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 References 1. Girard MP, Reed ZH, Friede M, Kieny MP. A review of human vaccine research and development: malaria. Vaccine 2007; 25:1567-1580. 2. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E et al. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet 2005; 366:2012-2018. 3. Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q et al. Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 2007; 370:1543-1551. 4. Mitchell GH, Thomas AW, Margos G, Dluzewski AR, Bannister LH. Apical membrane antigen 1, a major malaria vaccine candidate, mediates the close attachment of invasive merozoites to host red blood cells. Infect Immun 2004; 72:154-158. 5. Hodder AN, Crewther PE, Anders RF. Specificity of the protective antibody response to apical membrane antigen 1. Infect Immun 2001; 69:3286-3294. 6. Silvie O, Franetich JF, Charrin S, Mueller MS, Siau A et al. A role for apical membrane antigen 1 during invasion of hepatocytes by Plasmodium falciparum sporozoites. J Biol Chem 2004; 279:9490-9496. 7. Howell SA, Withers-Martinez C, Kocken CH, Thomas AW, Blackman MJ. Proteolytic processing and primary structure of Plasmodium falciparum apical membrane antigen-1. J Biol Chem 2001; 276: 31311-31320. 8. Remarque EJ, Faber BW, Kocken CH, Thomas AW. Apical membrane antigen 1: a malaria vaccine candidate in review. Trends Parasitol 2008; 24:74-84. 9. Ockenhouse CF, Sun PF, Lanar DE, Wellde BT, Hall BT et al. Phase I/IIa safety, immunogenicity, and efficacy trial of NYVAC-Pf7, a pox-vectored, multiantigen, multistage vaccine candidate for Plasmodium falciparum malaria. J Infect Dis 1998; 177:1664-1673. 10. Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP et al. Phase 1 clinical trial of apical membrane antigen 1: an asexual blood-stage vaccine for Plasmodium falciparum malaria. Infect Immun 2005; 73:3677-3685. 11. Schijns VE, Degen WG. Vaccine immunopotentiators of the future. Clin Pharmacol Ther 2007; 82:750-755. 12. Keitel WA, Kester KE, Atmar RL, White AC, Bond NH et al. Phase I trial of two recombinant vaccines containing the 19kd carboxy terminal fragment of Plasmodium falciparum merozoite surface protein 1 (msp-1(19)) and T helper epitopes of tetanus toxoid. Vaccine 1999; 18:531-539. 53
54 Chapter 2 13. Ballou WR, Hoffman SL, Sherwood JA, Hollingdale MR, Neva FA et al. Safety and efficacy of a recombinant DNA Plasmodium falciparum sporozoite vaccine. Lancet 1987; 1:1277-1281. 14. Amador R, Moreno A, Valero V, Murillo L, Mora AL et al. The first field trials of the chemically synthesized malaria vaccine SPf66: safety, immunogenicity and protectivity. Vaccine 1992; 10:179-184. 15. Lawrence G, Cheng QQ, Reed C, Taylor D, Stowers A et al. Effect of vaccination with 3 recombinant asexual-stage malaria antigens on initial growth rates of Plasmodium falciparum in non-immune volunteers. Vaccine 2000; 18:1925-1931. 16. Lawrence GW, Saul A, Giddy AJ, Kemp R, Pye D. Phase I trial in humans of an oilbased adjuvant SEPPIC Montanide ISA 720. Vaccine 1997; 15:176-178. 17. Saul A, Lawrence G, Smillie A, Rzepczyk CM, Reed C et al. Human phase I vaccine trials of 3 recombinant asexual stage malaria antigens with Montanide ISA720 adjuvant. Vaccine 1999; 17:3145-3159. 18. Genton B, Betuela I, Felger I, Al-Yaman F, Anders RF et al. A recombinant bloodstage malaria vaccine reduces Plasmodium falciparum density and exerts selective pressure on parasite populations in a phase 1-2b trial in Papua New Guinea. J Infect Dis 2002; 185:820-827. 19. Aucouturier J, Dupuis L, Deville S, Ascarateil S, Ganne V. Montanide ISA 720 and 51: a new generation of water in oil emulsions as adjuvants for human vaccines. Expert Rev Vaccines 2002; 1:111-118. 20. Heppner DG, Jr., Kester KE, Ockenhouse CF, Tornieporth N, Ofori O et al. Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research. Vaccine 2005; 23:2243- 2250. 21. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E et al. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet 2005; 366:2012-2018. 22. Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q et al. Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 2007; 370:1543-1551. 23. Bojang KA, Milligan PJ, Pinder M, Vigneron L, Alloueche A et al. Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semiimmune adult men in The Gambia: a randomised trial. Lancet 2001; 358:1927- 1934. 24. Gordon DM, McGovern TW, Krzych U, Cohen JC, Schneider I et al. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium
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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 />
References<br />
1. Girard MP, Reed ZH, Friede M, Kieny MP. A review of human vaccine research <strong>and</strong><br />
development: malaria. Vaccine 2007; 25:1567-1580.<br />
2. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E et al. Duration of <strong>protection</strong><br />
with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum<br />
disease in Mozambican children: single-blind extended follow-up of a r<strong>and</strong>omised<br />
controlled trial. Lancet 2005; 366:2012-2018.<br />
3. Aponte JJ, Aide P, Renom M, M<strong>and</strong>om<strong>and</strong>o I, Bassat Q et al. Safety of the<br />
RTS,S/AS02D c<strong>and</strong>idate malaria vaccine in infants living in a highly endemic area of<br />
Mozambique: a double blind r<strong>and</strong>omised controlled phase I/IIb trial. Lancet 2007;<br />
370:1543-1551.<br />
4. Mitchell GH, Thomas AW, Margos G, Dluzewski AR, Bannister LH. Apical<br />
membrane antigen 1, a major malaria vaccine c<strong>and</strong>idate, mediates the close<br />
attachment of invasive merozoites to host red blood cells. Infect Immun 2004;<br />
72:154-158.<br />
5. Hodder AN, Crewther PE, Anders RF. Specificity of the protective antibody<br />
response to apical membrane antigen 1. Infect Immun 2001; 69:3286-3294.<br />
6. Silvie O, Franetich JF, Charrin S, Mueller MS, Siau A et al. A role for apical<br />
membrane antigen 1 during invasion of hepatocytes by Plasmodium falciparum<br />
sporozoites. J Biol Chem 2004; 279:9490-9496.<br />
7. Howell SA, Withers-Martinez C, Kocken CH, Thomas AW, Blackman MJ. Proteolytic<br />
processing <strong>and</strong> primary structure of Plasmodium falciparum apical membrane<br />
antigen-1. J Biol Chem 2001; 276: 31311-31320.<br />
8. Remarque EJ, Faber BW, Kocken CH, Thomas AW. Apical membrane antigen 1: a<br />
malaria vaccine c<strong>and</strong>idate in review. Trends Parasitol 2008; 24:74-84.<br />
9. Ockenhouse CF, Sun PF, Lanar DE, Wellde BT, Hall BT et al. Phase I/IIa safety,<br />
immunogenicity, <strong>and</strong> efficacy trial of NYVAC-Pf7, a pox-vectored, multiantigen,<br />
multistage vaccine c<strong>and</strong>idate for Plasmodium falciparum malaria. J Infect Dis<br />
1998; 177:1664-1673.<br />
10. Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP et al. Phase 1 clinical<br />
trial of apical membrane antigen 1: an asexual blood-stage vaccine for<br />
Plasmodium falciparum malaria. Infect Immun 2005; 73:3677-3685.<br />
11. Schijns VE, Degen WG. Vaccine immunopotentiators of the future. Clin <strong>Pharma</strong>col<br />
Ther 2007; 82:750-755.<br />
12. Keitel WA, Kester KE, Atmar RL, White AC, Bond NH et al. Phase I trial of two<br />
recombinant vaccines containing the 19kd carboxy terminal fragment of<br />
Plasmodium falciparum merozoite surface protein 1 (msp-1(19)) <strong>and</strong> T helper<br />
epitopes of tetanus toxoid. Vaccine 1999; 18:531-539.<br />
53