Building multidisciplinary evidence to support Integrating Malaria VACcine with Seasonal malaria chemoprevention in West Africa

Despite available efficacy data on two malaria vaccines designed for broad use, there is little evidence about scalable delivery strategies in areas with seasonal malaria transmission.

We propose a multi-site, multi-disciplinary Phase IV cluster-randomized trial in Burkina Faso and Mali to evaluate the effectiveness, real-life impact, acceptability, feasibility and cost-effectiveness of a novel integrated delivery strategy of R21/Matrix-M in areas with highly seasonal malaria transmission.We will compare campaign-style vaccination co-administered during Seasonal Malaria Chemoprevention to vaccination following an age-based strategy in routine Essential Programme on Immunisation activities using a non-inferiority design.

We will engage with all stakeholders to co-design the integrated strategy, collect malaria incidence data via surveillance and prevalence via cross-sectional surveys, generate data on coverage, assess feasibility and acceptability among stakeholders and end-users using qualitative longitudinal study methods, and describe the cost-effectiveness of both approaches, with costs and outcomes measured from the societal perspective.

We will also use the trial platform to perform post-licensure pharmacovigilance of R21/Matrix-M.

The project will ensure translation of results into policy and practice throughout areas of highly seasonal malaria transmission.

It responds to SDG3, and is aligned with the Immunization Agenda 2030, particularly by testing a community-based vaccine approach that should reduce the number of “zero-dose” children. By leveraging the SMC platform, we hope to mitigate vaccine hesitancy.

Our multi-disciplinary approach aims to generate a comprehensive package of evidence that will allow policymakers to make informed guidelines for malaria vaccine schedules and delivery in the Sahel, at the same time reinforcing health systems and promoting synergies between malaria and vaccination programs in support of the Primary Health Care agenda.