Experimental infection and protection against ... - TI Pharma

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Induction of malaria in volunteers by intradermal injection of cryopreserved Plasmodium falciparum sporozoites Supplementary Data Time point Potency (# of parasites expressing PfMSP-1/well) % Viability (sporozoite membrane integrity assay) Fresh 27 ± 4.6 ND* Release 20 ± 1.7 83.3% ± 6.5% 6 Month 18 ± 2.1 86.6% ± 1.9% 9 Month 20 ± 2.1 83.7% ± 8.4% 12 Month 21 ± 1.5 84.8% ± 3.0% 18 Month 20 ± 0.6 83.7% ± 4.2% 24 Month 18 ± 1.0 86.0% ± 1.5% Pre-1st clinical dose (26 Month) 17 ± 0.6 79.4% ± 6.5% Post-last clinical dose (30 Month) 16 ± 2.6 87.4% ± 1.9% Table S1. Results of potency and sporozoite membrane integrity assays on the lot of PfSPZ * Not done Date Status of PySPZ Viability (SMIA) Number of PySPZ Inoculated (IV) ID50 (Number of PySPZ) Oct 2009 fresh 96.3% 24-12-6-3 8.9 Dec 2009 cryopreserved 72.7% 200-100-50-25 33.1 Dec 2009 cryopreserved 68.3% 200-100-50-25 62.1 Jan 2010 cryopreserved 67.7% 400-200-100-50-25 103.8 Feb 2010 cryopreserved 67.1% 400-200-100-50-25 55.2 Feb 2010 cryopreserved 71.6% 400-200-100-50-25 107 Feb 2010 cryopreserved 73.9% 400-200-100-50-25 34.5 Mean cryopreserved 70.2% 66.0 Difference between fresh and cryopreserved PySPZ 26.1% 7.4-fold Table S2. Effect of cryopreservation on sporozoite membrane integrity and infectivity in mice inoculated intravenously with the same lot of P. yoelii sporozoites. Infectivity was the number of sporozoites required to infect 50% of BALB/c mice. 169
170 Chapter 8 Before Purification (14 x 10 6 PfSPZ/ml) After Purification (1.6 x 10 6 PfSPZ/ml) Figure S1. PfSPZ before and after purification. Photomicrograph (200 x) of the PfSPZ in the lot of PfSPZ Challenge used in the clinical trial prior to purification and after purification. The purification process reduced the amount of salivary gland material in the PfSPZ samples by greater than 99.9%. Figure S2: Clinical trial profile
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Experimental infection and protecti
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Experimental infection and protecti
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Contents Contents 5 Chapter 1 - Int
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Introduction 9 Malaria Malaria is o
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Introduction 11 Preclinical Clinica
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Introduction 13 pipeline of clinica
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Introduction 15 The division of ant
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Introduction 17 Figure 4. Populatio
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Introduction 19 candidates. Initial
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Introduction 21 - to identify param
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Introduction 23 20. Nussenzweig RS,
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Introduction 25 50. Ouedraogo AL, R
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Introduction 27 RTS,S/AS02 in malar
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Chapter 2 Safety and Immunogenicity
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Safety and Immunogenicity of a Reco
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Chapter 3 Humoral immune responses
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Humoral immune responses to a singl
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Chapter 4 82 Abstract The functiona
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84 Chapter 4 Figure 1. Schematic re
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86 Chapter 4 Concentration (mg/ml,
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88 Chapter 4 Figure 4: Correlation
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90 Chapter 4 positively correlated
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92 Chapter 4 Acknowledgements The a
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94 Chapter 4 determinant of subsequ
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Chapter 5 Comparison of clinical an
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Comparison of clinical and parasito
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Chapter 6 Efficacy of pre-erythrocy
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Page 154 and 155: Induction of malaria in volunteers
Page 172: Section 3 Whole parasite inoculatio
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Page 177 and 178: 176 Chapter 9 Figure 1. Study desig
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Page 181 and 182: 180 Chapter 9 Figure 2. Parasitemia
Page 183 and 184: 182 Chapter 9 Test Day I-1 Day C-1
Page 185 and 186: 184 Chapter 9 strain P. falciparum-
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Page 189 and 190: 188 Chapter 9 References 1. Greenwo
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Page 193 and 194: 192 Chapter 9 medium A (Caltag Labo
Page 195 and 196: 194 Chapter 10 Abstract Induction o
Page 197 and 198: 196 Chapter 10 Pre-erythrocytic sta
Page 199 and 200: 198 Chapter 10 procedures described
Page 201 and 202: 200 Chapter 10 by hand-dissection.
Page 203 and 204: 202 Chapter 10 Figure 3. Mean numbe
Page 205 and 206: 204 Chapter 10 Figure 4. Number of
Page 207 and 208: 206 Chapter 10 temperature (Pearson
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Page 211 and 212: 210 Chapter 10 cytokine measurement
Page 213 and 214: 212 Chapter 10 14. Hermsen CC, Telg
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Page 218 and 219: General Discussion 217 occurrence o
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General Discussion 219 mediating th
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General Discussion 221 AMA1 express
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General Discussion 223 troponins ca
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General Discussion 225 and between
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General Discussion 227 immunologica
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General Discussion 229 to induce pr
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General Discussion 231 Conclusions
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General Discussion 233 References 1
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General Discussion 235 polymorphonu
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General Discussion 237 57. Church L
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General Discussion 239 85. Beier JC
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General Discussion 241 118. Mueller
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Chapter 12 Summary Samenvatting Lis
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246 Chapter 12 Controlled human mal
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Summary, Samenvatting, List of publ
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254 Chapter 12 Roestenberg M, Teirl
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