A virosomal vaccine against candidal vaginitis: Immunogenicity, efficacy and safety profile in animal models

Vaccine

Volumn 30, Issue 30, 2012, Pages 4490-4498

  De Bernardis, Flavia ^a   Amacker, Mario ^b   Arancia, Silvia ^a   Sandini, Silvia ^a   Gremion, Christel ^b,c   Zurbriggen, Rinaldo ^b,d   Moser, Christian ^b   Cassone, Antonio ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b Pevion Biotech AG   (Switzerland)

^c CSL Behring AG   (Switzerland)

^d LONZA AG   (Switzerland)

Author keywords

Aspartyl proteinase 2; Candida albicans; Recurrent vulvo vaginal candidiasis; Vaccine; Virosomes

Indexed keywords

IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; PEV7 VACCINE; UNCLASSIFIED DRUG; VIROSOME VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY RESPONSE; ARTICLE; CANDIDA ALBICANS; FEMALE; IMMUNIZATION; MALE; MOUSE; NONHUMAN; PRIORITY JOURNAL; PROSPECTIVE STUDY; RAT; VAGINA CANDIDIASIS; VAGINA DISCHARGE;

ADMINISTRATION, INTRAVAGINAL; ANIMALS; ANTIBODIES, FUNGAL; ASPARTIC ACID ENDOPEPTIDASES; CANDIDA ALBICANS; CANDIDIASIS, VULVOVAGINAL; CROSS REACTIONS; FEMALE; FUNGAL PROTEINS; FUNGAL VACCINES; MALE; MICE; ORTHOMYXOVIRIDAE; RATS; RATS, WISTAR; TOXICITY TESTS; VIROSOMES;

EID: 84862020845     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.04.069     Document Type: Article

References (41)

1. Nucci M., Marr K.A. Emerging fungal diseases. Clinical Infectious Diseases 2005, 41:521-526.
2. Pfaller M.A., Diekema D.J. Epidemiology of invasive candidiasis: a persistent public health problem. Clinical Microbiology Reviews 2007, 20(1):133-163.
3. Sobel J.D. Vulvovaginal candidiasis. Lancet 2007, 369:1961-1971.
4. Fidel P.I., Sobel J.D. Immunopathogenesis of recurrent vulvovaginal candidiasis. Clinical Microbiology Reviews 1996, 9:335-348.
5. Babula O., Lazdāne G., Kroica J., Linhares I.M., Ledger W.J., Witkin S.S. Frequency of interleukin-4 (IL-4) -589 gene polymorphism and vaginal concentrations of IL-4, nitric oxide, and mannose-binding lectin in women with recurrent vulvovaginal candidiasis. Clinical Infectious Diseases 2005, 40(May (9)):1258-1262.
6. Netea M.G., Maródi L. Innate immune mechanisms for recognition and uptake of Candida species. Trends in Immunology 2010, 31(September (9)):346-353.
7. Naglik J.R., Challacombe S.J., Hube B. Candida albicans secreted aspartyl proteinases in virulence and pathogenesis. Microbiology and Molecular Biology Reviews 2003, 67:400-428.
8. De Bernardis F., Sullivan P.A., Cassone A. Aspartyl proteinases of Candida albicans and their role in pathogenicity. Medical Mycology 2001, 39(4):303-313.
9. Cassone A., De Bernardis F., Santoni G. Anticandidal immunity and vaginitis: novel chances for immune intervention. Infection and Immunity 2007, 75:4675-4686.
10. Bein M., Schaller M., Korting H.C. The secreted aspartic proteinases as a new target in the therapy of candidiasis. Current Drug Targets 2002, 3:351-357.
11. Lermann U., Morschhäuser J. Secreted aspartic proteases are not required for invasion of reconstituted human epithelia by Candida albicans. Microbiology 2008, 154:3281-3295.
12. Naglik J.R., Moyes D., Makwana J., Kanzaria P., Tsichlaki E., Weindl G., et al. Quantitative expression of the Candida albicans secreted aspartyl proteinase gene family in human oral and vaginal candidiasis. Microbiology 2008, 154(November (Pt 11)):3266-3280.
13. Correia A., Lermann U., Teixeira L., Cerca F., Botelho S., da Costa R.M., et al. Limited role of secreted aspartyl proteinases Sap1 to Sap6 in Candida albicans virulence and host immune response in murine hematogenously disseminated candidiasis. Infection and Immunity 2010, 78:4839-4849.
14. Cassone A., De Bernardis F., Mondello F., Ceddia T., Agatensi L. Evidence for a correlation between proteinase secretion and vulvovaginal candidosis. Journal of Infectious Diseases 1987, 156(November (5)):777-783.
15. Lian C.H., Liu W.D. Differential expression of Candida albicans secreted aspartyl proteinase in human vulvovaginal candidiasis. Mycoses 2007, 50:383-390.
16. De Bernardis F., Boccanera M., Adriani D., Spreghini E., Santoni G., Cassone A. Protective role of antimannan and anti-aspartyl proteinase antibodies in an experimental model of Candida albicans vaginitis in rats. Infection and Immunity 1997, 68:3297-3304.
17. De Bernardis F., Liu H., O'Mahony R., et al. Human domain antibodies against virulence traits of Candida albicans inhibit fungus adherence to vaginal epithelium and protect against experimental vaginal candidiasis. Journal of Infectious Diseases 2007, 195:149-157.
18. Sandini S., La Valle R., Deaglio S., Malavasi F., Cassone A., De Bernardis F. A highly immunogenic recombinant and truncated protein of the secreted aspartic proteases family (rSap2t) of Candida albicans as a mucosal anticandidal vaccine. FEMS Immunology & Medical Microbiology 2011, 62(July (2)):215-224.
19. Moser C., Amacker M., Zurbriggen R. Influenza virosomes as a vaccine adjuvant and carrier system. Expert Rev Vaccines 2011, 10:437-446.
20. Bovier P.A. Epaxal: a virosomal vaccine to prevent hepatitis A infection. Expert Review of Vaccines 2008, 7(October (8)):1141-1150.
21. Herzog C., Hartmann K., Künzi V., Kürsteiner O., Mischler R., Lazar H., et al. Eleven years of Inflexal V-a virosomal adjuvanted influenza vaccine. Vaccine 2009, 27(July (33)):4381-4387.
22. Cassone A., Boccanera M., Adriani D., Santoni G., De Bernardis F. Rat clearing a vaginal infection by Candida albicans acquired specific antibody-mediated resistance to vaginal reinfection. Infection and Immunity 1995, 63:2619-2625.
23. Kammer A.R., Amacker M., Rasi S., Westerfeld N., Gremion C., Neuhaus D., et al. A new and versatile virosomal antigen delivery system to induce cellular and humoral immune responses. Vaccine 2007, 25(October (41)):7065-7074.
24. Naglik J.R., Rodgers C.A., Shirlaw P.J., Dobbie J.L., Fernandes-Naglik L.L., Greenspan D., et al. Differential expression of Candida albicans secreted aspartyl proteinase and phospholipase B genes in humans correlates with active oral and vaginal infections. Journal of Infectious Diseases 2003, 188:469-479.
25. Boyaka P.N., Marinaro M., Vancott J.L., Takahashi I., Fujihashi K., Yamamoto M., et al. Strategies for mucosal vaccine development. American Journal of Tropical Medicine and Hygiene 1999, 60:35-45.
26. Cassone A. Fungal vaccine: real progress from real challenges. Lancet Infectious Diseases 2008, 8:114-124.
27. Cutler J.E., Deepe G.S., Klein B.S. Advances in combating fungal diseases: vaccines on the threshold. Nature Reviews Microbiology 2007, 5:13-28.
28. Dan M.J., Levitz S.M. Prospects for development of vaccines against fungal diseases. Drug Resistance Updates 2006, 9:105-110.
29. Xin H., Dziadek S., Bundle D.R., Cutler J.E. Synthetic glycopeptide vaccines combining beta-mannan and peptide epitopes induce protection against candidiasis. Proceedings of the National Academy of Sciences of the United States of America 2008, 105:13526-13531.
30. Torosantucci A., Bromuro C., Chiani P., De Bernardis F., Berti F., Galli C., et al. A novel glyco-conjugate vaccine against fungal pathogens. Journal of Experimental Medicine 2005, 202:597-606.
31. Spellberg B.J., Ibrahim A.S., Avanesian V., Fu Y., Myers C., Phan Q.T., et al. Efficacy of the anti-Candida rAls3p-N or rAls1p-N vaccines against disseminated and mucosal candidiasis. Journal of Infectious Diseases 2006, 194:256-260.
32. Fidel P.L., Cutler J.E. Prospects for development of a vaccine to prevent and control vaginal candidiasis. Current Infectious Disease Reports 2011, 13:102-107.
33. De Bernardis F., Arancia S., Morelli L., Hube B., Sanglard D., Schäfer W., et al. Evidence that members of the secretory aspartyl proteinase gene family, in particular SAP2, are virulence factors for Candida vaginitis. Journal of Infectious Diseases 1999, 179:201-208.
34. Rahman D., Mistry M., Thavaraj S., Challacombe S.J., Naglik J.R. Murine model of concurrent oral and vaginal Candida albicans colonization to study epithelial host-pathogen interactions. Microbes and Infection 2007, 9:615-622.
35. Cech P.G., Aebi T., Abdallah M.S., Mpina M., Machunda E.B., Westerfeld N., et al. Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. PLoS One 2011, 6(7):e22273.
36. Wiedermann U., Wiltschke C., Jasinska J., Kundi M., Zurbriggen R., Garner-Spitzer E., et al. A virosomal formulated Her-2/neu multi-peptide vaccine induces Her-2/neu-specific immune responses in patients with metastatic breast cancer: a phase I study. Breast Cancer Research and Treatment 2010, 119(February (3)):673-683.
37. De Bernardis F., Boccanera M., Adriani D., Girolamo A., Cassone A. Intravaginal and intranasal immunizations are equally effective in inducing vaginal antibodies and conferring protection against vaginal candidiasis. Infection and Immunity 2002, 70:2725-2729.
38. Naglik J.R., Moyes D., Makwana J., Kanzaria P., Tsichlaki E., Weindl G., et al. Quantitative expression of the Candida albicans secreted aspartyl proteinase gene family in human oral and vaginal candidiasis. Microbiology 2008, 154:3266-3280.
39. Naglik J., Albrecht A., Bader O., Hube B. Candida albicans proteinases and host/pathogen interactions. Cell Microbiology 2004, 10:915-926.
40. Gropp K., Schild L., Schindler S., Hube B., Zipfel P.F., Skerka C. The yeast Candida albicans evades human complement attack by secretion of aspartic proteases. Molecular Immunology 2009, 47(December (2-3)):465-475.
41. Pietrella D., Rachini A., Pandey N., Schild L., Netea M., Bistoni F., et al. The Inflammatory response induced by aspartic proteases of Candida albicans is independent of proteolytic activity. Infection and Immunity 2010, 78:4754-4762.