Safety assessment
myalgia, fatigue, fever, abdominal pain, diarrhea, swelling, chest pain, erythema, pain, dizziness, pruritis, sweats, headache, nausea,, tenderness, chills
DISEASES, ADVERSE EVENTS, ADVERSE EVENT, ERYTHEMA, INDURATION
All participants received a memory aid booklet to register symptoms and an oral thermometer to record daily temperature. Adverse events were recorded by the attending physician and graded as mild (easily tolerated, grade 1), moderate (interfering with daily activity, grade 2), or severe (preventing daily activity, grade 3) and in the case of fever as mild (38.0–38.4 °C), moderate (38.5–38.9 °C), or severe (≥ 39 °C). Adverse events were categorized by the International Classification of Diseases 10 code. Systemic solicited adverse events were defined as: fever (by examination), headache, fatigue, malaise, chills, myalgia, dizziness, sweats, nausea, vomiting, abdominal pain, diarrhea, and chest pain. Local solicited adverse events were tenderness, induration, erythema, swelling, pain, and pruritis. Causality to the study procedures was categorized as not related, possibly related, or probably related. Safety blood tests were performed once daily at each study visit, including hematology and biochemistry safety evaluations (including LDH and highly sensitive troponin T) and liver function tests. A thick smear was performed on days 7, 8, and 9 after immunization (cohort A) or if participants were symptomatic (cohort A and B) to detect breakthrough infection. 0.5 μL of blood was assessed by microscopy and considered positive if two unambiguous parasites were detected. Mefloquine and atovaquone levels were measured retrospectively in citrate-plasma by liquid chromatography (limit of detection 20 ng/mL). Artemether and lumefantrine levels were measured retrospectively in citrate-plasma by high performance liquid chromatography coupled to tandem mass spectrometry [