Production of a Shigella sonnei vaccine based on generalized modules for membrane antigens (GMMA), 1790GAHB

PLoS ONE

Volumn 10, Issue 8, 2015, Pages

  Gerke, Christiane ^a   Colucci, Anna Maria ^a   Giannelli, Carlo ^a   Sanzone, Silvia ^a   Vitali, Claudia Giorgina ^b   Sollai, Luigi ^a   Rossi, Omar ^a   Martin, Laura B ^a   Auerbach, Jochen ^a   Di Cioccio, Vito ^a   Saul, Allan ^a  

^a Sclavo Behring Vaccines Institute for Global Health Srl   (Italy)

^b NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

1790 GAHB; ALUMINUM HYDROXIDE; BACTERIUM LIPOPOLYSACCHARIDE; GENERALIZED MODULES OF MEMBRANE ANTIGEN; INTERLEUKIN 6; LIPID A; MEMBRANE ANTIGEN; O ANTIGEN; OUTER MEMBRANE PROTEIN; PLACEBO; SHIGELLA VACCINE; UNCLASSIFIED DRUG; BACTERIUM ANTIBODY; IMMUNOGLOBULIN G; LIPOPOLYSACCHARIDE; RECOMBINANT VACCINE;

ANIMAL CELL; ANIMAL EXPERIMENT; ANTIBODY RESPONSE; ARTICLE; BACTERIAL STRAIN; CONTROLLED STUDY; CYTOKINE PRODUCTION; DRUG TOLERABILITY; FEMALE; FEVER; GOOD MANUFACTURING PRACTICE; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MONOCYTE; MOUSE; NONHUMAN; PLASMID; RABBIT; SINGLE DRUG DOSE; VACCINE PRODUCTION; ANIMAL; BAGG ALBINO MOUSE; BIOSYNTHESIS; BLOOD; CYTOLOGY; DYSENTERY, BACILLARY; ENZYME LINKED IMMUNOSORBENT ASSAY; GENETICS; HUMAN; IMMUNOLOGY; METABOLISM; MONONUCLEAR CELL; SHIGELLA SONNEI;

ANIMALS; ANTIBODIES, BACTERIAL; DYSENTERY, BACILLARY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOGLOBULIN G; INTERLEUKIN-6; LEUKOCYTES, MONONUCLEAR; LIPOPOLYSACCHARIDES; MICE; MICE, INBRED BALB C; MONOCYTES; O ANTIGENS; RABBITS; SHIGELLA SONNEI; VACCINES, SYNTHETIC;

EID: 84941975846     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0134478     Document Type: Article

References (44)

1. Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012; 380: 2197-2223. doi: 10.1016/S0140-6736(12)61689-4 PMID: 23245608
2. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012; 380: 2095-2128. doi: 10.1016/S0140-6736(12)61728-0 PMID: 23245604
3. Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, et al. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013; 382: 209-222. doi: 10.1016/ S0140-6736(13)60844-2 PMID: 23680352
4. Livio S, Strockbine NA, Panchalingam S, Tennant SM, Barry EM, Marohn ME, et al. Shigella isolates from the global enteric multicenter study inform vaccine development. Clin Infect Dis. 2014; 59: 933-941. doi: 10.1093/cid/ciu468 PMID: 24958238
5. Levine MM, Kotloff KL, Barry EM, Pasetti MF, Sztein MB. Clinical trials of Shigella vaccines: two steps forward and one step back on a long, hard road. Nat Rev Microbiol. 2007; 5: 540-553. PMID: 17558427
6. Chang Z, Lu S, Chen L, Jin Q, Yang J. Causative species and serotypes of shigellosis in mainland China: systematic review and meta-analysis. PLoS One. 2012; 7: e52515. doi: 10.1371/journal.pone. 0052515 PMID: 23285073
7. Vinh H, Nhu NTK, Nga TVT, Duy PT, Campbell JI, Hoang NVM, et al. A changing picture of shigellosis in southern Vietnam: shifting species dominance, antimicrobial susceptibility and clinical presentation. BMC Infect Dis. 2009; 9: 204. doi: 10.1186/1471-2334-9-204 PMID: 20003464
8. Ekdahl K, Andersson Y. The epidemiology of travel-associated shigellosis - regional risks, seasonality and serogroups. J Infect. 2005; 51: 222-229. PMID: 16230220
9. von Seidlein L, Kim DR, Ali M, Lee H, Wang X, Thiem VD, et al. A multicentre study of Shigella diarrhoea in six Asian countries: disease burden, clinical manifestations, and microbiology. PLoS Med. 2006; 3: e353. PMID: 16968124
10. Gu B, Ke X, Pan S, Cao Y, Zhuang L, Yu R, et al. Prevalence and trends of aminoglycoside resistance in Shigella worldwide, 1999-2010. J Biomed Res. 2013; 27: 103-115. doi: 10.7555/JBR.27.20120125 PMID: 23554801
11. Zhang W, Luo Y, Li J, Lin L, Ma Y, Hu C, et al. Wide dissemination of multidrug-resistant Shigella isolates in China. J Antimicrob Chemother. 2011; 66: 2527-2535. doi: 10.1093/jac/dkr341 PMID: 21859815
12. DuPont HL, Hornick RB, Snyder MJ, Libonati JP, Formal SB, Gangarosa EJ. Immunity in shigellosis. II. Protection induced by oral live vaccine or primary infection. J Infect Dis. 1972; 125: 12-16. PMID: 4550416
13. Ferreccio C, Prado V, Ojeda A, Cayyazo M, Abrego P, Guers L, et al. Epidemiologic patterns of acute diarrhea and endemic Shigella infections in children in a poor periurban setting in Santiago, Chile. Am J Epidemiol. 1991; 134: 614-627. PMID: 1951266
14. Cohen D, Block C, Green MS, Lowell G, Ofek I. Immunoglobulin M, A, and G antibody response to lipopolysaccharide O antigen in symptomatic and asymptomatic Shigella infections. J Clin Microbiol. 1989; 27: 162-167. PMID: 2463995
15. Cohen D, Green MS, Block C, Slepon R, Ofek I. Prospective study of the association between serum antibodies to lipopolysaccharide O antigen and the attack rate of shigellosis. J Clin Microbiol. 1991; 29: 386-389. PMID: 1706731
16. Ashkenazi S, Cohen D. An update on vaccines against Shigella. Ther Adv Vaccines. 2013; 1: 113-123. doi: 10.1177/2051013613500428 PMID: 24757519
17. Venkatesan MM, Ranallo RT. Live-attenuated Shigella vaccines. Expert Rev Vaccines. 2006; 5: 669-686. PMID: 17181440
18. Kaminski RW, Oaks EV. Inactivated and subunit vaccines to prevent shigellosis. Expert Rev Vaccines. 2009; 8: 1693-1704. doi: 10.1586/erv.09.127 PMID: 19943764
19. Martinez-Becerra FJ, Kissmann JM, Diaz-McNair J, Choudhari SP, Quick AM, Mellado-Sanchez G, et al. Broadly protective Shigella vaccine based on type III secretion apparatus proteins. Infect Immun. 2012; 80: 1222-1231. doi: 10.1128/IAI.06174-11 PMID: 22202122
20. Cohen D, Ashkenazi S, Green MS, Gdalevich M, Robin G, Slepon R, et al. Double-blind vaccine-controlled randomised efficacy trial of an investigational Shigella sonnei conjugate vaccine in young adults. Lancet. 1997; 349: 155-159. PMID: 9111538
21. Passwell JH, Ashkenzi S, Banet-Levi Y, Ramon-Saraf R, Farzam N, Lerner-Geva L, et al. Age-related efficacy of Shigella O-specific polysaccharide conjugates in 1-4-year-old Israeli children. Vaccine. 2010; 28: 2231-2235. doi: 10.1016/j.vaccine.2009.12.050 PMID: 20056180
22. Berlanda Scorza F, Colucci AM, Maggiore L, Sanzone S, Rossi O, Ferlenghi I, et al. High yield production process for Shigella outer membrane particles. PLoS One. 2012; 7: e35616. doi: 10.1371/journal. pone.0035616 PMID: 22701551
23. Koeberling O, Ispasanie E, Hauser J, Rossi O, Pluschke G, Caugant DA, et al. A broadly-protective vaccine against meningococcal disease in sub-Saharan Africa based on Generalized Modules for Membrane Antigens (GMMA). Vaccine. 2014; 32: 2688-2695. doi: 10.1016/j.vaccine.2014.03.068 PMID: 24704334
24. Kulp A, Kuehn MJ. Biological functions and biogenesis of secreted bacterial outer membrane vesicles. Annu Rev Microbiol. 2010; 64: 163-184. doi: 10.1146/annurev.micro.091208.073413 PMID: 20825345
25. Rossi O, Pesce I, Giannelli C, Aprea S, Caboni M, Citiulo F, et al. Modulation of Endotoxicity of Shigella Generalized Modules for Membrane Antigens (GMMA) by Genetic Lipid A Modifications: Relative Activation of TLR4 and TLR2 Pathways in Different Mutants. J Biol Chem. 2014; 289: 24922-24935. doi: 10.1074/jbc.M114.566570 PMID: 25023285
26. Ellis TN, Kuehn MJ. Virulence and immunomodulatory roles of bacterial outer membrane vesicles. Microbiol Mol Biol Rev. 2010; 74: 81-94. doi: 10.1128/MMBR.00031-09 PMID: 20197500
27. Clementz T, Bednarski JJ, Raetz CR. Function of the htrB high temperature requirement gene of Escherchia coli in the acylation of lipid A. J Biol Chem. 1996; 271: 12095-12102. PMID: 8662613
28. Clementz T, Zhou Z, Raetz CR. Function of the Escherichia coli msbB gene, a multicopy suppressor of htrB knockouts, in the acylation of lipid A. J Biol Chem. 1997; 272: 10353-10360. PMID: 9099672
29. Stoddard MB, Pinto V, Keiser PB, Zollinger W. Evaluation of a whole-blood cytokine release assay for use in measuring endotoxin activity of group B Neisseria meningitidis vaccines made from lipid A acylation mutants. Clin Vaccine Immunol. 2010; 17: 98-107. doi: 10.1128/CVI.00342-09 PMID: 19923573
30. Hoffmann S, Peterbauer A, Schindler S, Fennrich S, Poole S, Mistry Y, et al. International validation of novel pyrogen tests based on human monocytoid cells. J Immunol Methods. 2005; 298: 161-173. PMID: 15847806
31. Pyrogens. In: European Pharmacopoeia. 8th ed. Strasbourg, Cedex: Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). 2013. chapter 2.6.8.
32. Claassen I, Meylis J, van der Ley P, Peeters C, Brons H, Robert J, et al. Production, characterization and control of a Neisseria meningitidis hexavalent class 1 outer membrane protein containing vesicle vaccine. Vaccine. 1996; 14: 1001-1008. PMID: 8873395
33. Formal SB, Kent TH, May HC, Palmer A, Falkow S, LaBrec EH. Protection of monkeys against experimental shigellosis with a living attenuated oral polyvalent dysentery vaccine. J Bacteriol. 1966; 92: 17-22. PMID: 4957431
34. Makino S, Sasakawa C, Kamata K, Kurata T, Yoshikawa M. A genetic determinant required for continuous reinfection of adjacent cells on large plasmid in S. flexneri 2a. Cell. 1986; 46: 551-555. PMID: 3524856
35. Prunier A-L, Schuch R, Fernandez RE, Mumy KL, Kohler H, McCormick BA, et al. nadA and nadB of Shigella flexneri 5a are antivirulence loci responsible for the synthesis of quinolinate, a small molecule inhibitor of Shigella pathogenicity. Microbiology. 2007; 153: 2363-2372. PMID: 17600080
36. Rossi O, Maggiore L, Necchi F, Koeberling O, MacLennan CA, Saul A, et al. Comparison of Colorimetric Assays with Quantitative Amino Acid Analysis for Protein Quantification of Generalized Modules for Membrane Antigens (GMMA). Mol Biotechnol. 2014;in press.
37. Micoli F, Rondini S, Gavini M, Pisoni I, Lanzilao L, Colucci AM, et al. A scalable method for O-antigen purification applied to various Salmonella serovars. Anal Biochem. 2013; 434: 136-145. doi: 10.1016/j.ab.2012.10.038 PMID: 23142430
38. Robbins JB, Kubler-Kielb J, Vinogradov E, Mocca C, Pozsgay V, Shiloach J, et al. Synthesis, characterization, and immunogenicity in mice of Shigella sonnei O-specific oligosaccharide-core-protein conjugates. Proc Natl Acad Sci U S A. 2009; 106: 7974-7978. doi: 10.1073/pnas.0900891106 PMID: 19346477
39. Westphal O, Jann K. Bacterial lipopolysaccharides: extraction with phenol-water and further application of the procedure. 1965; 5: 83-91.
40. Micoli F, Rondini S, Pisoni I, Proietti D, Berti F, Costantino P, et al. Vi-CRM197 as a new conjugate vaccine against Salmonella Typhi. Vaccine. 2011; 29: 712-720. doi: 10.1016/j.vaccine.2010.11.022 PMID: 21115057
41. Moscardo E, Maurin A, Dorigatti R, Champeroux P, Richard S. An optimised methodology for the neurobehavioural assessment in rodents. J Pharmacol Toxicol Methods. 2007; 56: 239-255. PMID: 17629504
42. Jiang Y, Yang F, Zhang X, Yang J, Chen L, Yan Y, et al. The complete sequence and analysis of the large virulence plasmid pSS of Shigella sonnei. Plasmid. 2005; 54: 149-159. PMID: 16122562
43. Schromm AB, Brandenburg K, Loppnow H, Moran AP, Koch MH, Rietschel ET, et al. Biological activities of lipopolysaccharides are determined by the shape of their lipid A portion. Eur J Biochem. 2000; 267: 2008-2013. PMID: 10727940
44. Greisman SE, Hornick RB. Comparative pyrogenic reactivity of rabbit and man to bacterial endotoxin. Proc Soc Exp Biol Med. 1969; 131: 1154-1158. PMID: 4897836