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Experimental infection and protection against ... - TI Pharma

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106 Chapter 5<br />

Figure 1. Time to microscopically detected parasitemia by cohort<br />

Survival curve for four cohorts: RUNMC I (orange), RUNMC II (blue), USMMVP<br />

(grey) <strong>and</strong> Oxford (green).<br />

Unsolicited adverse events were infrequent <strong>and</strong> never severe, <strong>and</strong> all resolved<br />

spontaneously. Events included vasovagal collapse, epistaxis, flatulence,<br />

insomnia, tinnitus, hyperesthesia, psychiatric complaints associated with<br />

chloroquine [7], pleuritic chest pain, sore throat, migraine, gingivitis,<br />

palpitations, numbness in fingers, dizziness, drowsiness, photosensitivity <strong>and</strong><br />

stiff neck.<br />

Laboratory safety parameters<br />

Clinical laboratory parameters in RUNMC <strong>and</strong> USMMVP did not show significant<br />

abnormalities in haemoglobin content; parameters were not routinely available<br />

in Oxford. The majority of volunteers experienced a mild to moderate decrease<br />

in leucocyte count, none of which was severe (

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