Clinical trial NCT00367380 - References

ANEMIA — Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Citation(s)

•   11
  Bosman, A., Delacollette, C., Olumese, P., Ridley, RG., Rietveld, R., Shretta, R.,Teklehaimanot, A. The use of antimalarial drugs. Report of an Informal Consultation. Roll Back Malaria. WHO. 2001.
•   Arévalo-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.
•   Arévalo-Herrera M, Herrera S
  Plasmodium vivax malaria vaccine development. Mol Immunol. 2001 Dec;38(6):443-55. Review.
•   Arévalo-Herrera M, Roggero MA, Gonzalez JM, Vergara J, Corradin G, López 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.
•   Arévalo-Herrera M, Solarte Y, Yasnot MF, Castellanos A, Rincón A, Saul A, Mu J, Long C, Miller L, Herrera S
  Induction of transmission-blocking immunity in Aotus monkeys by vaccination with a Plasmodium vivax clinical grade PVS25 recombinant protein. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):32-7.
•   Arévalo-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.
•   Baird JK, Tiwari T, Martin GJ, Tamminga CL, Prout TM, Tjaden J, Bravet PP, Rawlins S, Ferrel M, Carucci D, Hoffman SL
  Chloroquine for the treatment of uncomplicated malaria in Guyana. Ann Trop Med Parasitol. 2002 Jun;96(4):339-48.
•   Ballou WR, Arevalo-Herrera M, Carucci D, Richie TL, Corradin G, Diggs C, Druilhe P, Giersing BK, Saul A, Heppner DG, Kester KE, Lanar DE, Lyon J, Hill AV, Pan W, Cohen JD
  Update on the clinical development of candidate malaria vaccines. Am J Trop Med Hyg. 2004 Aug;71(2 Suppl):239-47. Review.
•   Baton LA, Ranford-Cartwright LC
  How do malaria ookinetes cross the mosquito midgut wall? Trends Parasitol. 2005 Jan;21(1):22-8. Review.
•   Blair S, López ML, Piñeros JG, Alvarez T, Tobón A, Carmona J
  [Therapeutic efficacy of 3 treatment protocols for non-complicated Plasmodium falciparum malaria, Antioquia, Colombia, 2002]. Biomedica. 2003 Sep;23(3):318-27. Spanish.
•   Blow JA, Turell MJ, Walker ED, Silverman AL
  Post-bloodmeal diuretic shedding of hepatitis B virus by mosquitoes (Diptera: Culicidae). J Med Entomol. 2002 Jul;39(4):605-12.
•   Chappel JA, Rogers WO, Hoffman SL, Kang AS
  Molecular dissection of the human antibody response to the structural repeat epitope of Plasmodium falciparum sporozoite from a protected donor. Malar J. 2004 Jul 29;3:28.
•   Chauhan VS, Bhardwaj D
  Current status of malaria vaccine development. Adv Biochem Eng Biotechnol. 2003;84:143-82. Review.
•   Chotivanich K, Silamut K, Udomsangpetch R, Stepniewska KA, Pukrittayakamee S, Looareesuwan S, White NJ
  Ex-vivo short-term culture and developmental assessment of Plasmodium vivax. Trans R Soc Trop Med Hyg. 2001 Nov-Dec;95(6):677-80.
•   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.
•   Church LW, Le TP, Bryan JP, Gordon DM, Edelman R, Fries L, Davis JR, Herrington DA, Clyde DF, Shmuklarsky MJ, Schneider I, McGovern TW, Chulay JD, Ballou WR, Hoffman SL
  Clinical manifestations of Plasmodium falciparum malaria experimentally induced by mosquito challenge. J Infect Dis. 1997 Apr;175(4):915-20.
•   Clyde DF, McCarthy VC, Miller RM, Hornick RB
  Specificity of protection of man immunized against sporozoite-induced falciparum malaria. Am J Med Sci. 1973 Dec;266(6):398-403.
•   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:9-12. Review.
•   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.
•   Cogswell FB
  The hypnozoite and relapse in primate malaria. Clin Microbiol Rev. 1992 Jan;5(1):26-35. Review.
•   Collins WE, Jeffery GM
  Primaquine resistance in Plasmodium vivax. Am J Trop Med Hyg. 1996 Sep;55(3):243-9. Review.
•   Danis M
  [Therapeutic advances against malaria in 2003]. Med Trop (Mars). 2003;63(3):267-70. Review. French.
•   Doolan DL, Hoffman SL
  Nucleic acid vaccines against malaria. Chem Immunol. 2002;80:308-21. Review.
•   Duarte EC, Pang LW, Ribeiro LC, Fontes CJ
  Association of subtherapeutic dosages of a standard drug regimen with failures in preventing relapses of vivax malaria. Am J Trop Med Hyg. 2001 Nov;65(5):471-6.
•   Edelman R, Hoffman SL, Davis JR, Beier M, Sztein MB, Losonsky G, Herrington DA, Eddy HA, Hollingdale MR, Gordon DM, et al
  Long-term persistence of sterile immunity in a volunteer immunized with X-irradiated Plasmodium falciparum sporozoites. J Infect Dis. 1993 Oct;168(4):1066-70.
•   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.
•   FAIRLEY NH
  Sidelights on malaria in man obtained by subinoculation experiments. Trans R Soc Trop Med Hyg. 1947 May;40(5):621-76.
•   Fernández, O
  ,Manzano, M.R, Murrain, B., Blanco P., Zamora F., Jordan, A. Palacios, R., Velez, D., Arevalo-Herrera, M., Herrera, S. Development of a sporozoite challenge model for Plasmodium vivax in human volunteers. ASTMH. Annual Metting 54th. 2005.
•   Fryauff DJ, Baird JK, Basri H, Sumawinata I, Purnomo, Richie TL, Ohrt CK, Mouzin E, Church CJ, Richards AL, et al
  Randomised placebo-controlled trial of primaquine for prophylaxis of falciparum and vivax malaria. Lancet. 1995 Nov 4;346(8984):1190-3.
•   Genton B, Corradin G
  Malaria vaccines: from the laboratory to the field. Curr Drug Targets Immune Endocr Metabol Disord. 2002 Oct;2(3):255-67. Review.
•   George FW 4th, Law JL, Rich KA, Martin WJ
  Identification of a T-cell epitope on the circumsporozoite protein of Plasmodium vivax. Infect Immun. 1990 Feb;58(2):575-8.
•   Glynn JR, Bradley DJ
  Inoculum size, incubation period and severity of malaria. Analysis of data from malaria therapy records. Parasitology. 1995 Jan;110 ( Pt 1):7-19.
•   Glynn JR, Collins WE, Jeffery GM, Bradley DJ
  Infecting dose and severity of falciparum malaria. Trans R Soc Trop Med Hyg. 1995 May-Jun;89(3):281-3.
•   Glynn JR
  Infecting dose and severity of malaria: a literature review of induced malaria. J Trop Med Hyg. 1994 Oct;97(5):300-16. Review.
•   Golenda CF, Li J, Rosenberg R
  Continuous in vitro propagation of the malaria parasite Plasmodium vivax. Proc Natl Acad Sci U S A. 1997 Jun 24;94(13):6786-91.
•   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.
•   Grassi, B
  , Bignami, A., Bastianelli, G. Ulteriori ricerche sul ciclo dei parassiti malarici umani nel corpo del zanzarone. Atti Reale Accademia dei Lincei. 1899.5:8-21.
•   Hermsen CC, de Vlas SJ, van Gemert GJ, Telgt DS, Verhage DF, Sauerwein RW
  Testing vaccines in human experimental malaria: statistical analysis of parasitemia measured by a quantitative real-time polymerase chain reaction. Am J Trop Med Hyg. 2004 Aug;71(2):196-201.
•   Herrera MA, de Plata C, González JM, Corradin G, Herrera S
  Immunogenicity of multiple antigen peptides containing Plasmodium vivax CS epitopes in BALB/c mice. Mem Inst Oswaldo Cruz. 1994;89 Suppl 2:71-6.
•   Herrera S, Bonelo A, Perlaza BL, Fernández OL, Victoria L, Lenis AM, Soto L, Hurtado H, Acuña LM, Vélez JD, Palacios R, Chen-Mok M, Corradin G, Arévalo-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.
•   Herrera S, De Plata C, González M, Perlaza BL, Bettens F, Corradin G, Arévalo-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.
•   Herrera S, Escobar P, de Plata C, Avila GI, Corradin G, Herrera MA
  Human recognition of T cell epitopes on the Plasmodium vivax circumsporozoite protein. J Immunol. 1992 Jun 15;148(12):3986-90.
•   Herrera S, Perlaza BL, Bonelo A, Arévalo-Herrera M
  Aotus monkeys: their great value for anti-malaria vaccines and drug testing. Int J Parasitol. 2002 Dec 4;32(13):1625-35. Review.
•   Herrera, S
  , Manzano, M., Fernandez, O., Solarte, Y., Rocha, L., Vergara, J., Bermans, M., Acuña, L., Londoño, C., Palacios, R., Rincon, A., Yansot, MF., Arevalo-Herrera, M. Establishment of a sporozoite challenge model for Plasmodium vivax in human volunteers. 2006b. Manuscrito en preparación.
•   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.
•   Hisaeda H, Yasutomo K
  Development of malaria vaccines that block transmission of parasites by mosquito vectors. J Med Invest. 2002 Aug;49(3-4):118-23. Review.
•   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. Epub 2002 Apr 1.
•   Hoffman SL
  Experimental challenge of volunteers with malaria. Ann Intern Med. 1997 Aug 1;127(3):233-5.
•   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.
•   Jordan, A
  , Cellular and humoral response of P vivax irradiated sporozoites in Aotus monkeys. Am. J. Trop. Med Hyg., 2006 .Manuscrito en preparación.
•   Krotoski WA
  The hypnozoite and malarial relapse. Prog Clin Parasitol. 1989;1:1-19. Review.
•   Luke TC, Hoffman SL
  Rationale and plans for developing a non-replicating, metabolically active, radiation-attenuated Plasmodium falciparum sporozoite vaccine. J Exp Biol. 2003 Nov;206(Pt 21):3803-8. Review.
•   Manzano, M
  R, Rocha, L., Hurtado, Solarte, Y., Arévalo-Herrera, M., Herrera, S., Development of a sporozoite challenge model of naïve voluntieers using Anopheles albimanus infected with Plasmodium vivax. 2006. Manuscrito en preparación.
•   McCarthy VC, Clyde DF
  Plasmodium vivax: correlation of circumsporozoite precipitation (CSP) reaction with sporozoite-induced protective immunity in man. Exp Parasitol. 1977 Feb;41(1):167-71.
•   McGready R, Thwai KL, Cho T, Samuel, Looareesuwan S, White NJ, Nosten F
  The effects of quinine and chloroquine antimalarial treatments in the first trimester of pregnancy. Trans R Soc Trop Med Hyg. 2002 Mar-Apr;96(2):180-4.
•   MCGREGOR IA, GILLES HM, WALTERS JH, DAVIES AH, PEARSON FA
  Effects of heavy and repeated malarial infections on Gambian infants and children; effects of erythrocytic parasitization. Br Med J. 1956 Sep 22;2(4994):686-92.
•   Meis JF, Ponnudurai T, Mons B, van Belkum A, van Eerd PM, Druilhe P, Schellekens H
  Plasmodium falciparum: studies on mature exoerythrocytic forms in the liver of the chimpanzee, Pan troglodytes. Exp Parasitol. 1990 Jan;70(1):1-11.
•   Mendis K, Sina BJ, Marchesini P, Carter R
  The neglected burden of Plasmodium vivax malaria. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):97-106. Review.
•   Ministerio de la Protección Social
  República de Colombia. 2005. http://www.minproteccionsocial.gov.co/MseContent/images/news/DocNewsNo603701.pdf
•   Ministerio de Salud, Republica de Colombia
  2000. Guía de atención de la malariahttp://www.metrosalud.gov.co/Paginas/Protocolos/MinSalud/guias/31-MALARIA.htm.
•   Nardin E, Clavijo P, Mons B, van Belkum A, Ponnudurai T, Nussenzweig RS
  T cell epitopes of the circumsporozoite protein of Plasmodium vivax. Recognition by lymphocytes of a sporozoite-immunized chimpanzee. J Immunol. 1991 Mar 1;146(5):1674-8.
•   NCI
  ,NIH., DCTD., DHHS. Common Terminology Criteria for Adverse Events v3.0. 2003. http://ctep.cancer.gov/forms/CTCAEv3.pdf
•   Nosten F, McGready R, Simpson JA, Thwai KL, Balkan S, Cho T, Hkirijaroen L, Looareesuwan S, White NJ
  Effects of Plasmodium vivax malaria in pregnancy. Lancet. 1999 Aug 14;354(9178):546-9.
•   OMS
  2005. World Malaria Report 2005. Prepared by Roll Back Malaria, WHO and Unicef. http://www.rbm.who.int/wmr2005/pdf/WMReport_lr.pdf.
•   Padilla, JC
  , Guhl, F., Soto, J., Alvarez, G. Diagnóstico y terapéutica de las enfermedades transmitidas por vectores en Colombia.1999, v.2500. p.128
•   Perlaza BL, Zapata C, Valencia AZ, Hurtado S, Quintero G, Sauzet JP, Brahimi K, Blanc C, Arévalo-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.
•   Phillips-Howard PA
  Epidemiological and control issues related to malaria in pregnancy. Ann Trop Med Parasitol. 1999 Dec;93 Suppl 1:S11-7.
•   Powell RD, McNamara JV
  Infection with chloroquine-resistant Plasmodium falciparum in man: prepatent periods, incubation periods, and relationships between parasitemia and the onset of fever in nonimmune persons. Ann N Y Acad Sci. 1970 Oct 30;174(2):1027-41.
•   Rieckmann KH, Beaudoin RL, Cassells JS, Sell KW
  Use of attenuated sporozoites in the immunization of human volunteers against falciparum malaria. Bull World Health Organ. 1979;57 Suppl 1:261-5.
•   Rieckmann KH
  Human immunization with attenuated sporozoites. Bull World Health Organ. 1990;68 Suppl:13-6.
•   Safety and immunogenecity of a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine in two Montanide ISA formulations
  2006a. Manuscrito en preparacion.
•   Salas ML, Romero JF, Solarte Y, Olano V, Herrera MA, Herrera S
  Development of sporogonic cycle of Plasmodium vivax in experimentally infected Anopheles albimanus mosquitoes. Mem Inst Oswaldo Cruz. 1994;89 Suppl 2:115-9.
•   Singh N, Shukla MM, Sharma VP
  Epidemiology of malaria in pregnancy in central India. Bull World Health Organ. 1999;77(7):567-72.
•   Snounou G, Viriyakosol S, Jarra W, Thaithong S, Brown KN
  Identification of the four human malaria parasite species in field samples by the polymerase chain reaction and detection of a high prevalence of mixed infections. Mol Biochem Parasitol. 1993 Apr;58(2):283-92.
•   Soto J, Toledo J, Gutierrez P, Luzz M, Llinas N, Cedeño N, Dunne M, Berman J
  Plasmodium vivax clinically resistant to chloroquine in Colombia. Am J Trop Med Hyg. 2001 Aug;65(2):90-3.
•   Talisuna AO, Bloland P, D'Alessandro U
  History, dynamics, and public health importance of malaria parasite resistance. Clin Microbiol Rev. 2004 Jan;17(1):235-54. Review.
•   Trigg, PI
  , and Kondrachine, AV. 1998. The current global malaria situation, p. 11-22. In I. Sherman (ed.), Malaria: Parasite biology, pathogenesis and protection. AMS Press, Washington DC.
•   Valderrama-Aguirre A, Quintero G, Gómez A, Castellanos A, Pérez Y, Méndez F, Arévalo-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.
•   Walther M, Dunachie S, Keating S, Vuola JM, Berthoud T, Schmidt A, Maier C, Andrews L, Andersen RF, Gilbert S, Poulton I, Webster D, Dubovsky F, Tierney E, Sarpotdar P, Correa S, Huntcooke A, Butcher G, Williams J, Sinden RE, Thornton GB, Hill AV
  Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720. Vaccine. 2005 Jan 4;23(7):857-64.
•   Wilairatana P, Krudsood S, Treeprasertsuk S, Chalermrut K, Looareesuwan S
  The future outlook of antimalarial drugs and recent work on the treatment of malaria. Arch Med Res. 2002 Jul-Aug;33(4):416-21.
•   Yagmur Y, Kara IH, Aldemir M, Büyükbayram H, Tacyildiz IH, Keles C
  Spontaneous rupture of malarial spleen: two case reports and review of literature. Crit Care. 2000;4(5):309-13. Epub 2000 Aug 10. Review.
•   Zapata JC, Perlaza BL, Hurtado S, Quintero GE, Jurado D, González I, Druilhe P, Arévalo-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.

Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Details for clinical trial NCT00367380