Seasonal mass vaccination with R21/Matrix-M for malaria elimination (SERVAL): protocol of the cluster randomised...

Area of Science:

• Global Health
• Vaccinology
• Infectious Disease Epidemiology

Background:

• Malaria control progress has plateaued since 2015, necessitating novel interventions.
• The R21/Matrix-M (R21) malaria vaccine, recently WHO-approved for children, shows promise.
• This trial addresses the need for tools to reduce malaria transmission.

Purpose of the Study:

• To assess the impact of seasonal mass vaccination with R21 on malaria transmission.
• To evaluate R21 vaccine efficacy and safety in diverse transmission settings.
• To determine the cost-effectiveness of R21 mass vaccination strategies.

Main Methods:

• A multi-center, open-label, cluster-randomized controlled trial in The Gambia and Burkina Faso.
• Villages randomized to receive seasonal R21 vaccination or control, with booster doses.
• Primary outcome: malaria prevalence at peak transmission; secondary outcomes: safety, incidence, coverage, acceptability, and cost.

Main Results:

• Primary outcome data on malaria prevalence at peak transmission (November 2024) are pending.
• Secondary outcome data on safety, tolerability, and vaccination coverage will be collected.
• Community acceptability and cost-effectiveness analyses will be performed.

Conclusions:

• This is the first trial of seasonal mass vaccination with R21 targeting malaria transmission reduction.
• The study design accounts for varying transmission intensities and age groups.
• Successful implementation could accelerate malaria elimination efforts globally.