Development of a recombinant toxin fragment vaccine for Clostridium difficile infection

Vaccine

Volumn 32, Issue 24, 2014, Pages 2812-2818

  Karczewski, Jerzy ^a   Zorman, Julie ^a   Wang, Su ^a   Miezeiewski, Matthew ^b   Xie, Jinfu ^a   Soring, Keri ^b   Petrescu, Ioan ^a   Rogers, Irene ^a   Thiriot, David S ^a   Cook, James C ^a   Chamberlin, Mihaela ^c   Xoconostle, Rachel F ^a   Nahas, Debbie D ^a   Joyce, Joseph G ^a   Bodmer, Jean Luc ^a,d   Heinrichs, Jon H ^a   Secore, Susan ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Eurofins Medinet Inc   (Germany)

^c Merck Research Laboratories Vaccine Drug Product Development ^*  (United States)

^d Cambridge Discovery Park   (United States)

Author keywords

Clostridium difficile; Recombinant vaccine; TcdA; TcdB

Indexed keywords

CLINDAMYCIN; CLOSTRIDIUM TOXIN; CLOSTRIDIUM VACCINE; IMMUNOGLOBULIN G; RECOMBINANT VACCINE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CLOSTRIDIUM DIFFICILE INFECTION; CONTROLLED STUDY; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG SAFETY; IMMUNOGENICITY; LARGE SCALE PRODUCTION; MALE; NONHUMAN; PRIORITY JOURNAL; SYRIAN HAMSTER;

CLOSTRIDIUM DIFFICILE; RECOMBINANT VACCINE; TCDA; TCDB;

ANIMALS; ANTIBODIES, BACTERIAL; ANTIBODIES, NEUTRALIZING; BACTERIAL PROTEINS; BACTERIAL TOXINS; BACTERIAL VACCINES; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM INFECTIONS; ENTEROCOLITIS, PSEUDOMEMBRANOUS; ENTEROTOXINS; IMMUNOGLOBULIN G; MALE; MESOCRICETUS; NEUTRALIZATION TESTS; RECOMBINANT PROTEINS; VACCINES, SYNTHETIC;

EID: 84899988599     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.02.026     Document Type: Article

References (43)

1. Lo Vecchio A., Zacur G.M. Clostridium difficile infection: an update on epidemiology, risk factors, and therapeutic options. Curr Opin Gastroenterol 2012, 28(January (1)):1-9.
2. Cohen S.H., Gerding D.N., Johnson S., Kelly C.P., Loo V.G., McDonald L.C., et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the ociety for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol 2010, 31(May (5)):431-455.
3. Loo V.G., Bourgault A.M., Poirier L., Lamothe F., Michaud S., Turgeon N., et al. Host and pathogen factors for Clostridium difficile infection and colonization. N Engl J Med 2006, 365(November (18)):1693-1703.
4. McDonald L.C., Killgore G.E., Thompson A., Owens R.C., Kazakova S.V., Sambol S.P., et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N Engl J Med 2005, 353(December (23)):2433-2441.
5. Muto C.A. Why are antibiotic-resistant nosocomial infections spiraling out of control?. Infect Control Hosp Epidemiol 2005, 26(January (1)):10-12.
6. Pepin J., Valiquette L., Alary M.E., Villemure P., Pelletier A., Forget K., et al. Clostridium difficile-associated diarrhea in a region of Quebec from 1991 to 2003: a changing pattern of disease severity. CMAJ 2004, 171(August (5)):466-472.
7. Zar F.A., Bakkanagari S.R., Moorthi K.M., Davis M.B. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis 2007, 45(August (3)):302-307.
8. Pituch H., Bakker D., Kuijper E., Obuch-Woszczatynski P., Wultanska D., Nurzynska G., et al. First isolation of Clostridium difficile PCR-ribotype 027/toxinotype III in Poland. Pol J Microbiol 2008, 57(3):267-268.
9. Hookman P., Barkin J.S. Clostridium difficile associated infection, diarrhea and colitis. World J Gastroenterol 2009, 15(April (13)):1554-1580.
10. Venugopal A.A., Johnson S. Fidaxomicin: a novel macrocyclic antibiotic approved for treatment of Clostridium difficile infection. Clin Infect Dis 2011, 54(February (4)):568-574.
11. Lowy I., Molrine D.C., Leav B.A., Blair B.M., Baxter R., Gerding D.N., et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med 2010, 362(3):197-205.
12. Kotloff K.L., Wasserman S.S., Losonsky G.A., Thomas W., Nichols R., Edelman R., et al. Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults. Infect Immun 2001, 69(February (2)):988-995.
13. Lyerly D.M., Krivan H.C., Wilkins T.D. Clostridium difficile: its disease and toxins. Clin Microbiol Rev 1988, 1(January (1)):1-18.
14. Hamm E.E., Voth D.E., Ballard J.D. Identification of Clostridium difficile toxin B cardiotoxicity using a zebrafish embryo model of intoxication. Proc Natl Acad Sci U S A 2006, 103(September (38)):14176-14181.
15. Cohen S.H., Tang Y.J., Silva J. Analysis of the pathogenicity locus in Clostridium difficile strains. J Infect Dis 2000, 181(February (2)):659-663.
16. Riegler M., Sedivy R., Sogukoglu T., Castagliuolo I., Pothoulakis C., Cosentini E., et al. Epidermal growth factor attenuates Clostridium difficile toxin A- and B-induced damage of human colonic mucosa. Am J Physiol 1997, 273(November (5 Pt 1)):G1014-G1022.
17. Amimoto K., Noro T., Oishi E., Shimizu M. A novel toxin homologous to large clostridial cytotoxins found in culture supernatant of Clostridium perfringens type C. Microbiology (Reading, England) 2007, 153(April (Pt 4)):1198-1206.
18. von Eichel-Streiber C., Boquet P., Sauerborn M., Thelestam M. Large clostridial cytotoxins - a family of glycosyltransferases modifying small GTP-binding proteins. Trends Microbiol 1996, 4(October (10)):375-382.
19. Spyres L.M., Qa'Dan M., Meader A., Tomasek J.J., Howard E.W., Ballard J.D. Cytosolic delivery and characterization of the TcdB glucosylating domain by using a heterologous protein fusion. Infect Immun 2001, 69(January (1)):599-601.
20. Jank T., Giesemann T., Aktories K. Rho-glucosylating Clostridium difficile toxins A and B: new insights into structure and function. Glycobiology 2007, 17(April (4)):15R-22R.
21. Voth D.E., Ballard J.D. Clostridium difficile toxins: mechanism of action and role in disease. Clin Microbiol Rev 2005, 18(April (2)):247-263.
22. Jansen K.U., Rosolowsky M., Schultz L.D., Markus H.Z., Cook J.C., Donnelly J.J., et al. Vaccination with yeast-expressed cottontail rabbit papillomavirus (CRPV) virus-like particles protects rabbits from CRPV-induced papilloma formation. Vaccine 1995, 13(November (16)):1509-1514.
23. Johnson W.C. Analyzing protein circular dichroism spectra for accurate secondary structures. Proteins 1999, 35(May (3)):307-312.
24. Provencher S.W., Glockner J. Estimation of globular protein secondary structure from circular dichroism. Biochemistry 1981, 20(January (1)):33-37.
25. Sreerama N., Venyaminov S.Y., Woody R.W. Estimation of the number of alpha-helical and beta-strand segments in proteins using circular dichroism spectroscopy. Protein Sci 1999, 8(February (2)):370-380.
26. Sreerama N., Woody R.W. A self-consistent method for the analysis of protein secondary structure from circular dichroism. Anal Biochem 1993, 209(February (1)):32-44.
27. Sreerama N., Woody R.W. Poly(pro)II helices in globular proteins: identification and circular dichroic analysis. Biochemistry 1994, 33(August (33)):10022-10025.
28. Sreerama N., Woody R.W. Estimation of protein secondary structure from circular dichroism spectra: comparison of CONTIN, SELCON, and CDSSTR methods with an expanded reference set. Anal Biochem 2000, 287(December (2)):252-260.
29. Busch C., Hofmann F., Gerhard R., Aktories K. Involvement of a conserved tryptophan residue in the UDP-glucose binding of large clostridial cytotoxin glycosyltransferases. J Biol Chem 2000, 275(May (18)):13228-13234.
30. Jank T., Giesemann T., Aktories K. Clostridium difficile glucosyltransferase toxin B-essential amino acids for substrate binding. J Biol Chem 2007, 282(November (48)):35222-35231.
31. Reinert D.J., Jank T., Aktories K., Schulz G.E. Structural basis for the function of Clostridium difficile toxin B. J Mol Biol 2005, 351(September (5)):973-981.
32. Babcock G.J., Broering T.J., Hernandez H.J., Mandell R.B., Donahue K., Boatright N., et al. Human monoclonal antibodies directed against toxins A and B prevent Clostridium difficile-induced mortality in hamsters. Infect Immun 2006, 74(November (11)):6339-6347.
33. Genisyuerek S., Papatheodorou P., Guttenberg G., Schubert R., Benz R., Aktories K. Structural determinants for membrane insertion, pore formation and translocation of Clostridium difficile toxin B. Molecular Microbiology 2011, 79:1643-1654.
34. Torres J.F., Lyerly D.M., Hill J.E., Monath T.P. Evaluation of formalin-inactivated Clostridium difficile vaccines administered by parenteral and mucosal routes of immunization in hamsters. Infect Immun 1995, 63(December (12)):4619-4627.
35. Ochsner U.A., Bell S.J., O'Leary A.L., Hoang T., Stone K.C., Young C.L., et al. Inhibitory effect of REP3123 on toxin and spore formation in Clostridium difficile, and in vivo efficacy in a hamster gastrointestinal infection model. J Antimicrob Chemother 2009, 63(May (5)):964-971.
36. Foglia G., Shah S., Luxemburger C., Pietrobon P.J. Clostridium difficile: development of a novel candidate vaccine. Vaccine 2012, 30(June (29)):4307-4309.
37. Greenberg R.N., Marbury T.C., Foglia G., Warny M. Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine. Vaccine 2012, 30(March (13)):2245-2249.
38. Tian J.H., Fuhrmann S.R., Kluepfel-Stahl S., Carman R.J., Ellingsworth L., Flyer D.C. A novel fusion protein containing the receptor binding domains of C. difficile toxin A and toxin B elicits protective immunity against lethal toxin and spore challenge in preclinical efficacy models. Vaccine 2012, 30(June (28)):4249-4258.
39. Merrigan M., Venugopal A., Mallozzi M., Roxas B., Viswanathan V.K., Johnson S., et al. Human hypervirulent Clostridium difficile strains exhibit increased sporulation as well as robust toxin production. J Bacteriol 2010, 192(October (19)):4904-4911.
40. Wang H., Sun X., Zhang Y., Li S., Chen K., Shi L., et al. A chimeric toxin vaccine protects against primary and recurrent Clostridium difficile infection. Infect Immun 2012, 80(August (8)):2678-2688.
41. Palace G.P., Lazari P., Norton K. Analysis of the physicochemical interactions between Clostridium difficile toxins and cholestyramine using liquid chromatography with post-column derivatization. Biochim Biophys Acta 2001, 1546(March (1)):171-184.
42. Pruitt R.N., Lacy D.B. Toward a structural understanding of Clostridium difficile toxins A and B. Front Cell Infect Microbiol 2012, 2(March):28.
43. Marozsan A.J., Ma D., Nagashima K.A., Kennedy B.J., Kang Y.K., Arrigale R.R., et al. Protection against Clostridium difficile infection with broadly neutralizing antitoxin monoclonal antibodies. J Infect Dis 2012, 206(September (5)):706-713.