The project comprised a series of 5 inter-related cohorts that compared groups receiving malaria drug interventions versus groups receiving no malaria intervention, and assessed the impact of these treatments on immunological and vaccine response endpoints. The studies were conducted at various sites around Bamako, Mali, where malaria transmission is intense during the rainy season (Jul-Dec) and is minimal during the dry season (Jan-Jun). In 3 of the 5 cohorts, the volunteers were drawn from among the participants in ongoing vaccine or drug trials. All cohorts have been completed other than Cohort 4, in which Malian adults were randomized to receive Coartem versus no Coartem at the beginning of the dry season. This cohort, originally planned for Doneguebougou village, was re-located to Ouelessebougou where the studies in children were conducted (Cohorts 1 and 5), to allow comparisons between adults and children at the same site. Cohort 4 will be completed in January 2018, and will be reported in a Supplemental report in early 2018. In this report, T cell data are generally reported as fold-change in percentages of T cell subsets (eg, CD4+ PD1+ T cell as a percentage of total CD4+ T cells) following assignment to treatment groups. For most cases in this report, each cohort has been analyzed by GEE modeling in unadjusted analyses. In future, we will perform conditional GEE models that adjust for other covariates of interest (eg, count of unique malaria infections, additional treatment for parasitemia, age, etc). Of note, intercurrent malaria episodes requiring treatment occurred throughout followup of the different cohorts, and the impact of these needs to be explored for their effects on immunologic endpoints. Adjusted GEE model results will be reported in a Supplemental report in early 2018.

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8
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2018
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