Experimental infection and protection against ... - TI Pharma

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Induction of malaria in volunteers by intradermal injection of cryopreserved Plasmodium falciparum sporozoites Matheny, Yingda Wen, Keith Nelson, James Overby, Virak Pich, Thomas Mitchell; Dissection: Richard Fan; Purification: Lixin Gao, Ray Xu; Formulation and Cryopreservation: Adam Ruben, Aderonke Awe, Quality Assurance and Quality Control: Irina Belyakova, Mary King; Assays: Chinnamma Chakiath; Rana Chattopadhyay, Charles Anderson, Solomon Conteh, Gwynne Roth; Regulatory and Clinical Affairs: Tooba Murshedkar. We are grateful for Sanaria’s Operations and Legal teams, especially Robert Thompson, Alexander Hoffman, and David Dolberg. We thank the entire Protein Potential Team including, Adriana Ahumada, Maria Socorro Orozco, Bing Jiang, Emily Chen. We also thank MSource (Belgium, now CromSource, Italy) for clinical monitoring. Funding Manufacturing of PfSPZ Challenge and this clinical trial were funded by TIPharma, grant number T4-102. ACT is funded by the European Malaria Vaccine Development Association, KNM was funded by a Mozaiek grant from the Netherlands Organisation for Scientific Research. The development and manufacturing of PfSPZ Challenge was also supported by Small Business Innovation Research (SBIR) grants R44AI058375-03,04,05,05S1 from NIAID/NIH and through Agreement 07984 from the PATH Malaria Vaccine Initiative. 165
166 Chapter 8 References 1. World Malaria Report, 2011. (http://www.who.int/malaria) 2. Murray CJ, Rosenfeld LC, Lim SS, et al. Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet 2012; 379:413-431. 3. Najera JA, Gonzalez-Silva M, Alonso PL. Some lessons for the future from the Global Malaria Eradication Programme (1955-1969). PLoS Med 2011; 8:e1000412. 4. Sauerwein RW, Roestenberg M, Moorthy VS. Experimental human challenge infections can accelerate clinical malaria vaccine development. Nat Rev Immunol 2011; 11:57-64. 5. Covell G, Nicol WD. Clinical, chemotherapeutic and immunological studies on induced malaria. Br Med Bull 1951; 8:51-5. 6. Coggeshall LT & Craige B Old and new plasmodicides. Malariology: a comprehensive survey of all aspects of this group of diseases from a global standpoint, ed Boyd MF (W. B. Saunders, Philadelphia), 1949; Vol II:1071-1114. 7. Alving AS, Arnold J, Hockwald RS, et al. Potentiation of the curative action of primaquine in vivax malaria by quinine and chloroquine. J. Lab. Clin. Med. 1955; 46:301-306. 8. Shapiro TA, Ranasinha CD, Kumar N, & Barditch-Crovo P Prophylactic activity of atovaquone against Plasmodium falciparum in humans. Am. J. Trop. Med. Hyg. 1999; 60:831-836. 9. Ifediba T, Vanderberg JP. Complete in vitro maturation of Plasmodium falciparum gametocytes. Nature 1981; 294:364-6. 10. Campbell CC, Collins WE, Nguyen Dinh P, Barber A, Broderson JR. Plasmodium falciparum gametocytes from culture in vitro develop to sporozoites that are infectious to primates. Science 1982; 217:1048-50. 11. Chulay JD, Schneider I, Cosgriff TM, et al. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am J Trop Med Hyg 1986;35:66-8. 12. Gordon DM, McGovern TW, Krzych U, et al. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J Infect Dis 1995; 171:1576- 85. 13. Stoute JA, Slaoui M, Heppner DG, et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N Engl J Med 1997; 336:86-91.
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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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Page 207 and 208: 206 Chapter 10 temperature (Pearson
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Chapter 11 General Discussion
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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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