Experimental infection and protection against ... - TI Pharma
Experimental infection and protection against ... - TI Pharma Experimental infection and protection against ... - TI Pharma
Safety and Immunogenicity of a Recombinant Plasmodium falciparum AMA1 Malaria vaccine Adjuvanted with Alhydrogel TM, Montanide ISA 720 or AS02 falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J Infect Dis 1995; 171:1576-1585. 25. Sun P, Schwenk R, White K, Stoute JA, Cohen J et al. Protective immunity induced with malaria vaccine, RTS,S, is linked to Plasmodium falciparum circumsporozoite protein-specific CD4+ and CD8+ T cells producing IFN-gamma. J Immunol 2003; 171:6961-6967. 26. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. RTS,S Malaria Vaccine Evaluation Group. N Engl J Med 1997; 336:86-91. 27. Kocken CH, Withers-Martinez C, Dubbeld MA, Van Der WA, Hackett F et al. Highlevel expression of the malaria blood-stage vaccine candidate Plasmodium falciparum apical membrane antigen 1 and induction of antibodies that inhibit erythrocyte invasion. Infect Immun 2002; 70:4471-4476. 28. Faber BW, Remarque EJ, Kocken CH, Cheront P, Cingolani D et al. Production, quality control, stability and pharmacotoxicity of cGMP-produced Plasmodium falciparum AMA1 FVO strain ectodomain expressed in Pichia pastoris. Vaccine 2008; 26:6143-6150. 29. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Jr. et al. A phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naive adults. Vaccine 2007; 25:5359-5366. 30. Human D, Crawley F, IJesselmuiden C. Revised declaration of Helsinki. WMA will continue to revise policy as medicine and research changes. BMJ 2001; 323:283- 284. 31. Hermsen CC, Verhage DF, Telgt DS, Teelen K, Bousema JT et al. Glutamate-rich protein (GLURP) induces antibodies that inhibit in vitro growth of Plasmodium falciparum in a phase 1 malaria vaccine trial. Vaccine 2007; 25:2930-2940. 32. Zepp F, Knuf M, Habermehl P, Mannhardt-Laakmann W, Howe B et al. Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. J Pediatr 2006; 149:603-610. 33. Kshirsagar N, Mur N, Thatte U, Gogtay N, Viviani S et al. Safety, immunogenicity, and antibody persistence of a new meningococcal group A conjugate vaccine in healthy Indian adults. Vaccine 2007; 25 suppl1:A101-A107 34. Malkin E, Long CA, Stowers AW, Zou L, Singh S et al. Phase 1 Study of Two Merozoite Surface Protein 1 (MSP1(42)) Vaccines for Plasmodium falciparum Malaria. PLoS Clin Trials 2007; 2:e12. 55
56 Chapter 2 35. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Jr. et al. A phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naive adults. Vaccine 2007; 25:5359-5366. 36. Polhemus ME, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF et al. Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naive adults at the Walter Reed Army Institute of Research. Vaccine 2007; 25:4203- 4212. 37. Vandepapeliere P, Rehermann B, Koutsoukos M, Moris P, Garcon N et al. Potent enhancement of cellular and humoral immune responses against recombinant hepatitis B antigens using AS02A adjuvant in healthy adults. Vaccine 2005; 23:2591-2601. 38. Langermans JA, Schmidt A, Vervenne RA, Birkett AJ, Calvo-Calle JM et al. Effect of adjuvant on reactogenicity and long-term immunogenicity of the malaria Vaccine ICC-1132 in macaques. Vaccine 2005; 23:4935-4943. 39. Langermans JA, Hensmann M, van GM, Zhang D, Pan W et al. Preclinical evaluation of a chimeric malaria vaccine candidate in Montanide ISA 720: immunogenicity and safety in rhesus macaques. Hum Vaccin 2006; 2:222-226. 40. Toledo H, Baly A, Castro O, Resik S, Laferte J et al. A phase I clinical trial of a multiepitope polypeptide TAB9 combined with Montanide ISA 720 adjuvant in non-HIV- 1 infected human volunteers. Vaccine 2001; 19:4328-4336. 41. Miles AP, McClellan HA, Rausch KM, Zhu D, Whitmore MD et al. Montanide ISA 720 vaccines: quality control of emulsions, stability of formulated antigens, and comparative immunogenicity of vaccine formulations. Vaccine 2005; 23:2530- 2539. 42. Saul A, Lawrence G, Allworth A, Elliott S, Anderson K et al. A human phase 1 vaccine clinical trial of the Plasmodium falciparum malaria vaccine candidate apical membrane antigen 1 in Montanide ISA720 adjuvant. Vaccine 2005; 23:3076-3083. 43. Ulanova M, Tarkowski A, Hahn-Zoric M, Hanson LA The Common vaccine adjuvant aluminum hydroxide up-regulates accessory properties of human monocytes via an interleukin-4-dependent mechanism. Infect Immun 2001; 69:1151-1159.
- Page 6: Contents Contents 5 Chapter 1 - Int
- Page 10 and 11: Introduction 9 Malaria Malaria is o
- Page 12 and 13: Introduction 11 Preclinical Clinica
- Page 14 and 15: Introduction 13 pipeline of clinica
- Page 16 and 17: Introduction 15 The division of ant
- Page 18 and 19: Introduction 17 Figure 4. Populatio
- Page 20 and 21: Introduction 19 candidates. Initial
- Page 22 and 23: Introduction 21 - to identify param
- Page 24 and 25: Introduction 23 20. Nussenzweig RS,
- Page 26 and 27: Introduction 25 50. Ouedraogo AL, R
- Page 28: Introduction 27 RTS,S/AS02 in malar
- Page 32 and 33: Chapter 2 Safety and Immunogenicity
- Page 34 and 35: Safety and Immunogenicity of a Reco
- Page 36 and 37: Safety and Immunogenicity of a Reco
- Page 38 and 39: Safety and Immunogenicity of a Reco
- Page 40 and 41: Safety and Immunogenicity of a Reco
- Page 42 and 43: Safety and Immunogenicity of a Reco
- Page 44 and 45: Safety and Immunogenicity of a Reco
- Page 46 and 47: Safety and Immunogenicity of a Reco
- Page 48 and 49: Safety and Immunogenicity of a Reco
- Page 50 and 51: Safety and Immunogenicity of a Reco
- Page 52 and 53: Safety and Immunogenicity of a Reco
- Page 54 and 55: Safety and Immunogenicity of a Reco
- Page 58 and 59: Chapter 3 Humoral immune responses
- Page 60 and 61: Humoral immune responses to a singl
- Page 62 and 63: Humoral immune responses to a singl
- Page 64 and 65: Humoral immune responses to a singl
- Page 66 and 67: Humoral immune responses to a singl
- Page 68 and 69: Humoral immune responses to a singl
- Page 70 and 71: Humoral immune responses to a singl
- Page 72 and 73: Humoral immune responses to a singl
- Page 74 and 75: Humoral immune responses to a singl
- Page 76 and 77: Humoral immune responses to a singl
- Page 78 and 79: Humoral immune responses to a singl
- Page 80: Humoral immune responses to a singl
- Page 83 and 84: Chapter 4 82 Abstract The functiona
- Page 85 and 86: 84 Chapter 4 Figure 1. Schematic re
- Page 87 and 88: 86 Chapter 4 Concentration (mg/ml,
- Page 89 and 90: 88 Chapter 4 Figure 4: Correlation
- Page 91 and 92: 90 Chapter 4 positively correlated
- Page 93 and 94: 92 Chapter 4 Acknowledgements The a
- Page 95 and 96: 94 Chapter 4 determinant of subsequ
- Page 98 and 99: Chapter 5 Comparison of clinical an
- Page 100 and 101: Comparison of clinical and parasito
- Page 102 and 103: Comparison of clinical and parasito
- Page 104 and 105: Comparison of clinical and parasito
56 Chapter 2<br />
35. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Jr. et al. A<br />
phase I/IIa safety, immunogenicity, <strong>and</strong> efficacy bridging r<strong>and</strong>omized study of a<br />
two-dose regimen of liquid <strong>and</strong> lyophilized formulations of the c<strong>and</strong>idate malaria<br />
vaccine RTS,S/AS02A in malaria-naive adults. Vaccine 2007; 25:5359-5366.<br />
36. Polhemus ME, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF et al. Phase I<br />
dose escalation safety <strong>and</strong> immunogenicity trial of Plasmodium falciparum apical<br />
membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naive<br />
adults at the Walter Reed Army Institute of Research. Vaccine 2007; 25:4203-<br />
4212.<br />
37. V<strong>and</strong>epapeliere P, Rehermann B, Koutsoukos M, Moris P, Garcon N et al. Potent<br />
enhancement of cellular <strong>and</strong> humoral immune responses <strong>against</strong> recombinant<br />
hepatitis B antigens using AS02A adjuvant in healthy adults. Vaccine 2005;<br />
23:2591-2601.<br />
38. Langermans JA, Schmidt A, Vervenne RA, Birkett AJ, Calvo-Calle JM et al. Effect of<br />
adjuvant on reactogenicity <strong>and</strong> long-term immunogenicity of the malaria Vaccine<br />
ICC-1132 in macaques. Vaccine 2005; 23:4935-4943.<br />
39. Langermans JA, Hensmann M, van GM, Zhang D, Pan W et al. Preclinical<br />
evaluation of a chimeric malaria vaccine c<strong>and</strong>idate in Montanide ISA 720:<br />
immunogenicity <strong>and</strong> safety in rhesus macaques. Hum Vaccin 2006; 2:222-226.<br />
40. Toledo H, Baly A, Castro O, Resik S, Laferte J et al. A phase I clinical trial of a multiepitope<br />
polypeptide TAB9 combined with Montanide ISA 720 adjuvant in non-HIV-<br />
1 infected human volunteers. Vaccine 2001; 19:4328-4336.<br />
41. Miles AP, McClellan HA, Rausch KM, Zhu D, Whitmore MD et al. Montanide ISA<br />
720 vaccines: quality control of emulsions, stability of formulated antigens, <strong>and</strong><br />
comparative immunogenicity of vaccine formulations. Vaccine 2005; 23:2530-<br />
2539.<br />
42. Saul A, Lawrence G, Allworth A, Elliott S, Anderson K et al. A human phase 1<br />
vaccine clinical trial of the Plasmodium falciparum malaria vaccine c<strong>and</strong>idate<br />
apical membrane antigen 1 in Montanide ISA720 adjuvant. Vaccine 2005;<br />
23:3076-3083.<br />
43. Ulanova M, Tarkowski A, Hahn-Zoric M, Hanson LA The Common vaccine adjuvant<br />
aluminum hydroxide up-regulates accessory properties of human monocytes via<br />
an interleukin-4-dependent mechanism. Infect Immun 2001; 69:1151-1159.
Change language