The development and clinical evaluation of second-generation leishmaniasis vaccines

Vaccine

Volumn 30, Issue 2, 2012, Pages 134-141

  Duthie, Malcolm S ^a   Raman, Vanitha S ^a   Piazza, Franco M ^a   Reed, Steven G ^a  

^a INFECTIOUS DISEASE RESEARCH INSTITUTE   (United States)

Author keywords

Leishmania; Protozoa; T cell; TLR; Vaccine

Indexed keywords

ALLOPURINOL; AMPHOTERICIN B; AMPHOTERICIN B LIPID COMPLEX; ANTIMONY DERIVATIVE; BCG VACCINE; FUCOSE MANNOSE LIGAND VACCINE; GAMMA INTERFERON; GLYCOPROTEIN LEISHMANIOLYSIN; INDUCIBLE NITRIC OXIDE SYNTHASE; INTERLEUKIN 2; LEISH 111F VACCINE; LEISHMANIA VACCINE; LEISHMUNE; MEGLUMINE ANTIMONATE; MILTEFOSINE; NITRIC OXIDE; PHOSPHORYL LIPID A; PLASMID DNA; RECOMBINANT PROTEIN; STIBOGLUCONATE SODIUM; TOLL LIKE RECEPTOR AGONIST; UNCLASSIFIED DRUG;

CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; DOG; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; HUMAN; IMMUNE RESPONSE; IMMUNITY; LEISHMANIA; LEISHMANIASIS; LEISHMANIN SKIN TEST; MACROPHAGE; MAJOR HISTOCOMPATIBILITY COMPLEX; NONHUMAN; PASSIVE IMMUNIZATION; PRIORITY JOURNAL; RESERVOIR; REVIEW; SIGNAL TRANSDUCTION; T LYMPHOCYTE; VACCINATION;

ANIMALS; CLINICAL TRIALS AS TOPIC; DISEASE RESERVOIRS; DOG DISEASES; DOGS; HUMANS; INCIDENCE; LEISHMANIASIS; LEISHMANIASIS VACCINES; WORLD HEALTH;

EID: 84355162776     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.11.005     Document Type: Review

References (99)

1. Scientific working group on Leishmaniasis. Meeting report. 2-4 February 2004, Geneva, Switzerland. 2004. http://apps.who.int/tdr/publications/tdr-research-publications/swg-report-leishmaniasis/pdf/swg_leish.pdf.
2. WHO, Control of the Leishmanises, in WHO Technical Report Series 2010, World Health Organization: Geneva.
3. The Center for Food Security and Public Health, I.S.U., Leishmaniasis (cutaneous & visceral). Animal Disease Resource Index. Factsheets; 2009.
4. Gelanew T., et al. Inference of population structure of Leishmania donovani strains isolated from different Ethiopian visceral leishmaniasis endemic areas. PLoS Negl Trop Dis 2010, 4(11):p. e889.
5. Zerpa O., et al. Canine visceral leishmaniasis on Margarita Island (Nueva Esparta, Venezuela). Trans R Soc Trop Med Hyg 2000, 94(5):484-487.
6. Oliveira L.F., et al. Systematic review of the adverse effects of cutaneous leishmaniasis treatment in the New World. Acta Trop 2011, 118(2):87-96.
7. Sundar S., et al. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 2001, 323(7310):419-422.
8. Sundar S., et al. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 2002, 66(2):143-146.
9. Sundar S., et al. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis 2004, 38(3):377-383.
10. Matlashewski G., et al. Visceral leishmaniasis: elimination with existing interventions. Lancet Infect Dis 2011, 11(4):322-325.
11. Sundar S., et al. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 2010, 362(6):504-512.
12. Scott P., et al. Role of cytokines and CD4+ T-cell subsets in the regulation of parasite immunity and disease. Immunol Rev 1989, 112:161-182.
13. Sypek J.P., et al. Resolution of cutaneous leishmaniasis: interleukin 12 initiates a protective T helper type 1 immune response. J Exp Med 1993, 177(6):1797-1802.
14. Heinzel F.P., et al. Recombinant interleukin 12 cures mice infected with Leishmania major. J Exp Med 1993, 177(5):1505-1509.
15. Sacks D.L., Melby P.C. Animal models for the analysis of immune responses to leishmaniasis. Curr Protoc Immunol 2001, Chapter 19: Unit 19.2.
16. Melby P.C., et al. The hamster as a model of human visceral leishmaniasis: progressive disease and impaired generation of nitric oxide in the face of a prominent Th1-like cytokine response. J Immunol 2001, 166(3):1912-1920.
17. Badaro R., et al. Successful use of a defined antigen/GM-CSF adjuvant vaccine to treat mucosal Leishmaniasis refractory to antimony: a case report. Braz J Infect Dis 2001, 5(4):223-232.
18. Khalil E.A., et al. Autoclaved Leishmania major vaccine for prevention of visceral leishmaniasis: a randomised, double-blind, BCG-controlled trial in Sudan. Lancet 2000, 356(9241):1565-1569.
19. Momeni A.Z., et al. A randomised, double-blind, controlled trial of a killed L. major vaccine plus BCG against zoonotic cutaneous leishmaniasis in Iran. Vaccine 1999, 17(5):466-472.
20. Armijos R.X., et al. Field trial of a vaccine against New World cutaneous leishmaniasis in an at-risk child population: safety, immunogenicity, and efficacy during the first 12 months of follow-up. J Infect Dis 1998, 177(5):1352-1357.
21. Bahar K., et al. Comparative safety and immunogenicity trial of two killed Leishmania major vaccines with or without BCG in human volunteers. Clin Dermatol 1996, 14(5):489-495.
22. Sharifi I., et al. Randomised vaccine trial of single dose of killed Leishmania major plus BCG against anthroponotic cutaneous leishmaniasis in Bam, Iran. Lancet 1998, 351(9115):1540-1543.
23. Velez I.D., et al. Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia. Trans R Soc Trop Med Hyg 2005, 99(8):593-598.
24. Armijos R.X., et al. Field trial of a vaccine against new world cutaneous leishmaniasis in an at-risk child population: how long does protection last?. J Infect Dis 2003, 187(12):1959-1961.
25. Noazin S., et al. Efficacy of killed whole-parasite vaccines in the prevention of leishmaniasis: a meta-analysis. Vaccine 2009, 27(35):4747-4753.
26. Mayrink W., et al. Immunotherapy, immunochemotherapy and chemotherapy for American cutaneous leishmaniasis treatment. Rev Soc Bras Med Trop 2006, 39(1):14-21.
27. Convit J., et al. Immunotherapy versus chemotherapy in localised cutaneous leishmaniasis. Lancet 1987, 1(8530):401-405.
28. Genaro O., et al. Vaccine for prophylaxis and immunotherapy, Brazil. Clin Dermatol 1996, 14(5):503-512.
29. Mohebali M., et al. Double-blind randomized efficacy field trial of alum precipitated autoclaved Leishmania major vaccine mixed with BCG against canine visceral leishmaniasis in Meshkin-Shahr district, I. R. Iran. Vaccine 2004, 22(29-30):4097-4100.
30. Reed S.G., et al. New horizons in adjuvants for vaccine development. Trends Immunol 2009, 30(1):23-32.
31. Duthie M.S., et al. Use of defined TLR ligands as adjuvants within human vaccines. Immunol Rev 2011, 239(1):178-196.
32. Rafati S., et al. Protective vaccination against experimental canine visceral leishmaniasis using a combination of DNA and protein immunization with cysteine proteinases type I and II of L. infantum. Vaccine 2005, 23(28):3716-3725.
33. Soong L., et al. Leishmania pifanoi amastigote antigens protect mice against cutaneous leishmaniasis. Infect Immun 1995, 63(9):3559-3566.
34. Basu R., et al. Kinetoplastid membrane protein-11 DNA vaccination induces complete protection against both pentavalent antimonial-sensitive and -resistant strains of Leishmania donovani that correlates with inducible nitric oxide synthase activity and IL-4 generation: evidence for mixed Th1- and Th2-like responses in visceral leishmaniasis. J Immunol 2005, 174(11):7160-7171.
35. Streit J.A., et al. BCG expressing LCR1 of Leishmania chagasi induces protective immunity in susceptible mice. Exp Parasitol 2000, 94(1):33-41.
36. Stager S., Smith D.F., Kaye P.M. Immunization with a recombinant stage-regulated surface protein from Leishmania donovani induces protection against visceral leishmaniasis. J Immunol 2000, 165(12):7064-7071.
37. Tewary P., et al. A heterologous prime-boost vaccination regimen using ORFF DNA and recombinant ORFF protein confers protective immunity against experimental visceral leishmaniasis. J Infect Dis 2005, 191(12):2130-2137.
38. Iborra S., et al. The Leishmania infantum acidic ribosomal protein P0 administered as a DNA vaccine confers protective immunity to Leishmania major infection in BALB/c mice. Infect Immun 2003, 71(11):6562-6572.
39. Saravia N.G., et al. Protective immunogenicity of the paraflagellar rod protein 2 of Leishmania mexicana. Vaccine 2005, 23(8):984-995.
40. Aguilar-Be I., et al. Cross-protective efficacy of a prophylactic Leishmania donovani DNA vaccine against visceral and cutaneous murine leishmaniasis. Infect Immun 2005, 73(2):812-819.
41. Samant M., et al. Immunization with the DNA-encoding N-terminal domain of proteophosphoglycan of Leishmania donovani generates Th1-type immunoprotective response against experimental visceral leishmaniasis. J Immunol 2009, 183(1):470-479.
42. Russo D.M., et al. Human T cell responses to gp63, a surface antigen of Leishmania. J Immunol 1991, 147(10):3575-3580.
43. Burns J.M., et al. Characterization of a membrane antigen of Leishmania amazonensis that stimulates human immune responses. J Immunol 1991, 146(2):742-748.
44. McMahon-Pratt D., et al. Loss of the GP46/M-2 surface membrane glycoprotein gene family in the Leishmania braziliensis complex. Mol Biochem Parasitol 1992, 50(1):151-160.
45. Handman E., et al. Protective vaccination with promastigote surface antigen 2 from Leishmania major is mediated by a TH1 type of immune response. Infect Immun 1995, 63(11):4261-4267.
46. Sjolander A., et al. Vaccination with recombinant Parasite Surface Antigen 2 from Leishmania major induces a Th1 type of immune response but does not protect against infection. Vaccine 1998, 16(20):2077-2084.
47. Sjolander A., et al. Induction of a Th1 immune response and simultaneous lack of activation of a Th2 response are required for generation of immunity to leishmaniasis. J Immunol 1998, 160(8):3949-3957.
48. Handman E., et al. Therapy of murine cutaneous leishmaniasis by DNA vaccination. Vaccine 2000, 18(26):3011-3017.
49. Mougneau E., et al. Expression cloning of a protective Leishmania antigen. Science 1995, 268(5210):563-566.
50. Melby P.C., et al. Leishmania donovani p36(LACK) DNA vaccine is highly immunogenic but not protective against experimental visceral leishmaniasis. Infect Immun 2001, 69(8):4719-4725.
51. Garcon N., Van Mechelen M. Recent clinical experience with vaccines using MPL- and QS-21-containing adjuvant systems. Expert Rev Vaccines 2011, 10(4):471-486.
52. Skeiky Y.A., et al. Protective efficacy of a tandemly linked, multi-subunit recombinant leishmanial vaccine (Leish-111f) formulated in MPL adjuvant. Vaccine 2002, 20(27-28):3292-3303.
53. Coler R.N., et al. Leish-111f, a recombinant polyprotein vaccine that protects against visceral Leishmaniasis by elicitation of CD4+ T cells. Infect Immun 2007, 75(9):4648-4654.
54. Campos-Neto A., et al. Protection against cutaneous leishmaniasis induced by recombinant antigens in murine and nonhuman primate models of the human disease. Infect Immun 2001, 69(6):4103-4108.
55. Velez I.D., et al. Safety and immunogenicity of a defined vaccine for the prevention of cutaneous leishmaniasis. Vaccine 2009, 28(2):329-337.
56. Chakravarty J., et al. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine for use in the prevention of visceral leishmaniasis. Vaccine 2011, 29(19):3531-3537.
57. Nascimento E., et al. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis. Vaccine 2010, 28(40):6581-6587.
58. Badaro R., et al. Immunotherapy for drug-refractory mucosal leishmaniasis. J Infect Dis 2006, 194(8):1151-1159.
59. Llanos-Cuentas A., et al. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis. Vaccine 2010, 28(46):7427-7435.
60. Moreno J., Alvar J. Canine leishmaniasis: epidemiological risk and the experimental model. Trends Parasitol 2002, 18(9):399-405.
61. Noli C., Auxilia S.T. Treatment of canine Old World visceral leishmaniasis: a systematic review. Vet Dermatol 2005, 16(4):213-232.
62. Gradoni L., et al. Failure of a multi-subunit recombinant leishmanial vaccine (MML) to protect dogs from Leishmania infantum infection and to prevent disease progression in infected animals. Vaccine 2005, 23(45):5245-5251.
63. da Silva V.O., et al. A phase III trial of efficacy of the FML-vaccine against canine kala-azar in an endemic area of Brazil (Sao Goncalo do Amaranto RN). Vaccine 2000, 19(9-10):1082-1092.
64. Borja-Cabrera G.P., et al. Long lasting protection against canine kala-azar using the FML-QuilA saponin vaccine in an endemic area of Brazil (Sao Goncalo do Amarante RN). Vaccine 2002, 20(27-28):3277-3284.
65. Borja-Cabrera G.P., et al. Immunotherapy with the saponin enriched-Leishmune vaccine versus immunochemotherapy in dogs with natural canine visceral leishmaniasis. Vaccine 2010, 28(3):597-603.
66. Palatnik-de-Sousa C.B., et al. Decrease of the incidence of human and canine visceral leishmaniasis after dog vaccination with Leishmune in Brazilian endemic areas. Vaccine 2009, 27(27):3505-3512.
67. Trigo J., et al. Treatment of canine visceral leishmaniasis by the vaccine Leish-111f+MPL-SE. Vaccine 2010, 28(19):3333-3340.
68. Bertholet S., et al. Optimized subunit vaccine protects against experimental leishmaniasis. Vaccine 2009, 27(50):7036-7045.
69. Miret J., et al. Evaluation of an immunochemotherapeutic protocol constituted of N-methyl meglumine antimoniate (Glucantime) and the recombinant Leish-110f+MPL-SE vaccine to treat canine visceral leishmaniasis. Vaccine 2008, 26(12):1585-1594.
70. Nogueira F.S., et al. Leishmune vaccine blocks the transmission of canine visceral leishmaniasis: absence of Leishmania parasites in blood, skin and lymph nodes of vaccinated exposed dogs. Vaccine 2005, 23(40):4805-4810.
71. Raman V.S., et al. Applying TLR synergy in immunotherapy: implications in cutaneous leishmaniasis. J. Immunol. 2010, 185(3):1701-1710.
72. Darrah P.A., et al. Multifunctional TH1 cells define a correlate of vaccine-mediated protection against Leishmania major. Nat Med 2007, 13(7):843-850.
73. Goto Y., et al. Cloning, characterization, and serodiagnostic evaluation of Leishmania infantum tandem repeat proteins. Infect Immun 2006, 74(7):3939-3945.
74. Goto Y., et al. Protective immunization against visceral leishmaniasis using Leishmania sterol 24-c-methyltransferase formulated in adjuvant. Vaccine 2007, 25(42):7450-7458.
75. Goto Y., et al. Leishmania infantum sterol 24-c-methyltransferase formulated with MPL-SE induces cross-protection against L. major infection. Vaccine 2009, 27(21):2884-2890.
76. Mukhopadhyay S., et al. Immunoprophylaxis and immunotherapy against experimental visceral leishmaniasis. Vaccine 1999, 17(3):291-300.
77. Ghosh A., Zhang W.W., Matlashewski G. Immunization with A2 protein results in a mixed Th1/Th2 and a humoral response which protects mice against Leishmania donovani infections. Vaccine 2001, 20(1-2):59-66.
78. Rafati S., Zahedifard F., Nazgouee F. Prime-boost vaccination using cysteine proteinases type I and II of Leishmania infantum confers protective immunity in murine visceral leishmaniasis. Vaccine 2006, 24(12):2169-2175.
79. Fernandes A.P., et al. Protective immunity against challenge with Leishmania (Leishmania) chagasi in beagle dogs vaccinated with recombinant A2 protein. Vaccine 2008, 26(46):5888-5895.
80. Goto Y., et al. KSAC, the first defined polyprotein vaccine candidate for visceral leishmaniasis. Clin Vaccine Immunol: CVI 2011, 18(7):1118-1124.
81. Khamesipour A., et al. Leishmanization: use of an old method for evaluation of candidate vaccines against leishmaniasis. Vaccine 2005, 23(28):3642-3648.
82. Nylen S., et al. Surrogate markers of immunity to Leishmania major in leishmanin skin test negative individuals from an endemic area re-visited. Vaccine 2006, 24(47-48):6944-6954.
83. Singh S., et al. Diagnostic and prognostic value of K39 recombinant antigen in Indian leishmaniasis. J Parasitol 1995, 81(6):1000-1003.
84. Kumar R., et al. Enzyme-linked immunosorbent assay for recombinant K39 antigen in diagnosis and prognosis of Indian visceral leishmaniasis. Clin Diagn Lab Immunol 2001, 8(6):1220-1224.
85. Qu J.Q., et al. Serodiagnosis of Asian leishmaniasis with a recombinant antigen from the repetitive domain of a Leishmania kinesin. Trans R Soc Trop Med Hyg 1994, 88(5):543-545.
86. Sundar S., et al. Rapid accurate field diagnosis of Indian visceral leishmaniasis. Lancet 1998, 351(9102):563-565.
87. Luz K.G., et al. Prevalence of anti-Leishmania donovani antibody among Brazilian blood donors and multiply transfused hemodialysis patients. Am J Trop Med Hyg 1997, 57(2):168-171.
88. Otero A.C., et al. Short report: occurrence of Leishmania donovani DNA in donated blood from seroreactive Brazilian blood donors. Am J Trop Med Hyg 2000, 62(1):128-131.
89. Farajnia S., et al. Development and evaluation of Leishmania infantum rK26 ELISA for serodiagnosis of visceral leishmaniasis in Iran. Parasitology 2008, 135(9):1035-1041.
90. Mandal J., et al. Evaluation of direct agglutination test, rk39 Test, and ELISA for the diagnosis of visceral leishmaniasis. Am J Trop Med Hyg 2008, 79(1):76-78.
91. Babakhan L., et al. Rapid detection of Leishmania infantum infection in dogs: a comparative study using fast agglutination screening test (FAST) and direct agglutination test (DAT) in Iran. Parasitol Res 2009, 105(3):717-720.
92. Palatnik-de-Sousa C.B., et al. Leishmania donovani: titration of antibodies to the fucose-mannose ligand as an aid in diagnosis and prognosis of visceral leishmaniasis. Trans R Soc Trop Med Hyg 1995, 89(4):390-393.
93. Pattabhi S., et al. Design, development and evaluation of rK28-based point-of-care tests for improving rapid diagnosis of visceral leishmaniasis. PLoS Negl Trop Dis 2010, 4(9).
94. Zijlstra E.E., et al. rK39 enzyme-linked immunosorbent assay for diagnosis of Leishmania donovani infection. Clin Diagn Lab Immunol 1998, 5(5):717-720.
95. Gavgani A.S., Vatan S.K., Ghazanchaei A. KAtex antigen-detection test as a diagnostic tool for latent visceral leishmaniasis cases. African J Biotechnol 2008, 7(7):852-859.
96. Singh D.P., et al. In search of an ideal test for diagnosis and prognosis of kala-azar. J Health Popul Nutr 2010, 28(3):281-285.
97. Attar Z.J., el-Safi C.M., Carney J., Azazy A., El-Hadi M., Dourado C., et al. Latex agglutination test for the detection of urinary antigens in visceral leishmaniasis. Acta Trop 2001, 78(1):11-16.
98. Fisa R., et al. Leishmania infantum DNA detection in urine from patients with visceral leishmaniasis and after treatment control. Am J Trop Med Hyg 2008, 78(5):741-744.
99. de Lima V.M., et al. Diminished CD4+/CD25+ T cell and increased IFN-gamma levels occur in dogs vaccinated with Leishmune in an endemic area for visceral leishmaniasis. Vet Immunol Immunopathol 2010, 135(3-4):296-302.