Abstract:Tuberculosis (TB) is an infectious disease. So far, the only vaccine approved for TB prevention is the BCG. BCG vaccine made from Mycobacterium bovis in more than 100 years ago, can prevent TB infection in children. Since BCG function is of cellular immunity and lack of immunogenicity, it can’t prevent TB infection in adults. In addition, the number of multidrug-resistant TB (MDR-TB) infections is increasing, the global reduction in the incidence and mortality of TB infections still falls short of the World Health Organization (WHO) target. Therefore, a new and effective TB vaccine as well as a basic-enhanced immunization strategy is needed to replace BCG in the prevention of TB infection. In this review, we summarize the clinical candidate vaccines for prophylactic and therapeutic functions, with the aim of making us to understand more situations about the prevention and control of TB.
张智芳, 严延生. 预防与治疗性结核病疫苗的研究进展[J]. 中国人兽共患病学报, 2018, 34(11): 1033-1039.
ZHANG Zhi-fang, YAN Yan-sheng. Research progress of prophylactic and therapeutic tuberculosis vaccines. Chinese Journal of Zoonoses, 2018, 34(11): 1033-1039.
[1] Paulson T.Epidemiology: a mortal foe[J]. Nature, 2013;502(7470):S2-S3. DOI:10.1038/502S2a
[2] World Health Organization. Global Tuberculosis Report (2017).[2018-07-04].2017).[2018-07-04].http://www.who.int/iris/handle/10665/259366
[3] Havlir DV, Getahun H, Sanne I,et al.Opportunities and challenges for HIV care in overlapping HIV and TB epidemics[J]. JAMA, 2008,300(4):423-430. DOI: 10.1001/jama.300.4.423
[4] Ai JW, Ruan QL, Liu QH, et al.Updates on the risk factors for latent tuberculosis reactivation and their managements[J]. Emerg Microbes Infect ,2016, 5:e10. DOI:10.1038/emi.2016.10
[5] Mazurek GH, LoBue PA, Daley CL,et al.Comparison of a whole-blood interferon gamma assay with tuberculin skin testing for detecting latent Mycobacterium tuberculosis infection[J]. JAMA,2001,286(14):1740-1747.
[6] Kolloli A, Subbian S.Host-directed therapeutic strategies for tuberculosis[J]. Front Med (Lausanne) ,2017,4:171. DOI: 10.3389/fmed.2017.00171
[7] Pontali E, Sotgiu G, D'Ambrosio L, et al. Bedaquiline and multidrug-resistant tuberculosis: a systematic and critical analysis of the evidence[J]. Eur Respir J, 2016,47(2):394-402. DOI:10.1183/13993003.01891-2015
[8] Agyeman AA, Ofori-Asenso R.Efficacy and safety profile of linezolid in the treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis: a systematic review and meta-analysis[J]. Ann Clin Microbiol Antimicrob,2016, 15(1):41. DOI:10.1186/s12941-016-0156-y
[9] Napier RJ, Norris BA, Swimm A, et al.Low doses of imatinib induce myelopoiesis and enhance host anti-microbial immunity[J]. PLoS Pathog,2015,11(3):e1004770. DOI:10.1371/journal.ppat.1004770
[10] Singhal A, Jie L, Kumar P, et al. Metformin as adjunct antituberculosis therapy[J]. Sci Transl Med,2014, 6(263)263ra159. DOI: 10.1126/scitranslmed.3009885
[11] Verreck FA, Tchilian EZ, Vervenne RA, et al.Variable BCG efficacy in rhesus populations: pulmonary BCG provides protection where standard intra-dermal vaccination fails[J]. Tuberculosis (Edinb),2017,104:46-57. DOI:10.1016/j.tube.2017.02.003
[12] Grode L, Ganoza CA, Brohm C, et al.Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial[J]. Vaccine, 2013,31(9):1340-1348. DOI:10.1016/j.vaccine.2012.12.053
[13] Nieuwenhuizen NE, Kulkarni PS, Shaligram U, et al.The recombinant Bacille Calmette-Guerin vaccine VPM1002: ready for clinical efficacy testing[J]. Front Immunol,2017,8:1147. DOI:10.3389/fimmu.2017.01147
[14] Geoffroy C, Gaillard JL, Alouf JE, et al.Purification, characterization, and toxicity of the sulfhydryl-activated hemolysin listeriolysin O from Listeria monocytogenes[J]. Infect Immun,1987,55(7):1641-1646.
[15] Loxton AG, Knaul JK, Grode L,et al.Safety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa[J]. Clin Vaccine Immunol, 2017, 24(2): e00439-16. DOI:10.1128/CVI.00439-16
[16] Moliva JI, Turner J, Torrelles JB.Prospects in Mycobacterium bovis Bacille Calmette et Guerin (BCG) vaccine diversity and delivery: why does BCG fail to protect against tuberculosis[J]. Vaccine,2015,33(39):5035-5041. DOI:10.1016/j.vaccine.2015.08.033
[17] Fletcher HA, Schrager L.TB vaccine development and the end TB strategy: importance and current status[J]. Trans R Soc Trop Med Hyg, 2016,110(4):212-218. DOI:10.1093/trstmh/trw016
[18] Gonzalo-Asensio J, Marinova D, Martin C, et al.MTBVAC: Attenuating the Human Pathogen of Tuberculosis (TB) Toward a Promising Vaccine against the TB Epidemic[J]. Front Immunol,2017 ,8:1803. DOI:10.3389/fimmu.2017.01803
[19] Perez-Martinez AP, Ong E, Zhang L,et al.Conservation in gene encoding Mycobacterium tuberculosis antigen Rv2660 and a high predicted population coverage of H56 multistage vaccine in South Africa[J]. Infect Genet Evol, 2017,55:244-250. DOI: 10.1016/j.meegid.2017.09.023
[20] Meher AK, Bal NC, Chary KV, et al.Mycobacterium tuberculosis H37Rv ESAT-6-CFP-10 compleand biochemical stability[J]. FEBS J,2006, 273(7): 1445-1462. DOI:10.1111/j.1742-4658.2006.05166.x
[21] Brandt L, Elhay M, Rosenkrands I, et al.ESAT-6 subunit vaccination against Mycobacterium tuberculosis[J] . Infect Immun, 2000,68(2):791-795.
[22] Marie-Cecile M, Erik J, Pascal M,et al.Sequence conservation analysis and in silico human leukocyte antigen-peptide binding predictions for the Mtb72F and M72 tuberculosis candidate vaccine antigens[J]. BMC Immunology,2015,16:63. DOI 10.1186/s12865-015-0119-7
[23] Fishbein S, van Wyk N, Warren RM, et al.Phylogeny to function: PE/PPE protein evolution and impact on Mycobacterium tuberculosis pathogenicity[J]. Mol Microbiol,2015,96(5):901-916. DOI: 10.1111/mmi.12981
[24] van Dissel JT, Joosten SA, Hoff ST,et al. A novel liposomal adjuvant system, CAF01, promotes long-lived Mycobacterium tuberculosis-specific T-cell responses in human[J]. Vaccine, 2014,32(52):7098-7107. DOI: 10.1016/j.vaccine.2014.10.036
[25] Reither K, Katsoulis L, Beattie T, et al.Safety and immunogenicity of H1/IC31(R), an adjuvanted TB subunit vaccine, in HIV-infected adults with ${CD}_{4}^{+}$ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial[J]. PLoS One,2014,9(12):e114602. DOI:10.1371/journal.pone.0114602
[26] Mearns H, Geldenhuys HD, Kagina BM, et al.H1:IC31 vaccination is safe and induces long-lived TNF-alpha+IL-2+CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: a randomized trial[J]. Vaccine,2017,35(1):132-141. DOI:10.1016/j.vaccine.2016.11.023
[27] Luabeya AK, Kagina BM, Tameris MD, et al.First-in-human trial of the post-exposure tuberculosis vaccine H56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults[J]. Vaccine, 2015,33(33):4130-4140. DOI:10.1016/j.vaccine.2015.06.051
[28] Billeskov R, Elvang TT, Andersen PL, et al.The HyVac4 subunit vaccine efficiently boosts BCG-primed anti-mycobacterial protective immunity[J]. PLoS One,2012,7(6):e39909. DOI:10.1371/journal.pone.0039909
[29] Skeiky YA, Dietrich J, Lasco TM, et al.Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime-boost regimen[J]. Vaccine,2010,28(4):1084-1093. DOI:10.1016/j.vaccine.2009.10.114
[30] Billeskov R1, Elvang TT, Andersen PL, et al. The HyVac4 subunit vaccine efficiently boosts BCG-primed anti-mycobacterial protective immunity[J].PLoS One, 2012,7(6):e39909. DOI: 10.1371/journal.pone.0039909
[31] Penn-Nicholson A, Geldenhuys H, Burny W, et al.Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting[J].Vaccine, 2015,33(32):4025-34. DOI: 10.1016/j.vaccine.2015.05.088. Epub 2015 Jun 10
[32] Coler RN, Bertholet S, Pine SO, et al.Therapeutic immunization against Mycobacterium tuberculosis is an effective adjunct to antibiotic treatment[J]. J Infect Dis, 2013, 207(8):1242-1252. DOI: 10.1093/infdis/jis425
[33] Dockrell HM. Towards new TB vaccines: what are the challenges[J]. Pathog Dis, 2016,74(4):ftw016. DOI:10.1093/femspd/ftw016
[34] Tameris MD, Hatherill M, Landry BS, et al.Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial[J]. Lancet,2013, 381(9871):1021-1028. DOI:10.1016/S0140-6736(13)60177-4
[35] Satti I, Meyer J, Harris SA, et al.Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial[J]. Lancet Infect Dis, 2014 ,14(10): 939-946. DOI:10.1016/S1473-3099(14)70845-X
[36] van Zyl-Smit RN, Esmail A, Bateman ME, et al. Safety and immunogenicity of adenovirus 35 tuberculosis vaccine candidate in adults with active or previous tuberculosis. A randomized trial[J]. Am J Respir Crit Care Med,2017,195(9):1171-1180. DOI:10.1164/rccm.201603-0654OC
[37] Whole Mycobacteria Cell Vaccines for Tuberculosis Summary Group. Developing whole mycobacteria cell vaccines for tuberculosis: Workshop proceedings, Max Planck Institute for Infection Biology, Berlin, Germany, July 9, 2014[J]. Vaccine,2015, 33(26):3047-3055. DOI:10.1016/j.vaccine.2015.03.056
[38] von Reyn CF, Lahey T, Arbeit RD, et al. Safety and immunogenicity of an inactivated whole cell tuberculosis vaccine booster in adults primed with BCG: A randomized, controlled trial of DAR-901[J]. PLoS One, 2017,12(5):e0175215. DOI:10.1371/journal.pone.0175215
[39] He L, Su J, Ming M, et al.Flow cytometry: an efficient method for antigenicity measurement and particle characterization on an adjuvanted vaccine candidate H4-IC31 for tuberculosis[J]. J Immunol Methods ,2018,452:39-45. DOI:10.1016/j.jim.2017.10.005
[40] Neeland MR, Shi W, Collignon C, et al.The lymphatic immune response induced by the adjuvant AS01: a comparison of intramuscular and subcutaneous immunization routes[J]. J Immunol ,2016,197(7):2704-2714. DOI:10.4049/jimmunol.1600817
[41] Detienne S, Welsby I, Collignon C, et al.Central role of ${CD}_{169}^{+}$lymph node resident macrophages in the adjuvanticity of the QS-21 component of AS01[J]. Sci Rep, 2016,6:39475. DOI:10.1038/srep39475
[42] Gillard P, Yang PC, Danilovits M, et al.Safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in adults with tuberculosis: a phase II randomised study[J]. Tuberculosis (Edinb) ,2016,100:118-127. DOI:10.1016/j.tube.2016.07.005
[43] Rose F, Wern JE, Ingvarsson PT, et al.Engineering of a novel adjuvant based on lipid-polymer hybrid nanoparticles: a quality-by-design approach[J]. J Control Release, 2015,210:48-57. DOI:10.1016/j.jconrel.2015.05.004
[44] Cha SB, Kim WS, Kim JS, et al.Pulmonary immunity and durable protection induced by the ID93/GLA-SE vaccine candidate against the hyper-virulent Korean Beijing Mycobacterium tuberculosis strain K[J]. Vaccine, 2016,34(19):2179-2187. DOI:10.1016/j.vaccine.2016.03.029
[45] Méndez-Samperio P.Global efforts in the development of vaccines for tuberculosis: requirements for improved vaccines against Mycobacterium tuberculosis[J]. Scand J Immunol ,2016,84(4):204-210. DOI:10.1111/sji.12465
[46] Butov DA, Pashkov YN, Stepanenko AL, et al.Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB[J]. J Immune Based Ther,Vaccines, 2011,9:3. DOI:10.1186/1476-8518-9-3
[47] Xing Z, McFarland CT, Sallenave JM, et al. Intranasal mucosal boosting with an adenovirus-vectored vaccine markedly enhances the protection of BCG-primed guinea pigs against pulmonary tuberculosis[J]. PLoS One,2009, 4(6):e5856. DOI:10.1371/journal.pone.0005856
[48] Smaill F, Jeyanathan M, Smieja M, et al. A human type 5 adenovirus-based tuberculosis vaccine induces robust T cell responses in humans despite preexisting anti-adenovirus immunity[J]. Sci Transl Med,2013,5(205):205ra134. DOI:10.1126/scitranslmed.3006843
[49] Lalvani A, Sridhar S, von Reyn CF. Tuberculosis vaccines: time to reset the paradigm[J].Thorax, 2013,68(12):1092-1094. DOI: 10.1136/thoraxjnl-2013-203456.
[50] Rodrigues LC, Pereira SM, Cunha SS, et al. Effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: the BCG-REVAC cluster-randomised trial[J]. Lancet, 2005, 366(9493):1290-1295. Epub 2005/10/11. DOI: 10.1016/S0140-6736(05)67145-0
[51] 王洪海. 全球结核病疫苗研究进展[J]. 微生物与感染, 2017, 12:198-205.