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
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Safety <strong>and</strong> Immunogenicity of a Recombinant Plasmodium falciparum AMA1<br />
Malaria vaccine Adjuvanted with Alhydrogel TM, Montanide ISA 720 or AS02<br />
falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J<br />
Infect Dis 1995; 171:1576-1585.<br />
25. Sun P, Schwenk R, White K, Stoute JA, Cohen J et al. Protective immunity induced<br />
with malaria vaccine, RTS,S, is linked to Plasmodium falciparum circumsporozoite<br />
protein-specific CD4+ <strong>and</strong> CD8+ T cells producing IFN-gamma. J Immunol 2003;<br />
171:6961-6967.<br />
26. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE et al. A preliminary<br />
evaluation of a recombinant circumsporozoite protein vaccine <strong>against</strong><br />
Plasmodium falciparum malaria. RTS,S Malaria Vaccine Evaluation Group. N Engl J<br />
Med 1997; 336:86-91.<br />
27. Kocken CH, Withers-Martinez C, Dubbeld MA, Van Der WA, Hackett F et al. Highlevel<br />
expression of the malaria blood-stage vaccine c<strong>and</strong>idate Plasmodium<br />
falciparum apical membrane antigen 1 <strong>and</strong> induction of antibodies that inhibit<br />
erythrocyte invasion. Infect Immun 2002; 70:4471-4476.<br />
28. Faber BW, Remarque EJ, Kocken CH, Cheront P, Cingolani D et al. Production,<br />
quality control, stability <strong>and</strong> pharmacotoxicity of cGMP-produced Plasmodium<br />
falciparum AMA1 FVO strain ectodomain expressed in Pichia pastoris. Vaccine<br />
2008; 26:6143-6150.<br />
29. 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 />
30. Human D, Crawley F, IJesselmuiden C. Revised declaration of Helsinki. WMA will<br />
continue to revise policy as medicine <strong>and</strong> research changes. BMJ 2001; 323:283-<br />
284.<br />
31. Hermsen CC, Verhage DF, Telgt DS, Teelen K, Bousema JT et al. Glutamate-rich<br />
protein (GLURP) induces antibodies that inhibit in vitro growth of Plasmodium<br />
falciparum in a phase 1 malaria vaccine trial. Vaccine 2007; 25:2930-2940.<br />
32. Zepp F, Knuf M, Habermehl P, Mannhardt-Laakmann W, Howe B et al. Safety of<br />
reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in<br />
adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. J<br />
Pediatr 2006; 149:603-610.<br />
33. Kshirsagar N, Mur N, Thatte U, Gogtay N, Viviani S et al. Safety, immunogenicity,<br />
<strong>and</strong> antibody persistence of a new meningococcal group A conjugate vaccine in<br />
healthy Indian adults. Vaccine 2007; 25 suppl1:A101-A107<br />
34. Malkin E, Long CA, Stowers AW, Zou L, Singh S et al. Phase 1 Study of Two<br />
Merozoite Surface Protein 1 (MSP1(42)) Vaccines for Plasmodium falciparum<br />
Malaria. PLoS Clin Trials 2007; 2:e12.<br />
55