in the service delivery, household, and broader social environments that will lead to R21 adoption and adherence. A
Incremental costs (per child vaccinated) and cost-effectiveness (per malaria case and separately, per DALY averted) of each vaccination strategy, calculated from a societal perspective	From enrollment to months 36	Costs associated with the different vaccination strategies will be estimated by collecting data on direct and indirect costs to health systems and opportunity costs to vaccinees and their caregivers (beneficiaries). Beneficiary costs will be collected during household surveys, via case report forms developed to collect data on direct costs (transport, food, medication) and indirect costs (time and income loss) incurred by their household related to each intervention arm. Provider costs will be collected using custom built spreadsheets structured to comprehensively capture the resources used for all intervention delivery related activities (excluding research activities) by cost category (person time, equipment, consumables including vaccines, storage, transport, overheads and other costs) by arm. Malaria incidence estimates (primary clinical outcome) will be used to calculate malaria cases and DALYs averted by arm, adjusted for intervention coverage (using the coverage survey data).

Trial Locations

Locations (2)

Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest; 🇧🇫 Ouagadougou, Burkina Faso

University of Sciences Techniques and Technologies of Bamako; 🇲🇱 Bamako, Mali