Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites

Summary

It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.

Timeline

Start

2012-06

Primary completion

2015-05

Completion

2017-09

Publications

• Background Wang R, Arevalo-Herrera M, Gardner MJ, Bonelo A, Carlton JM, Gomez A, Vera O, Soto L, Vergara J, Bidwell SL, Domingo A, Fraser CM, Herrera S. Immune responses to Plasmodium vivax pre-erythrocytic stage antigens in naturally exposed Duffy-negative humans: a potential model for identification of liver-stage antigens. Eur J Immunol. 2005 Jun;35(6):1859-68. doi: 10.1002/eji.200425807.
• Background Coban C, Ishii KJ, Horii T, Akira S. Manipulation of host innate immune responses by the malaria parasite. Trends Microbiol. 2007 Jun;15(6):271-8. doi: 10.1016/j.tim.2007.04.003. Epub 2007 Apr 26.
• Background Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
• Background Richie TL, Saul A. Progress and challenges for malaria vaccines. Nature. 2002 Feb 7;415(6872):694-701. doi: 10.1038/415694a.
• Background Doolan DL, Hoffman SL, Southwood S, Wentworth PA, Sidney J, Chesnut RW, Keogh E, Appella E, Nutman TB, Lal AA, Gordon DM, Oloo A, Sette A. Degenerate cytotoxic T cell epitopes from P. falciparum restricted by multiple HLA-A and HLA-B supertype alleles. Immunity. 1997 Jul;7(1):97-112. doi: 10.1016/s1074-7613(00)80513-0.
• Background Mellouk S, Lunel F, Sedegah M, Beaudoin RL, Druilhe P. Protection against malaria induced by irradiated sporozoites. Lancet. 1990 Mar 24;335(8691):721. doi: 10.1016/0140-6736(90)90832-p. No abstract available.
• Background Nussenzweig R, Vanderberg J, Most H. Protective immunity produced by the injection of x-irradiated sporozoites of Plasmodium berghei. IV. Dose response, specificity and humoral immunity. Mil Med. 1969 Sep;134(10):1176-82. No abstract available.
• Background Seguin MC, Klotz FW, Schneider I, Weir JP, Goodbary M, Slayter M, Raney JJ, Aniagolu JU, Green SJ. Induction of nitric oxide synthase protects against malaria in mice exposed to irradiated Plasmodium berghei infected mosquitoes: involvement of interferon gamma and CD8+ T cells. J Exp Med. 1994 Jul 1;180(1):353-8. doi: 10.1084/jem.180.1.353.
• Background Weiss WR. Host-parasite interactions and immunity to irradiated sporozoites. Immunol Lett. 1990 Aug;25(1-3):39-42. doi: 10.1016/0165-2478(90)90088-8.
• Background Weiss WR, Sedegah M, Beaudoin RL, Miller LH, Good MF. CD8+ T cells (cytotoxic/suppressors) are required for protection in mice immunized with malaria sporozoites. Proc Natl Acad Sci U S A. 1988 Jan;85(2):573-6. doi: 10.1073/pnas.85.2.573.
• Background Collins WE, Contacos PG. Immunization of monkeys against Plasmodium cynomolgi by X-irradiated sporozoites. Nat New Biol. 1972 Apr 12;236(67):176-7. doi: 10.1038/newbio236176a0. No abstract available.
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• Background Egan JE, Hoffman SL, Haynes JD, Sadoff JC, Schneider I, Grau GE, Hollingdale MR, Ballou WR, Gordon DM. Humoral immune responses in volunteers immunized with irradiated Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 1993 Aug;49(2):166-73. doi: 10.4269/ajtmh.1993.49.166.
• Background Clyde DF. Immunity to falciparum and vivax malaria induced by irradiated sporozoites: a review of the University of Maryland studies, 1971-75. Bull World Health Organ. 1990;68 Suppl(Suppl):9-12.
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• Background Clyde DF, Most H, McCarthy VC, Vanderberg JP. Immunization of man against sporozite-induced falciparum malaria. Am J Med Sci. 1973 Sep;266(3):169-77. doi: 10.1097/00000441-197309000-00002. No abstract available.
• Background Clyde DF. Immunization of man against falciparum and vivax malaria by use of attenuated sporozoites. Am J Trop Med Hyg. 1975 May;24(3):397-401. doi: 10.4269/ajtmh.1975.24.397.
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• Background Herrington D, Davis J, Nardin E, Beier M, Cortese J, Eddy H, Losonsky G, Hollingdale M, Sztein M, Levine M, et al. Successful immunization of humans with irradiated malaria sporozoites: humoral and cellular responses of the protected individuals. Am J Trop Med Hyg. 1991 Nov;45(5):539-47. doi: 10.4269/ajtmh.1991.45.539.
• Background Krzych U, Lyon JA, Jareed T, Schneider I, Hollingdale MR, Gordon DM, Ballou WR. T lymphocytes from volunteers immunized with irradiated Plasmodium falciparum sporozoites recognize liver and blood stage malaria antigens. J Immunol. 1995 Oct 15;155(8):4072-7.
• Background Glynn JR. Infecting dose and severity of malaria: a literature review of induced malaria. J Trop Med Hyg. 1994 Oct;97(5):300-16.
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• Background Chulay JD, Schneider I, Cosgriff TM, Hoffman SL, Ballou WR, Quakyi IA, Carter R, Trosper JH, Hockmeyer WT. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am J Trop Med Hyg. 1986 Jan;35(1):66-8. doi: 10.4269/ajtmh.1986.35.66.
• Background Bejon P, Andrews L, Andersen RF, Dunachie S, Webster D, Walther M, Gilbert SC, Peto T, Hill AV. Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. J Infect Dis. 2005 Feb 15;191(4):619-26. doi: 10.1086/427243. Epub 2005 Jan 7.
• Background van Dijk MR, Douradinha B, Franke-Fayard B, Heussler V, van Dooren MW, van Schaijk B, van Gemert GJ, Sauerwein RW, Mota MM, Waters AP, Janse CJ. Genetically attenuated, P36p-deficient malarial sporozoites induce protective immunity and apoptosis of infected liver cells. Proc Natl Acad Sci U S A. 2005 Aug 23;102(34):12194-9. doi: 10.1073/pnas.0500925102. Epub 2005 Aug 15.
• Background Hurtado S, Salas ML, Romero JF, Zapata JC, Ortiz H, Arevalo-Herrera M, Herrera S. Regular production of infective sporozoites of Plasmodium falciparum and P. vivax in laboratory-bred Anopheles albimanus. Ann Trop Med Parasitol. 1997 Jan;91(1):49-60. doi: 10.1080/00034983.1997.11813111.
• Background Zapata JC, Perlaza BL, Hurtado S, Quintero GE, Jurado D, Gonzalez I, Druilhe P, Arevalo-Herrera M, Herrera S. Reproducible infection of intact Aotus lemurinus griseimembra monkeys by Plasmodium falciparum sporozoite inoculation. J Parasitol. 2002 Aug;88(4):723-9. doi: 10.1645/0022-3395(2002)088[0723:RIOIAL]2.0.CO;2.
• Background Herrera, S., et al., Development of a sporozoite challenge model for Plasmodium vivax in human volunteers. . (Submitte), 2009
• Background Herrera, S., et al., Implication of Plasmdium vivax sporozoite challenge system in vaccine development, in International Research in Infectious Diseases. 2007. p. 53.
• Background Herrera S, De Plata C, Gonzalez M, Perlaza BL, Bettens F, Corradin G, Arevalo-Herrera M. Antigenicity and immunogenicity of multiple antigen peptides (MAP) containing P. vivax CS epitopes in Aotus monkeys. Parasite Immunol. 1997 Apr;19(4):161-70. doi: 10.1046/j.1365-3024.1997.d01-193.x.
• Background Herrera S, Bonelo A, Perlaza BL, Valencia AZ, Cifuentes C, Hurtado S, Quintero G, Lopez JA, Corradin G, Arevalo-Herrera M. Use of long synthetic peptides to study the antigenicity and immunogenicity of the Plasmodium vivax circumsporozoite protein. Int J Parasitol. 2004 Dec;34(13-14):1535-46. doi: 10.1016/j.ijpara.2004.10.009.
• Background Jordan-Villegas, A., et al., Cellular and humoral responses to Plasmodium vivax irradiated sporozoites in Aotus monkeys. (In preparation), 2007
• Background Hollingdale MR, Krzych U. Immune responses to liver-stage parasites: implications for vaccine development. Chem Immunol. 2002;80:97-124. doi: 10.1159/000058841. No abstract available.
• Background Yoshida N, Nussenzweig RS, Potocnjak P, Nussenzweig V, Aikawa M. Hybridoma produces protective antibodies directed against the sporozoite stage of malaria parasite. Science. 1980 Jan 4;207(4426):71-3. doi: 10.1126/science.6985745.
• Background Hollingdale MR, Nardin EH, Tharavanij S, Schwartz AL, Nussenzweig RS. Inhibition of entry of Plasmodium falciparum and P. vivax sporozoites into cultured cells; an in vitro assay of protective antibodies. J Immunol. 1984 Feb;132(2):909-13.
• Background Millet P, Chizzolini C, Pieniazek NJ, Charoenvit Y, Nakamura K, Aikawa M, Jones TR, Hoffman SL, Collins WE. A monoclonal antibody directed against the sporozoite stage of Plasmodium vivax binds to liver parenchymal cells. Immunol Lett. 1992 Aug;33(3):289-94. doi: 10.1016/0165-2478(92)90075-y.
• Background Romero P, Maryanski JL, Corradin G, Nussenzweig RS, Nussenzweig V, Zavala F. Cloned cytotoxic T cells recognize an epitope in the circumsporozoite protein and protect against malaria. Nature. 1989 Sep 28;341(6240):323-6. doi: 10.1038/341323a0.
• Background Tsuji M, Romero P, Nussenzweig RS, Zavala F. CD4+ cytolytic T cell clone confers protection against murine malaria. J Exp Med. 1990 Nov 1;172(5):1353-7. doi: 10.1084/jem.172.5.1353.
• Background Tsuji M, Mombaerts P, Lefrancois L, Nussenzweig RS, Zavala F, Tonegawa S. Gamma delta T cells contribute to immunity against the liver stages of malaria in alpha beta T-cell-deficient mice. Proc Natl Acad Sci U S A. 1994 Jan 4;91(1):345-9. doi: 10.1073/pnas.91.1.345.
• Background Renggli J, Hahne M, Matile H, Betschart B, Tschopp J, Corradin G. Elimination of P. berghei liver stages is independent of Fas (CD95/Apo-I) or perforin-mediated cytotoxicity. Parasite Immunol. 1997 Mar;19(3):145-8. doi: 10.1046/j.1365-3024.1997.d01-190.x.
• Background Calvo-Calle JM, Hammer J, Sinigaglia F, Clavijo P, Moya-Castro ZR, Nardin EH. Binding of malaria T cell epitopes to DR and DQ molecules in vitro correlates with immunogenicity in vivo: identification of a universal T cell epitope in the Plasmodium falciparum circumsporozoite protein. J Immunol. 1997 Aug 1;159(3):1362-73.
• Background Ferreira A, Schofield L, Enea V, Schellekens H, van der Meide P, Collins WE, Nussenzweig RS, Nussenzweig V. Inhibition of development of exoerythrocytic forms of malaria parasites by gamma-interferon. Science. 1986 May 16;232(4752):881-4. doi: 10.1126/science.3085218.
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• Background Weiss WR, Berzofsky JA, Houghten RA, Sedegah M, Hollindale M, Hoffman SL. A T cell clone directed at the circumsporozoite protein which protects mice against both Plasmodium yoelii and Plasmodium berghei. J Immunol. 1992 Sep 15;149(6):2103-9.
• Background Sedegah M, Finkelman F, Hoffman SL. Interleukin 12 induction of interferon gamma-dependent protection against malaria. Proc Natl Acad Sci U S A. 1994 Oct 25;91(22):10700-2. doi: 10.1073/pnas.91.22.10700.
• Background Hoffman SL, Crutcher JM, Puri SK, Ansari AA, Villinger F, Franke ED, Singh PP, Finkelman F, Gately MK, Dutta GP, Sedegah M. Sterile protection of monkeys against malaria after administration of interleukin-12. Nat Med. 1997 Jan;3(1):80-3. doi: 10.1038/nm0197-80.
• Background Fidock DA, Gras-Masse H, Lepers JP, Brahimi K, Benmohamed L, Mellouk S, Guerin-Marchand C, Londono A, Raharimalala L, Meis JF, et al. Plasmodium falciparum liver stage antigen-1 is well conserved and contains potent B and T cell determinants. J Immunol. 1994 Jul 1;153(1):190-204.
• Background Good MF, Pombo D, Quakyi IA, Riley EM, Houghten RA, Menon A, Alling DW, Berzofsky JA, Miller LH. Human T-cell recognition of the circumsporozoite protein of Plasmodium falciparum: immunodominant T-cell domains map to the polymorphic regions of the molecule. Proc Natl Acad Sci U S A. 1988 Feb;85(4):1199-203. doi: 10.1073/pnas.85.4.1199.
• Background Guebre-Xabier M, Schwenk R, Krzych U. Memory phenotype CD8(+) T cells persist in livers of mice protected against malaria by immunization with attenuated Plasmodium berghei sporozoites. Eur J Immunol. 1999 Dec;29(12):3978-86. doi: 10.1002/(SICI)1521-4141(199912)29:123.0.CO;2-0.
• Background López, J.A., et al., Immunogenicity of synthetic peptides corresponding to the nonrepeat regions of the P. falciparum circumsporozoite protein. Vaccines 96. Cold Spring Harbor Laboratory 1996: p. 255-260
• Background Perlaza BL, Arevalo-Herrera M, Brahimi K, Quintero G, Palomino JC, Gras-Masse H, Tartar A, Druilhe P, Herrera S. Immunogenicity of four Plasmodium falciparum preerythrocytic antigens in Aotus lemurinus monkeys. Infect Immun. 1998 Jul;66(7):3423-8. doi: 10.1128/IAI.66.7.3423-3428.1998.
• Background Perlaza BL, Zapata C, Valencia AZ, Hurtado S, Quintero G, Sauzet JP, Brahimi K, Blanc C, Arevalo-Herrera M, Druilhe P, Herrera S. Immunogenicity and protective efficacy of Plasmodium falciparum liver-stage Ag-3 in Aotus lemurinus griseimembra monkeys. Eur J Immunol. 2003 May;33(5):1321-7. doi: 10.1002/eji.200323339.
• Background Herrera S, Herrera MA, Certa U, Corredor A, Guerrero R. Efficiency of human Plasmodium falciparum malaria vaccine candidates in Aotus lemurinus monkeys. Mem Inst Oswaldo Cruz. 1992;87 Suppl 3:423-8. doi: 10.1590/s0074-02761992000700071.
• Background Valderrama-Aguirre A, Quintero G, Gomez A, Castellanos A, Perez Y, Mendez F, Arevalo-Herrera M, Herrera S. Antigenicity, immunogenicity, and protective efficacy of Plasmodium vivax MSP1 PV200l: a potential malaria vaccine subunit. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):16-24. doi: 10.4269/ajtmh.2005.73.16.
• Background Arevalo-Herrera M, Castellanos A, Yazdani SS, Shakri AR, Chitnis CE, Dominik R, Herrera S. Immunogenicity and protective efficacy of recombinant vaccine based on the receptor-binding domain of the Plasmodium vivax Duffy binding protein in Aotus monkeys. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):25-31. doi: 10.4269/ajtmh.2005.73.5_suppl.0730025.
• Background Jordan-Villegas A, Zapata JC, Perdomo AB, Quintero GE, Solarte Y, Arevalo-Herrera M, Herrera S. Aotus lemurinus griseimembra monkeys: a suitable model for Plasmodium vivax sporozoite infection. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):10-5. doi: 10.4269/ajtmh.2005.73.10.
• Background Herrera S, Bonelo A, Perlaza BL, Fernandez OL, Victoria L, Lenis AM, Soto L, Hurtado H, Acuna LM, Velez JD, Palacios R, Chen-Mok M, Corradin G, Arevalo-Herrera M. Safety and elicitation of humoral and cellular responses in colombian malaria-naive volunteers by a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):3-9. doi: 10.4269/ajtmh.2005.73.3.
• Background Fernández, O., et al. Development of a sporozoite challenge model for Plasmodium vivax in human volunteers. in Annual meeting 54th American Society of Tropical Medicine and Hygiene. December 11-15. . 2005. Washington: Am Trop J Med. Hyg.
• Background Arevalo-Herrera M, Herrera S. Plasmodium vivax malaria vaccine development. Mol Immunol. 2001 Dec;38(6):443-55. doi: 10.1016/s0161-5890(01)00080-3.
• Background Castellanos A, Arevalo-Herrera M, Restrepo N, Gulloso L, Corradin G, Herrera S. Plasmodium vivax thrombospondin related adhesion protein: immunogenicity and protective efficacy in rodents and Aotus monkeys. Mem Inst Oswaldo Cruz. 2007 Jun;102(3):411-6. doi: 10.1590/s0074-02762007005000047.
• Background Rogers WO, Gowda K, Hoffman SL. Construction and immunogenicity of DNA vaccine plasmids encoding four Plasmodium vivax candidate vaccine antigens. Vaccine. 1999 Aug 6;17(23-24):3136-44. doi: 10.1016/s0264-410x(99)00146-2.
• Background Stowers AW, Cioce V, Shimp RL, Lawson M, Hui G, Muratova O, Kaslow DC, Robinson R, Long CA, Miller LH. Efficacy of two alternate vaccines based on Plasmodium falciparum merozoite surface protein 1 in an Aotus challenge trial. Infect Immun. 2001 Mar;69(3):1536-46. doi: 10.1128/IAI.69.3.1536-1546.2001.
• Background Collins WE, Kaslow DC, Sullivan JS, Morris CL, Galland GG, Yang C, Saekhou AM, Xiao L, Lal AA. Testing the efficacy of a recombinant merozoite surface protein (MSP-1(19) of Plasmodium vivax in Saimiri boliviensis monkeys. Am J Trop Med Hyg. 1999 Mar;60(3):350-6. doi: 10.4269/ajtmh.1999.60.350.
• Background Oliveira-Ferreira J, Vargas-Serrato E, Barnwell JW, Moreno A, Galinski MR. Immunogenicity of Plasmodium vivax merozoite surface protein-9 recombinant proteins expressed in E. coli. Vaccine. 2004 May 7;22(15-16):2023-30. doi: 10.1016/j.vaccine.2003.07.021.
• Background Yazdani SS, Shakri AR, Mukherjee P, Baniwal SK, Chitnis CE. Evaluation of immune responses elicited in mice against a recombinant malaria vaccine based on Plasmodium vivax Duffy binding protein. Vaccine. 2004 Sep 9;22(27-28):3727-37. doi: 10.1016/j.vaccine.2004.03.030.
• Background Kocken CH, Dubbeld MA, Van Der Wel A, Pronk JT, Waters AP, Langermans JA, Thomas AW. High-level expression of Plasmodium vivax apical membrane antigen 1 (AMA-1) in Pichia pastoris: strong immunogenicity in Macaca mulatta immunized with P. vivax AMA-1 and adjuvant SBAS2. Infect Immun. 1999 Jan;67(1):43-9. doi: 10.1128/IAI.67.1.43-49.1999.
• Background Malkin EM, Durbin AP, Diemert DJ, Sattabongkot J, Wu Y, Miura K, Long CA, Lambert L, Miles AP, Wang J, Stowers A, Miller LH, Saul A. Phase 1 vaccine trial of Pvs25H: a transmission blocking vaccine for Plasmodium vivax malaria. Vaccine. 2005 May 2;23(24):3131-8. doi: 10.1016/j.vaccine.2004.12.019.
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• Background Arevalo-Herrera M, Solarte Y, Zamora F, Mendez F, Yasnot MF, Rocha L, Long C, Miller LH, Herrera S. Plasmodium vivax: transmission-blocking immunity in a malaria-endemic area of Colombia. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):38-43. doi: 10.4269/ajtmh.2005.73.5_suppl.0730038.
• Background Manzano, M.R., et al., Standardization of Anopheles albimanus infection with Plasmodium vivax for sporozoite challenge of naive volunteers. (In preparation), 2009.
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• Background Arevalo-Herrera M, Roggero MA, Gonzalez JM, Vergara J, Corradin G, Lopez JA, Herrera S. Mapping and comparison of the B-cell epitopes recognized on the Plasmodium vivax circumsporozoite protein by immune Colombians and immunized Aotus monkeys. Ann Trop Med Parasitol. 1998 Jul;92(5):539-51.
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• Background Arevalo-Herrera M, Valencia AZ, Vergara J, Bonelo A, Fleischhauer K, Gonzalez JM, Restrepo JC, Lopez JA, Valmori D, Corradin G, Herrera S. Identification of HLA-A2 restricted CD8(+) T-lymphocyte responses to Plasmodium vivax circumsporozoite protein in individuals naturally exposed to malaria. Parasite Immunol. 2002 Mar;24(3):161-9. doi: 10.1046/j.1365-3024.2002.00449.x.
• Background Perlaza BL, Sauzet JP, Balde AT, Brahimi K, Tall A, Corradin G, Druilhe P. Long synthetic peptides encompassing the Plasmodium falciparum LSA3 are the target of human B and T cells and are potent inducers of B helper, T helper and cytolytic T cell responses in mice. Eur J Immunol. 2001 Jul;31(7):2200-9. doi: 10.1002/1521-4141(200107)31:73.0.co;2-l.
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• Background Herrera S, Gomez A, Vera O, Vergara J, Valderrama-Aguirre A, Maestre A, Mendez F, Wang R, Chitnis CE, Yazdani SS, Arevalo-Herrera M. Antibody response to Plasmodium vivax antigens in Fy-negative individuals from the Colombian Pacific coast. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):44-9. doi: 10.4269/ajtmh.2005.73.44.
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