Principal Investigator: Alassane Dicko, University of Bamako
NIH-Supported Collaborator: Patrick Duffy, National Institute of Allergy and Infectious Disease (NIAID)
Title of NIH Award: Malaria Immunology and Pathogenesis in Pregnant Women and Young Children
Malaria is the leading cause of morbidity and mortality in Mali. Despite effective implementation of usual control measures such as insecticide treated nets (ITN) and artemisinin combination therapy (ACT) malaria remains the number one killer in Mali. We recently showed that Seasonal Malaria Chemoprevention (SMC), previously known as Intermittent Preventive Treatment of Malaria in children, reduces malaria infection and disease by more 80% in Malian children, prompting the WHO to approve SMC as policy for countries with seasonal malaria transmission, such as Mali, in March 2012. The strategy is a highly cost-effective approach to reduce childhood mortality in these areas. Despite the huge benefit of the SMC on malaria infection and disease, the optimal approach to deliver SMC remains to be determined and there is no data on the long term effect of this strategy on the development of immunity to malaria. An optimal SMC delivery approach will make a substantial contribution toward the achievement of the goals of the US President’s Malaria Initiative (PMI) and the Millenium Development Goals.
The objectives of the study are to identify the most effective method to deliver SMC, and to obtain information on the long term impact of SMC on malaria immunity.
The design is a cluster-randomized trial over three years. By using a step-wedge design, the investigators aim to i) determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly observed treatment (DOT) vs. non-DOT (NDOT)) and frequency (3 vs. 4 doses per season) of SMC delivery; ii) to compare quantitative measures of immunity in children who do and do not receive SMC over a three year period.
Public Health Impact:
The anticipated outcome of the study will be a qualified optimal approach to deliver SMC in Mali, and an expanded understanding of its impact on health outcomes and antimalarial immunity. The results will be shared with stakeholders, and will be used at the end of each year to guide the implementation of SMC in Mali.
Patrick Duffy has over 20 years of experience in malaria research, including malaria vaccine development and vaccine trials, as well as studies of malaria pathogenesis and immunity in pregnant women and children. Specifically, Dr. Duffy will provide support for the design and analysis of the primary study, and will participate in the assays of humoral and cellular responses to assess the effect of SMC on immunity in the populations under study.