Experimental infection and protection against ... - TI Pharma
Experimental infection and protection against ... - TI Pharma Experimental infection and protection against ... - TI Pharma
Comparison of clinical and parasitological data from experimental human malaria challenge trials Correlations were assessed by Pearson’s correlation when parametric and Spearman’s when non-parametric. Two-sided p-values below 0.05 were considered significant unless stated otherwise. Results Demographics A total of 128 volunteers were grouped into three different cohorts: RUNMC I and II and Oxford and compared to published data from 47 infected individuals at USMMVP [6], for a total of 175 volunteers. Individuals were generally 20-40 years old, with equal distribution between male and female participants (Table 1). There were no significant differences in sex distribution between the different cohorts (Kruskal-Wallis, p=0.22), but RUNMC II volunteers were significantly younger (Kruskal-Wallis, p37.5°C) occurred with significant higher frequency in RUNMC and USMMVP. 105
106 Chapter 5 Figure 1. Time to microscopically detected parasitemia by cohort Survival curve for four cohorts: RUNMC I (orange), RUNMC II (blue), USMMVP (grey) and Oxford (green). Unsolicited adverse events were infrequent and never severe, and all resolved spontaneously. Events included vasovagal collapse, epistaxis, flatulence, insomnia, tinnitus, hyperesthesia, psychiatric complaints associated with chloroquine [7], pleuritic chest pain, sore throat, migraine, gingivitis, palpitations, numbness in fingers, dizziness, drowsiness, photosensitivity and stiff neck. Laboratory safety parameters Clinical laboratory parameters in RUNMC and USMMVP did not show significant abnormalities in haemoglobin content; parameters were not routinely available in Oxford. The majority of volunteers experienced a mild to moderate decrease in leucocyte count, none of which was severe (
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Comparison of clinical <strong>and</strong> parasitological data from experimental human malaria<br />
challenge trials<br />
Correlations were assessed by Pearson’s correlation when parametric <strong>and</strong><br />
Spearman’s when non-parametric. Two-sided p-values below 0.05 were<br />
considered significant unless stated otherwise.<br />
Results<br />
Demographics<br />
A total of 128 volunteers were grouped into three different cohorts: RUNMC I<br />
<strong>and</strong> II <strong>and</strong> Oxford <strong>and</strong> compared to published data from 47 infected individuals<br />
at USMMVP [6], for a total of 175 volunteers. Individuals were generally 20-40<br />
years old, with equal distribution between male <strong>and</strong> female participants (Table<br />
1). There were no significant differences in sex distribution between the<br />
different cohorts (Kruskal-Wallis, p=0.22), but RUNMC II volunteers were<br />
significantly younger (Kruskal-Wallis, p37.5°C) occurred with significant higher frequency in<br />
RUNMC <strong>and</strong> USMMVP.<br />
105
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