Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials

Vaccine

Volumn 31, Issue 42, 2013, Pages 4867-4873

  Arbues, Ainhoa ^a,b   Aguilo, Juan I ^a,b   Gonzalo Asensio, Jesus ^a,b,c   Marinova, Dessislava ^a,b   Uranga, Santiago ^a,b   Puentes, Eugenia ^d   Fernandez, Conchita ^d   Parra, Alberto ^d   Cardona, Pere Joan ^b,e   Vilaplana, Cristina ^b,e   Ausina, Vicente ^b,f   Williams, Ann ^g   Clark, Simon ^g   Malaga, Wladimir ^h,i   Guilhot, Christophe ^h,i   Gicquel, Brigitte ^j   Martin, Carlos ^a,b,c  

^a UNIVERSITY OF ZARAGOZA   (Spain)

^b INSTITUTO DE SALUD CARLOS III   (Spain)

^c HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^d BIOFABRI SL ^*  (Spain)

^e UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^f HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^g PUBLIC HEALTH ENGLAND   (United Kingdom)

^h INSTITUT DE PHARMACOLOGIE ET DE BIOLOGIE STRUCTURALE   (France)

ⁱ UNIVERSITÉ PAUL SABATIER   (France)

^j INSTITUT PASTEUR   (France)

more..

Author keywords

BCG; Live attenuated vaccines; Tuberculosis vaccines

Indexed keywords

BCG VACCINE; LIVE VACCINE; MTBVAC VACCINE; MYCOBACTERIUM TUBERCULOSIS VACCINE; UNCLASSIFIED DRUG; VIRULENCE FACTOR;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BACTERIAL GENE; BACTERIAL STRAIN; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG SYNTHESIS; FADD26 GENE; FEMALE; GENE DELETION; HUMAN; IMMUNOGENICITY; MALE; MOUSE; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PHOP GENE; PRIORITY JOURNAL; SINGLE DRUG DOSE;

BCG; LIVE ATTENUATED VACCINES; TUBERCULOSIS VACCINES;

ANIMALS; BACTERIAL PROTEINS; DISEASE MODELS, ANIMAL; FEMALE; GENE DELETION; GUINEA PIGS; MALE; MICE; MYCOBACTERIUM TUBERCULOSIS; TUBERCULOSIS; TUBERCULOSIS VACCINES; VACCINES, ATTENUATED; VIRULENCE FACTORS;

EID: 84884205459     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.07.051     Document Type: Article

References (38)

1. WHO Module 5: Tuberculosis. The immunological basis for immunization series 2011, World Health Organization.
2. Fine P.E. Variation in protection by BCG: implications of and for heterologous immunity. Lancet 1995, 346(November (8986)):1339-1345.
3. Brosch R., Gordon S.V., Garnier T., Eiglmeier K., Frigui W., Valenti P., et al. Genome plasticity of BCG and impact on vaccine efficacy. Proceedings of the National Academy of Sciences of the United States of America 2007, 104(March (13)):5596-5601.
4. Pym A.S., Brodin P., Brosch R., Huerre M., Cole S.T. Loss of RD1 contributed to the attenuation of the live tuberculosis vaccines Mycobacterium bovis BCG and Mycobacterium microti. Molecular Microbiology 2002, 46(November (3)):709-717.
5. Leung A.S., Tran V., Wu Z., Yu X., Alexander D.C., Gao G.F., et al. Novel genome polymorphisms in BCG vaccine strains and impact on efficacy. BMC Genomics 2008, 9:413.
6. Liu J., Tran V., Leung A.S., Alexander D.C., Zhu B. BCG vaccines: their mechanisms of attenuation and impact on safety and protective efficacy. Human Vaccines 2009, 5(February (2)):70-78.
7. Behr M.A., Small P.M. Has BCG attenuated to impotence?. Nature 1997, 389(September (6647)):133-134.
8. Tseng C.L., Oxlade O., Menzies D., Aspler A., Schwartzman K. Cost-effectiveness of novel vaccines for tuberculosis control: a decision analysis study. BMC Public Health 2011, 11:55.
9. Young D., Dye C. The development and impact of tuberculosis vaccines. Cell 2006, 124(February (4)):683-687.
10. Abu-Raddad L.J., Sabatelli L., Achterberg J.T., Sugimoto J.D., Longini I.M., Dye C., et al. Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics. Proceedings of the National Academy of Sciences of the United States of America 2009, 106(August (33)):13980-13985.
11. Perez E., Samper S., Bordas Y., Guilhot C., Gicquel B., Martin C. An essential role for phoP in Mycobacterium tuberculosis virulence. Molecular Microbiology 2001, 41(July (1)):179-187.
12. Gonzalo Asensio J., Maia C., Ferrer N.L., Barilone N., Laval F., Soto C.Y., et al. The virulence-associated two-component PhoP-PhoR system controls the biosynthesis of polyketide-derived lipids in Mycobacterium tuberculosis. The Journal of Biological Chemistry 2006, 281(January (3)):1313-1316.
13. Gonzalo-Asensio J., Soto C.Y., Arbues A., Sancho J., del Carmen Menendez M., Garcia M.J., et al. The Mycobacterium tuberculosis phoPR operon is positively autoregulated in the virulent strain H37Rv. Journal of Bacteriology 2008, 190(November (21)):7068-7078.
14. Frigui W., Bottai D., Majlessi L., Monot M., Josselin E., Brodin P., et al. Control of M. tuberculosis ESAT-6 secretion and specific T cell recognition by PhoP. PLoS Pathogens 2008, 4(February (2)):e33.
15. Walters S.B., Dubnau E., Kolesnikova I., Laval F., Daffe M., Smith I. The Mycobacterium tuberculosis PhoPR two-component system regulates genes essential for virulence and complex lipid biosynthesis. Molecular Microbiology 2006, 60(April (2)):312-330.
16. Martin C., Williams A., Hernandez-Pando R., Cardona P.J., Gormley E., Bordat Y., et al. The live Mycobacterium tuberculosis phoP mutant strain is more attenuated than BCG and confers protective immunity against tuberculosis in mice and guinea pigs. Vaccine 2006, 24(April (17)):3408-3419.
17. Aguilar D., Infante E., Martin C., Gormley E., Gicquel B., Hernandez Pando R. Immunological responses and protective immunity against tuberculosis conferred by vaccination of Balb/C mice with the attenuated Mycobacterium tuberculosis (phoP) SO2 strain. Clinical and Experimental Immunology 2007, 147(February (2)):330-338.
18. Cardona P.J., Asensio J.G., Arbues A., Otal I., Lafoz C., Gil O., et al. Extended safety studies of the attenuated live tuberculosis vaccine SO2 based on phoP mutant. Vaccine 2009, 27(April (18)):2499-2505.
19. Verreck F.A., Vervenne R.A., Kondova I., van Kralingen K.W., Remarque E.J., Braskamp G., et al. MVA.85A boosting of BCG and an attenuated, phoP deficient M. tuberculosis vaccine both show protective efficacy against tuberculosis in rhesus macaques. PLoS ONE 2009, 4(4):e5264.
20. Kamath A.T., Fruth U., Brennan M.J., Dobbelaer R., Hubrechts P., Ho M.M., et al. New live mycobacterial vaccines: the Geneva consensus on essential steps towards clinical development. Vaccine 2005, 23(May (29)):3753-3761.
21. Walker K.B., Brennan M.J., Ho M.M., Eskola J., Thiry G., Sadoff J., et al. The second Geneva consensus: recommendations for novel live TB vaccines. Vaccine 2010, 28(March (11)):2259-2270.
22. Camacho L.R., Ensergueix D., Perez E., Gicquel B., Guilhot C. Identification of a virulence gene cluster of Mycobacterium tuberculosis by signature-tagged transposon mutagenesis. Molecular Microbiology 1999, 34(October (2)):257-267.
23. Cox J.S., Chen B., McNeil M., Jacobs W.R. Complex lipid determines tissue-specific replication of Mycobacterium tuberculosis in mice. Nature 1999, 402(November (6757)):79-83.
24. Jackson M., Raynaud C., Laneelle M.A., Guilhot C., Laurent-Winter C., Ensergueix D., et al. Inactivation of the antigen 85C gene profoundly affects the mycolate content and alters the permeability of the Mycobacterium tuberculosis cell envelope. Molecular Microbiology 1999, 31(March (5)):1573-1587.
25. Malaga W., Perez E., Guilhot C. Production of unmarked mutations in mycobacteria using site-specific recombination. FEMS Microbiology Letters 2003, 219(February (2)):261-268.
26. Jackson M., Camacho L.R., Gicquel B., Guilhot C. Mycobacterium tuberculosis protocols. Gene replacement and transposon delivery using the negative selection marker sacB 2001, 59-75. Humana Press, Totowa. T. Parish, N.G. Stocker (Eds.).
27. Pelicic V., Jackson M., Reyrat J.M., Jacobs W.R., Gicquel B., Guilhot C. Efficient allelic exchange and transposon mutagenesis in Mycobacterium tuberculosis. Proceedings of the National Academy of Sciences of the United States of America 1997, 94(September (20)):10955-10960.
28. Constant P., Perez E., Malaga W., Laneelle M.A., Saurel O., Daffe M., et al. Role of the pks15/1 gene in the biosynthesis of phenolglycolipids in the Mycobacterium tuberculosis complex. Evidence that all strains synthesize glycosylated p-hydroxybenzoic methyl esters and that strains devoid of phenolglycolipids harbor a frameshift mutation in the pks15/1 gene. Journal of Biological Chemistry 2002, 277(October (41)):38148-38158.
29. Williams A., Hatch G.J., Clark S.O., Gooch K.E., Hatch K.A., Hall G.A., et al. Evaluation of vaccines in the EU TB Vaccine Cluster using a guinea pig aerosol infection model of tuberculosis. Tuberculosis (Edinb) 2005, 85(January-March (1-2)):29-38.
30. Williams A., Davies A., Marsh P.D., Chambers M.A., Hewinson R.G. Comparison of the protective efficacy of bacille calmette-Guerin vaccination against aerosol challenge with Mycobacterium tuberculosis and Mycobacterium bovis. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America 2000, 30(June (Suppl. 3)):S299-S301.
31. Commission EP Freeze-dried BCG vaccine. European pharmacopoeia 2008, Council of Europe, Strasbourg. 6th ed.
32. WHO. Expert Committee on Biological Standardization Geneva, 17 to 21 October 2011. Recommendations to Assure the Quality, Safety and Efficacy of BCG Vaccines. Proposed replacement of: TRS 745, Annex 2 and Amendment to TRS 771, Annex 12. WHO/BS/2011.2157 ENGLISH ONLY; 2011.
33. Mahmoud A. The future of vaccine discovery and development. Vaccines: a biography 2010, 375-385. Springer, New York.
34. Brosch R., Gordon S.V., Marmiesse M., Brodin P., Buchrieser C., Eiglmeier K., et al. A new evolutionary scenario for the Mycobacterium tuberculosis complex. Proceedings of the National Academy of Sciences of the United States of America 2002, 99(March (6)):3684-3689.
35. Grode L., Ganoza C.A., Brohm C., Weiner J., Eisele B., Kaufmann S.H. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine 2013, 31(February (9)):1340-1348.
36. Tameris M.D., Hatherill M., Landry B.S., Scriba T.J., Snowden M.A., Lockhart S., et al. Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial. Lancet 2013, 381(9871):1021-1028.
37. Nambiar J.K., Pinto R., Aguilo J.I., Takatsu K., Martin C., Britton W.J., et al. Protective immunity afforded by attenuated, PhoP-deficient Mycobacterium tuberculosis is associated with sustained generation of CD4(+) T-cell memory. European Journal of Immunology 2012, 42(February (2)):385-392.
38. Orme I.M. The Achilles heel of BCG. Tuberculosis (Edinb) 2010, 90(November (6)):329-332.