BCG Vaccine and New Tuberculosis Vaccines Against Mycobacterium tuberculosis: A review

Öz

Mycobacterium tuberculosis (M. tuberculosis) causes tuberculosis (TB) which is a serious infectious disease. Bacteria are spread from person to person through tiny droplets released into the air via sneezing and coughing. Despite global efforts to control TB, the disease is the second most common cause of death after Acquired Immune Deficiency Syndrome (AIDS). Currently, Bacillus Calmette-Guérin (BCG) vaccine is used to prevent tuberculous meningitis and miliary disease, particularly in young children, but its protective efficacy is variable in adults. Therefore, there is an urgent need for the development of alternative TB vaccines. Recently, new TB vaccine development efforts have been advanced in different clinical studies. Most of these vaccines are live-attenuated or recombinant mycobacterium, live viral vector-based, and protein/adjuvant vaccines. This review explains the recapitulation of the current status of new TB vaccines updated with scientific literature references.

Anahtar Kelimeler

• Mycobacterium tuberculosis,new vaccines,clinical studies,BCG,review

Kaynakça

1. Arbues, A., Aguilo, J. I., Gonzalo-Asensio, J., Marinova, D., Uranga, S., Puentes, E., Fernandez, C., Parra, A., Cardona, P. J., Vilaplana, C., Ausina, V., Williams, A., Clark, S., Malaga, W., Guilhot, C., Gicquel, B., Martin, C. (2013). Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis based vaccine to enter clinical trials. Vaccine, 31(42), 4867–4873. Doi: 10.1016/j.vaccine.2013.07.051.
2. Baldwin, S. L., Bertholet, S., Reese, V. A., Ching, L. K., Reed, S. G., Coler, R. N. (2012). The importance of adjuvant formulation in the development of a tuberculosis vaccine. The Journal of Immunology, 188(5), 2189-2197. Doi: 10.4049/jimmunol.1102696.
3. Barry, K., Ming, W., Yan, G., Johanna, G., Kamalakannan, P., Lewis, V., Schrager, K. (2016). Novel approaches to preclinical research and TB vaccine development. Tuberculosis, 99, 12-15. https://doi.org/10.1016/j.tube.2016.05.012
4. Cardona, P. J. (2006). RUTI: A new chance to shorten the treatment of latent tuberculosis infection. Tuberculosis, 86, 273–289. https://doi.org/10.1016/j.tube.2006.01.024.
5. Clark, S., Lanni, F., Marinova, D., Rayner, E., Martin, C., Williams, A. (2017). Revaccination of Guinea pigs with the live attenuated Mycobacterium tuberculosis vaccine MTBVAC improves BCG’s protection against tuberculosis. Journal Infectious Disease, 216(5), 525-533. https://doi.org/10.1093/infdis/jix030
6. Daniel, T. M. (2006). The history of tuberculosis. Respiratory Medicine, 100(11), 1862-1870. http://dx.doi.org/10.1016/j.rmed.2006.08.006
7. Dockrell, H. M. (2016). Towards new TB vaccines: what are the challenges? Pathogens Disease, 74, 1-7. Doi: 10.1093/femspd/ftw016
8. Frick, M. (2015). The tuberculosis vaccines pipeline: a new path to the same destination? In: Pipeline report HIV, hepatitis C virus and tuberculosis drugs, diagnostics, vaccines, preventive technologies towards a cure and immune-based and gene therapies in development. Anderea, B., (eds.). HIV i-Base/Treatment action group. 163-178.

9. Gopal, R., Khader, S. A. (2013). Vaccines against tuberculosis: moving forward with new concepts. Expert Review of Vaccines, 12(8), 829-831. Doi:10.1586/14760584.2013.814836.
10. Gupta, A., Ahmad, F. J., Ahmad, F., Gupta, U. D., Natarajan, M., Katoch, V. M., Bhaskar, S. (2012). Protective efficacy of Mycobacterium indicus pranii against tuberculosis and underlying local lung immune responses in Guinea pig model. Vaccine, 30(43), 6198-6209. Doi: 10.1016/j.vaccine.2012.07.061.
11. Hawkridge, T., Mahomed, H. (2011). Prospects for a new, safer and more effective TB vaccine. Paediatric Respiratory Reviews, 12(1), 46-51. https://doi.org/10.1016/j.prrv.2010.09.013
12. Hesseling, A. C., Marais, B. J., Gie, R. P., Schaaf, H. S., Fine, P. E., Godfrey-Faussett, P., Beyers, N. (2007). The risk of disseminated Bacille Calmette-Guérin (BCG) disease in HIV-infected children. Vaccine, 25(1), 14-18. Doi: 10.1016/j.vaccine.2006.07.020
13. Hussey, G., Hawkridge., T, Hanekom, W. (2007). Childhood tuberculosis: old and new vaccines. Paediatric Respiratory Reviews, 8(2), 148–154. Doi:10.1016/j. prrv.2007.04.009.
14. Kamal, R., Pathak, V., Kumari, A., Natrajan, M., Katoch, K., Kar, H. K. (2016). Addition of Mycobacterium indicus pranii (MIP) vaccine as an immunotherapeutic with standard chemotherapy in borderline leprosy: a doubleblind study to assess clinical improvement (A preliminary report). British Journal of Dermatology, http://dx.doi.org/10.1111/bjd.14971
15. Kamath, A. T., Rochat, A. F., Valenti, M. P., Agger, E. M., Lingnau, K., Andersen, P., Lambert, P. H., Siegrist, C. A. (2008). Adult-like antimycobacterial T cell and in vivo dendritic cell responses following neonatal immunization with Ag85B-ESAT-6 in the IC31® adjuvant. PLoS One, 3(11), 1-10. https://doi.org/10.1371/journal.pone.0003683.
16. Kaufmann, S. H. E., Weiner, J., von Reyn, C. F. (2017). Novel approaches to tuberculosis vaccine development. International Journal of Infectious Diseases, 56, 263–267. Doi: 10.1016/j.ijid.2016.10.018.
17. Khoshnood, S., Heidary, M., Haeili, M., Drancourt, M., Sarokhalil, D. D., Nasiri, M. J., Lohrasbi, V. (2018). Novel vaccine candidates against Mycobacterium tuberculosis. International Journal of Biological Macromolecules, 120, 180–188. Doi: 10.1016/j.ijbiomac.2018.08.037.
18. Leroux-Roels, H., Forgus, S., De Boever, F., Clement, F., Demoitié, M. A., Mettens, P., Moris, P., Ledent, E., Leroux-Roels, G., Ofori-Anyinam, O., M72 Study Group. (2013). Improved CD4+T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations: a randomized trial. Vaccine, 31(17), 2196-2206. Doi: 10.1016/j.vaccine.2012.05.035.
19. Luabeya, A. K., Kagina, B. M., Tameris, M. D., Geldenhuys, H., Hoff, S. T., Shi, Z., Kromann, I., Hatherill, M., Mahomed, H., Hanekom, W. A., Andersen, P., Scriba, T. J., H56-032 Trial Study Group. (2015). First-inhuman trial of the postexposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults. Vaccine, 33(33), 4130–4140. Doi: 10.1016/j.vaccine.2015.06.051.
20. Montagnani, C., Chiappini, E., Galli, L., de Martino, M. (2014). Vaccine against tuberculosis: what’s new? BMC Infectious Diseases, 14, 1-9. https://doi.org/10.1186/1471-2334-14-S1-S2.
21. Nieuwenhuizen, N. E., Kulkarni, P. S., Shaligram, U., Cotton, M. F., Rentsch, C. A., Eisele, B., Grode, L., Kaufmann, S. H. E. (2017). The Recombinant Bacille Calmette– Guérin Vaccine VPM1002: ready for clinical efficacy testing. Frontiers in Immunology, 8, 1147. Doi: 10.3389/fimmu.2017.01147
22. Orme, I. M. (2013). Vaccine development for tuberculosis: current progress. Drugs, 73(10), 1015-1024. Doi:10.1007/s40265-013-0081-8.
23. Orme, I. M. (2015). Tuberculosis vaccine types and timings. Clinical and Vaccine Immunology, 22(3), 249-257. https://doi.org/10.1128/CVI.00718-14.
24. Panga, Y., Zhaoc, A., Kanga, C. C. W., Lue, J., Wangc, G., Zhaob, Y., Zhenga, S. (2016). Current status of new tuberculosis vaccine in children. Human Vaccine Immunotherapeutics, 12(4), 960–970. http://dx.doi.org/10.1080/21645515.2015.1120393
25. Penn-Nicholson, A., Tameris, M., Smit, E., Day, T. A., Musvosvi, M., Jayashankar, L., Vergara, J., Mabwe, S., Bilek, N., Geldenhuys, H., Luabeya, A. K., Ellis, R., Ginsberg, A. M., Hanekom, W. A., Reed, S. G., Coler, R. N., Scriba, T. J., Hatherill, M., TBVPX-114 study team. (2018). Safety and immunogenicity of the novel tuberculosis vaccine ID93/GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomized, double-blind, placebo-controlled phase 1 trial. Lancet Respiratory Medicine, 6(4), 287-298. Doi: 10.1016/S2213-2600(18)30077-8.
26. Safrit, J. T., Fast, P. E., Gieber, L., Kuipers, H., Dean, H. J., Koff, W. C. (2016). Status of vaccine research and development of vaccines for HIV-1. Vaccine, 34(26), 2921-2925. https://doi.org/10.1016/j.vaccine.2016.02.074.
27. Schito, M., Migliori, G. B., Fletcher, H. A., McNerney, R., Rosella, C., D’Ambrosio, L., Bates, M., Kibiki, G., Kapata, N., Corrah, T., Bomanji, J., Vilaplana, C., Johnson, D., Mwaba, P., Maeurer, M., Zumla, A. (2015). Perspectives in advances in tuberculosis diagnostics, drugs, and vaccines. Clinical Infectious Diseases, 61(suppl 3), 102-118. Doi: 10.1093/cid/civ609
28. Schrager, L. K., Harris, R. C., Vekemans, J. (2019). Research and development of new tuberculosis vaccines: a review (version 2; referees 3 approved, 1 approved with reservations), F1000 Research, 7, 173. https://doi.org/10.12688/f1000research.16521.2
29. Sharma, S. K., Katoch, K., Sarin, R., Balambal, R., Jain, N. K., Patel, N., Murthy, K. J. R., Singla, N., Saha, P. K., Khanna, A. (2017). Efficacy and safety of mycobacterium indicus pranii as an adjunct therapy in category II pulmonary tuberculosis in a randomized trial. Scientific Report, 7(1), 1-12. https://doi.org/10.1038/s41598-017-03514-1.
30. Soundarya, J. S. V. Ranganathan, U. D., Tripathy, S. P. (2019). Current trends in tuberculosis vaccine. Medical Journal Armed Forces India 75, 18-24. Doi:10.1016/j.mjafi.2018.12.013.
31. Spertini, F., Audran, R., Chakour, R., Karoui ,O., Steiner-Monard, V., Thierry, A. C., Mayor, C. E., Rettby, N., Jaton, K., Vallotton, L., Lazor-Blanchet, C., Doce, J., Puentes, E., Marinova, D., Aguilo, N., Martin, C. (2015). Safety of human immunization with a live-attenuated Mycobacterium tuberculosis vaccine: a randomized, double blind, controlled phase I trial. Lancet Respiratory Medicine, 3(12), 953–962. Doi: 10.1016/S2213-2600(15)00435-X.
32. Tameris, M. D., Hatherill, M., Landry, B. S., Scriba,T. J., Snowden, M. A., Lockhart, S., Shea, J. E., McClain, J. B., Hussey, G. D., Hanekom, W. A., Mahomed, H., McShane, H., MVA85A 020 Trial Study Team. (2013). Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomized, placebo-controlled phase 2b trial. Lancet, 381, 1021-1028. Doi: 10.1016/S0140-6736(13)60177-4
33. Tang, J., Yam, W. C., Chen, Z. (2016). Mycobacterium tuberculosis infection and vaccine development. Tuberculosis, 98, 30-41. Doi: 10.1016/j.tube.2016.02.005.
34. Usman, M. M., Ismail, S., Teoh, C. T. (2017). Vaccine research and development: tuberculosis as a global health threat. Central European Journal of Immunology, 42(2), 196-204. https://doi.org/10.5114/ceji.2017.69362
35. Van Der Meeren, O., Hatherill, M., Nduba, V., Wilkinson, R. J., Muyoyeta, M., Van Brakel, E., Ayles, H. M., Henostroza, G., Thienemann, F., Scriba, T. J., Diacon, A., Blatner, G. L., Demoitié, M. A., Tameris, M., Malahleha, M., Innes, J. C., Hellström, E., Martinson, N., Singh, T., Akite, E. J., Khatoon Azam, A., Bollaerts, A., Ginsberg, A. M., Evans, T. G., Gillard, P., Tait, D. R. (2018). Phase 2b controlled trial of M72/AS01E vaccine to prevent tuberculosis. The New England Journal of Medicine, 379, 1621-1634. Doi: 10.1056/NEJMoa1803484
36. Vilaplana, C., Gil, O., Caceres, N., Pinto, S., Dıaz, J., Cardona, P. J. (2011). Prophylactic effect of a therapeutic vaccine against TB based on fragments of Mycobacterium tuberculosis. PLoS One, 6(5), 2-6. https://doi. org/10.1371/journal.pone.0020404.
37. Vilaplana, C., Montané, E., Pinto, S., Barriocanal, A. M., Domenech, G., Torres, F., Cardona, P. J., Costa, J. (2010). Double-blind, randomized, placebo controlled Phase I clinical trial of the therapeutical antituberculous vaccine RUTI. Vaccine, 28(4), 1106–1116. Doi: 10.1016/j.vaccine.2009.09.134.
38. Von Reyn, C. F., Mtei, L., Arbeit, R. D., Waddell, R., Cole, B., Mackenzie, T., Matee, M., Bakari, M., Tvaroha, S., Adams, L. V., Horsburgh, C. R., Pallangyo, K., Dar Study Group. (2010). Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. AIDS, 24, 675–685. Doi: 10.1097/QAD.0b013e3283350f1b.
39. Vuola, J. M., Ristola, M. A., Cole, B., Jarviluoma, A., Tvaroha, S., Ronkko, T., Rautio, O., Arbeit, R. D., von Reyn, C. F. (2003). Immunogenicity of an inactivated mycobacterial vaccine for the prevention of HIV-associated tuberculosis: a randomized, controlled trial. AIDS, 17, 2351–2355. Doi: 10.1097/00002030-200311070-00010.
40. World Health Organization, Biologicals, BCG vaccine. https://www.who.int/biologicals/areas/vaccines/bcg/en/ (accessed 24 October 2019).
41. World Health Organization (2012), Global Tuberculosis Report: Geneva, Switzerland. https://www.who.int/tb/publications/global_report/gtbr12_main.pdf (accessed 16 November 2019).
42. World Health Organization (2015), Tuberculosis (TB): the end TB strategy. Geneva, Switzerland. http://www.who.int/tb/strategy/end-tb/en/ (accessed 16 November 2019).
43. World Health Organization (2018), Global Tuberculosis Report: Geneva, Switzerland. https://www.who.int/tb/publications/global_report/gtbr2018_main_text_28Feb2019.pdf (accessed 16 November 2019).
44. Zwerling, A., Behr, M. A., Verma, A. Brewer, T. F., Menzies, D., Pai, M. (2011). The BCG World Atlas: a database of global BCG vaccination policies and practices. PLoS Med, 8, 1001-1012. http://dx.doi. org/10.1371/journal.pmed.1001012.