Approval for this study was obtained from the Faculty of Medicine, Pharmacy and Odonto-Stomatology Ethics Committee; and the Institutional Review Board at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. Written, informed consent was obtained from adult participants, and from the parents or guardians of participating children. The study was externally monitored for protocol compliance, data integrity, and human subjects protections.
This study is part of an ongoing observational study of the acquisition and maintenance of malaria immunity that began in May 2006. Individuals were invited to be screened for the study after being randomly selected from an age-stratified census of the entire village population. Enrollment exclusion criteria were hemoglobin <7 g/dL, fever ≥37.5°C, acute systemic illness, use of anti-malarial or immunosuppressive medications in the past 30 days, or pregnancy. Venous blood samples and blood smears were collected before the malaria season (May 2006), at cross-sectional time points every 2 months during the malaria season (July, October, and December 2006), prior to the second malaria season (May 2007), and 14 days after the first episode of malaria. Stool and urine were examined at enrollment for the presence of helminth infections. Participants were encouraged to report symptoms of malaria at the village health center, staffed 24 hours per day by a study physician. From those with signs or symptoms of malaria, blood smears were prepared and examined for the presence of P. falciparum. Slide positive patients were treated with a standard 3-day course of artesunate plus amodiaquine, following the guidelines of the Mali National Malaria Control Program. Children with severe malaria were referred to Kati District Hospital after an initial parenteral dose of quinine. The research definition of malaria was an axillary temperature ≥37.5°C, P. falciparum asexual parasitemia ≥5000/μl, and a non-focal physical exam by the study physician. Severe malaria, as defined by the WHO [14 (link)], was included in this definition. At the end of the malaria season, participants (or their parents or guardians in the case of children) were asked whether or not they had used a bednet nightly during the rainy season.
This study is part of an ongoing observational study of the acquisition and maintenance of malaria immunity that began in May 2006. Individuals were invited to be screened for the study after being randomly selected from an age-stratified census of the entire village population. Enrollment exclusion criteria were hemoglobin <7 g/dL, fever ≥37.5°C, acute systemic illness, use of anti-malarial or immunosuppressive medications in the past 30 days, or pregnancy. Venous blood samples and blood smears were collected before the malaria season (May 2006), at cross-sectional time points every 2 months during the malaria season (July, October, and December 2006), prior to the second malaria season (May 2007), and 14 days after the first episode of malaria. Stool and urine were examined at enrollment for the presence of helminth infections. Participants were encouraged to report symptoms of malaria at the village health center, staffed 24 hours per day by a study physician. From those with signs or symptoms of malaria, blood smears were prepared and examined for the presence of P. falciparum. Slide positive patients were treated with a standard 3-day course of artesunate plus amodiaquine, following the guidelines of the Mali National Malaria Control Program. Children with severe malaria were referred to Kati District Hospital after an initial parenteral dose of quinine. The research definition of malaria was an axillary temperature ≥37.5°C, P. falciparum asexual parasitemia ≥5000/μl, and a non-focal physical exam by the study physician. Severe malaria, as defined by the WHO [14 (link)], was included in this definition. At the end of the malaria season, participants (or their parents or guardians in the case of children) were asked whether or not they had used a bednet nightly during the rainy season.
