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Review

Current status of new tuberculosis vaccine in children

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Pages 960-970 | Received 01 Jul 2015, Accepted 11 Nov 2015, Published online: 22 Mar 2016

References

  • Swaminathan S, Rekha B. Pediatric tuberculosis: global overview and challenges. Clin Infect Dis 2010; 50(Suppl 3):S184-94; PMID:20397947; http://dx.doi.org/10.1086/651490
  • Sandgren A, Cuevas LE, Dara M, Gie RP, Grzemska M, Hawkridge A, Hesseling AC, Kampmann B, Lienhardt C, Manissero D, et al. Childhood tuberculosis: progress requires an advocacy strategy now. Eur Respir J 2012; 40:294-7; PMID:22337859; http://dx.doi.org/10.1183/09031936.00187711
  • Marais BJ, Pai M. New approaches and emerging technologies in the diagnosis of childhood tuberculosis. Paediatr Respir Rev 2007; 8:124-33; PMID:17574156; http://dx.doi.org/10.1016/j.prrv.2007.04.002
  • Marais BJ, Schaaf HS. Childhood tuberculosis: an emerging and previously neglected problem. Infect Dis Clin North Am 2010; 24:727-49; PMID:20674801; http://dx.doi.org/10.1016/j.idc.2010.04.004
  • Acosta CD, Rusovich V, Harries AD, Ahmedov S, van den Boom M, Dara M. A new roadmap for childhood tuberculosis. Lancet Glob Health 2014; 2:e15-7; PMID:25104625; http://dx.doi.org/10.1016/S2214-109X(13)70153-0
  • Hamzaoui A, Yaalaoui S, Tritar Cherif F, Slim Saidi L, Berraies A. Childhood tuberculosis: a concern of the modern world. Eur Respir Rev 2014; 23:278-91; PMID:25176964; http://dx.doi.org/10.1183/09059180.00005314
  • Guidance for National Tuberculosis Programmes on the management of tuberculosis in children. Chapter 1: introduction and diagnosis of tuberculosis in children. Int J Tuberc Lung Dis 2006; 10:1091-7; PMID:17044200
  • Kaufmann SH, Hussey G, Lambert PH. New vaccines for tuberculosis. Lancet 2010; 375:2110-9; PMID:20488515; http://dx.doi.org/10.1016/S0140-6736(10)60393-5
  • Chawla S, Garg D, Jain RB, Khanna P, Choudhary S, Sahoo S, Singh I. Tuberculosis vaccine: time to look into future. Hum Vaccin Immunother 2014; 10:420-2; PMID:24231233; http://dx.doi.org/10.4161/hv.27108
  • Svenson S, Kallenius G, Pawlowski A, Hamasur B. Towards new tuberculosis vaccines. Hum Vaccin 2010; 6:309-17; PMID:20372087; http://dx.doi.org/10.4161/hv.6.4.10711
  • Kaufmann SH. Tuberculosis vaccine development: strength lies in tenacity. Trends Immunol 2012; 33:373-9; PMID:22560865; http://dx.doi.org/10.1016/j.it.2012.03.004
  • Principi N, Esposito S. The present and future of tuberculosis vaccinations. Tuberculosis (Edinb) 2015; 95:6-13; PMID:25458613; http://dx.doi.org/10.1016/j.tube.2014.10.004
  • Hong CY, Wang F, Gui J, Liu XL. [Characteristics of pncA gene in multidrug-resistant Mycobacterium tuberculosis isolates and its correlation with drug resistance to pyrazinamide]. Zhonghua Yu Fang Yi Xue Za Zhi 2012; 46:436-9; PMID:22883731
  • Soysal A, Millington KA, Bakir M, Dosanjh D, Aslan Y, Deeks JJ, Efe S, Staveley I, Ewer K, Lalvani A. Effect of BCG vaccination on risk of Mycobacterium tuberculosis infection in children with household tuberculosis contact: a prospective community-based study. Lancet 2005; 366:1443-51; PMID:16243089; http://dx.doi.org/10.1016/S0140-6736(05)67534-4
  • Eriksen J, Chow JY, Mellis V, Whipp B, Walters S, Abrahamson E, Abubakar I. Protective effect of BCG vaccination in a nursery outbreak in 2009: time to reconsider the vaccination threshold? Thorax 2010; 65:1067-71; PMID:21030395; http://dx.doi.org/10.1136/thx.2010.140186
  • Trunz BB, Fine P, Dye C. Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectiveness. Lancet 2006; 367:1173-80; PMID:16616560; http://dx.doi.org/10.1016/S0140-6736(06)68507-3
  • Rodrigues LC, Diwan VK, Wheeler JG. Protective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. Int J Epidemiol 1993; 22:1154-8; PMID:8144299; http://dx.doi.org/10.1093/ije/22.6.1154
  • Fine PE. Variation in protection by BCG: implications of and for heterologous immunity. Lancet 1995; 346:1339-45; PMID:7475776; http://dx.doi.org/10.1016/S0140-6736(95)92348-9
  • Colditz GA, Berkey CS, Mosteller F, Brewer TF, Wilson ME, Burdick E, Fineberg HV. The efficacy of bacillus Calmette-Guerin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature. Pediatrics 1995; 96:29-35; PMID:7596718
  • Mangtani P, Abubakar I, Ariti C, Beynon R, Pimpin L, Fine PE, Rodrigues LC, Smith PG, Lipman M, Whiting PF, et al. Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials. Clin Infect Dis 2014; 58:470-80; PMID:24336911; http://dx.doi.org/10.1093/cid/cit790
  • Pang Y, Kang W, Zhao A, Liu G, Du W, Xu M, Wang G, Zhao Y, Zheng S. The effect of bacille Calmette-Guerin vaccination at birth on immune response in China. Vaccine 2015; 33:209-13; PMID:25454854; http://dx.doi.org/10.1016/j.vaccine.2014.10.030
  • Poyntz HC, Stylianou E, Griffiths KL, Marsay L, Checkley AM, McShane H. Non-tuberculous mycobacteria have diverse effects on BCG efficacy against Mycobacterium tuberculosis. Tuberculosis (Edinb) 2014; 94:226-37; PMID:24572168; http://dx.doi.org/10.1016/j.tube.2013.12.006
  • Harries AD, Zachariah R, Corbett EL, Lawn SD, Santos-Filho ET, Chimzizi R, Harrington M, Maher D, Williams BG, De Cock KM. The HIV-associated tuberculosis epidemic–when will we act? Lancet 2010; 375:1906-19; PMID:20488516; http://dx.doi.org/10.1016/S0140-6736(10)60409-6
  • Azzopardi P, Bennett CM, Graham SM, Duke T. Bacille Calmette-Guerin vaccine-related disease in HIV-infected children: a systematic review. Int J Tuberc Lung Dis 2009; 13:1331-44; PMID:19861003
  • Hesseling AC, Marais BJ, Gie RP, Schaaf HS, Fine PE, Godfrey-Faussett P, Beyers N. The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children. Vaccine 2007; 25:14-8; PMID:16959383; http://dx.doi.org/10.1016/j.vaccine.2006.07.020
  • World Health Organization. Revised BCG vaccination guidelines for infants at risk for HIV infection. Wkly Epidemiol Rec 2007; 82:193-6; PMID:17526121
  • Kaufmann SH. Fact and fiction in tuberculosis vaccine research: 10 years later. Lancet Infect Dis 2011; 11:633-40; PMID:21798463; http://dx.doi.org/10.1016/S1473-3099(11)70146-3
  • Kupferschmidt K. Infectious disease. Taking a new shot at a TB vaccine. Science 2011; 334:1488-90; PMID:22174226; http://dx.doi.org/10.1126/science.334.6062.1488
  • Beresford B, Sadoff JC. Update on research and development pipeline: tuberculosis vaccines. Clin Infect Dis 2010; 50(Suppl 3):S178-83; PMID:20397946; http://dx.doi.org/10.1086/651489
  • Horwitz MA, Harth G, Dillon BJ, Maslesa-Galic S. Recombinant bacillus calmette-guerin (BCG) vaccines expressing the Mycobacterium tuberculosis 30-kDa major secretory protein induce greater protective immunity against tuberculosis than conventional BCG vaccines in a highly susceptible animal model. Proc Natl Acad Sci U S A 2000; 97:13853-8; PMID:11095745; http://dx.doi.org/10.1073/pnas.250480397
  • Horwitz MA, Harth G. A new vaccine against tuberculosis affords greater survival after challenge than the current vaccine in the guinea pig model of pulmonary tuberculosis. Infect Immun 2003; 71:1672-9; PMID:12654780; http://dx.doi.org/10.1128/IAI.71.4.1672-1679.2003
  • Grode L, Seiler P, Baumann S, Hess J, Brinkmann V, Nasser Eddine A, Mann P, Goosmann C, Bandermann S, Smith D, et al. Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guerin mutants that secrete listeriolysin. J Clin Invest 2005; 115:2472-9; PMID:16110326; http://dx.doi.org/10.1172/JCI24617
  • Grode L, Ganoza CA, Brohm C, Weiner J, 3rd, Eisele B, Kaufmann SH. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine 2013; 31:1340-8; PMID:23290835; http://dx.doi.org/10.1016/j.vaccine.2012.12.053
  • Dussurget O, Pizarro-Cerda J, Cossart P. Molecular determinants of Listeria monocytogenes virulence. Annu Rev Microbiol 2004; 58:587-610; PMID:15487949; http://dx.doi.org/10.1146/annurev.micro.57.030502.090934
  • Desel C, Dorhoi A, Bandermann S, Grode L, Eisele B, Kaufmann SH. Recombinant BCG DeltaureC hly+ induces superior protection over parental BCG by stimulating a balanced combination of type 1 and type 17 cytokine responses. J Infect Dis 2011; 204:1573-84; PMID:21933877; http://dx.doi.org/10.1093/infdis/jir592
  • Farinacci M, Weber S, Kaufmann SH. The recombinant tuberculosis vaccine rBCG DeltaureC::hly(+) induces apoptotic vesicles for improved priming of CD4(+) and CD8(+) T cells. Vaccine 2012; 30:7608-14; PMID:23088886; http://dx.doi.org/10.1016/j.vaccine.2012.10.031
  • Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, et al. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine 2013; 31:4867-73; PMID:23965219; http://dx.doi.org/10.1016/j.vaccine.2013.07.051
  • Nambiar JK, Pinto R, Aguilo JI, Takatsu K, Martin C, Britton WJ, Triccas JA. Protective immunity afforded by attenuated, PhoP-deficient Mycobacterium tuberculosis is associated with sustained generation of CD4+ T-cell memory. Eur J Immunol 2012; 42:385-92; PMID:22105536; http://dx.doi.org/10.1002/eji.201141903
  • Kaufmann SH, Gengenbacher M. Recombinant live vaccine candidates against tuberculosis. Curr Opin Biotechnol 2012; 23:900-7; PMID:22483201; http://dx.doi.org/10.1016/j.copbio.2012.03.007
  • Solans L, Uranga S, Aguilo N, Arnal C, Gomez AB, Monzon M, Badiola JJ, Gicquel B, Martin C. Hyper-attenuated MTBVAC erp mutant protects against tuberculosis in mice. Vaccine 2014; 32:5192-7; PMID:25066740; http://dx.doi.org/10.1016/j.vaccine.2014.07.047
  • Stanford J, Stanford C, Grange J. Immunotherapy with Mycobacterium vaccae in the treatment of tuberculosis. Front Biosci 2004; 9:1701-19; PMID:14977580; http://dx.doi.org/10.2741/1292
  • Dlugovitzky D, Fiorenza G, Farroni M, Bogue C, Stanford C, Stanford J. Immunological consequences of three doses of heat-killed Mycobacterium vaccae in the immunotherapy of tuberculosis. Respir Med 2006; 100:1079-87; PMID:16278080; http://dx.doi.org/10.1016/j.rmed.2005.09.026
  • Groschel MI, Prabowo SA, Cardona PJ, Stanford JL, van der Werf TS. Therapeutic vaccines for tuberculosis–a systematic review. Vaccine 2014; 32:3162-8; PMID:24726245; http://dx.doi.org/10.1016/j.vaccine.2014.03.047
  • Lahey T, Arbeit RD, Bakari M, Horsburgh CR, Matee M, Waddell R, Mtei L, Vuola JM, Pallangyo K, von Reyn CF. Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania. Vaccine 2010; 28:7652-8; PMID:20875492; http://dx.doi.org/10.1016/j.vaccine.2010.09.041
  • 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. Vaccine 2015; 33:3047-55; PMID:25882170; http://dx.doi.org/10.1016/j.vaccine.2015.03.056
  • Johnson JL, Kamya RM, Okwera A, Loughlin AM, Nyole S, Hom DL, Wallis RS, Hirsch CS, Wolski K, Foulds J, et al. Randomized controlled trial of Mycobacterium vaccae immunotherapy in non-human immunodeficiency virus-infected ugandan adults with newly diagnosed pulmonary tuberculosis. The Uganda-Case Western Reserve University Research Collaboration. J Infect Dis 2000; 181:1304-12; PMID:10753731; http://dx.doi.org/10.1086/315393
  • da Costa C, Walker B, Bonavia A. Tuberculosis vaccines–state of the art, and novel approaches to vaccine development. Int J Infect Dis 2015; 32:5-12; PMID:25809749; http://dx.doi.org/10.1016/j.ijid.2014.11.026
  • McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med 2004; 10:1240-4; PMID:15502839; http://dx.doi.org/10.1038/nm1128
  • Vordermeier HM, Villarreal-Ramos B, Cockle PJ, McAulay M, Rhodes SG, Thacker T, Gilbert SC, McShane H, Hill AV, Xing Z, et al. Viral booster vaccines improve Mycobacterium bovis BCG-induced protection against bovine tuberculosis. Infect Immun 2009; 77:3364-73; PMID:19487476; http://dx.doi.org/10.1128/IAI.00287-09
  • Whelan KT, Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Hill AV, McShane H. Safety and immunogenicity of boosting BCG vaccinated subjects with BCG: comparison with boosting with a new TB vaccine, MVA85A. PLoS One 2009; 4:e5934; PMID:19529780; http://dx.doi.org/10.1371/journal.pone.0005934
  • Goonetilleke NP, McShane H, Hannan CM, Anderson RJ, Brookes RH, Hill AV. Enhanced immunogenicity and protective efficacy against Mycobacterium tuberculosis of bacille Calmette-Guerin vaccine using mucosal administration and boosting with a recombinant modified vaccinia virus Ankara. J Immunol 2003; 171:1602-9; PMID:12874255; http://dx.doi.org/10.4049/jimmunol.171.3.1602
  • Williams A, Goonetilleke NP, McShane H, Clark SO, Hatch G, Gilbert SC, Hill AV. Boosting with poxviruses enhances Mycobacterium bovis BCG efficacy against tuberculosis in guinea pigs. Infect Immun 2005; 73:3814-6; PMID:15908420; http://dx.doi.org/10.1128/IAI.73.6.3814-3816.2005
  • Scriba TJ, Tameris M, Mansoor N, Smit E, van der Merwe L, Mauff K, Hughes EJ, Moyo S, Brittain N, Lawrie A, et al. Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants. J Infect Dis 2011; 203:1832-43; PMID:21606542; http://dx.doi.org/10.1093/infdis/jir195
  • Pathan AA, Minassian AM, Sander CR, Rowland R, Porter DW, Poulton ID, Hill AV, Fletcher HA, McShane H. Effect of vaccine dose on the safety and immunogenicity of a candidate TB vaccine, MVA85A, in BCG vaccinated UK adults. Vaccine 2012; 30:5616-24; PMID:22789508; http://dx.doi.org/10.1016/j.vaccine.2012.06.084
  • Ndiaye BP, Thienemann F, Ota M, Landry BS, Camara M, Dieye S, Dieye TN, Esmail H, Goliath R, Huygen K, et al. Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trial. Lancet Respir Med 2015; 3:190-200; PMID:25726088; http://dx.doi.org/10.1016/S2213-2600(15)00037-5
  • Tameris MD, Hatherill M, Landry BS, Scriba TJ, Snowden MA, Lockhart S, Shea JE, McClain JB, Hussey GD, Hanekom WA, 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; 381:1021-8; PMID:23391465; http://dx.doi.org/10.1016/S0140-6736(13)60177-4
  • Satti I, Meyer J, Harris SA, Manjaly Thomas ZR, Griffiths K, Antrobus RD, Rowland R, Ramon RL, Smith M, Sheehan S, 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. Lancet Infect Dis 2014; 14:939-46; PMID:25151225; http://dx.doi.org/10.1016/S1473-3099(14)70845-X
  • Radosevic K, Wieland CW, Rodriguez A, Weverling GJ, Mintardjo R, Gillissen G, Vogels R, Skeiky YA, Hone DM, Sadoff JC, et al. Protective immune responses to a recombinant adenovirus type 35 tuberculosis vaccine in two mouse strains: CD4 and CD8 T-cell epitope mapping and role of gamma interferon. Infect Immun 2007; 75:4105-15; PMID:17526747; http://dx.doi.org/10.1128/IAI.00004-07
  • Vogels R, Zuijdgeest D, van Rijnsoever R, Hartkoorn E, Damen I, de Bethune MP, Kostense S, Penders G, Helmus N, Koudstaal W, et al. Replication-deficient human adenovirus type 35 vectors for gene transfer and vaccination: efficient human cell infection and bypass of preexisting adenovirus immunity. J Virol 2003; 77:8263-71; PMID:12857895; http://dx.doi.org/10.1128/JVI.77.15.8263-8271.2003
  • Abel B, Tameris M, Mansoor N, Gelderbloem S, Hughes J, Abrahams D, Makhethe L, Erasmus M, de Kock M, van der Merwe L, et al. The novel tuberculosis vaccine, AERAS-402, induces robust and polyfunctional CD4+ and CD8+ T cells in adults. Am J Respir Crit Care Med 2010; 181:1407-17; PMID:20167847; http://dx.doi.org/10.1164/rccm.200910-1484OC
  • Tameris M, Hokey DA, Nduba V, Sacarlal J, Laher F, Kiringa G, Gondo K, Lazarus EM, Gray GE, Nachman S,et al. A double-blind, randomised, placebo-controlled, dose-finding trial of the novel tuberculosis vaccine AERAS-402, an adenovirus-vectored fusion protein, in healthy, BCG-vaccinated infants. Vaccine 2015; 33:2944-54; PMID:25936724; http://dx.doi.org/10.1016/j.vaccine.2015.03.070
  • Wang J, Thorson L, Stokes RW, Santosuosso M, Huygen K, Zganiacz A, Hitt M, Xing Z. Single mucosal, but not parenteral, immunization with recombinant adenoviral-based vaccine provides potent protection from pulmonary tuberculosis. J Immunol 2004; 173:6357-65; PMID:15528375; http://dx.doi.org/10.4049/jimmunol.173.10.6357
  • Santosuosso M, McCormick S, Zhang X, Zganiacz A, Xing Z. Intranasal boosting with an adenovirus-vectored vaccine markedly enhances protection by parenteral Mycobacterium bovis BCG immunization against pulmonary tuberculosis. Infect Immun 2006; 74:4634-43; PMID:16861651; http://dx.doi.org/10.1128/IAI.00517-06
  • Santosuosso M, Zhang X, McCormick S, Wang J, Hitt M, Xing Z. Mechanisms of mucosal and parenteral tuberculosis vaccinations: adenoviral-based mucosal immunization preferentially elicits sustained accumulation of immune protective CD4 and CD8 T cells within the airway lumen. J Immunol 2005; 174:7986-94; PMID:15944305; http://dx.doi.org/10.4049/jimmunol.174.12.7986
  • Mu J, Jeyanathan M, Small CL, Zhang X, Roediger E, Feng X, Chong D, Gauldie J, Xing Z. Immunization with a bivalent adenovirus-vectored tuberculosis vaccine provides markedly improved protection over its monovalent counterpart against pulmonary tuberculosis. Mol Ther 2009; 17:1093-100; PMID:19319120; http://dx.doi.org/10.1038/mt.2009.60
  • Montagnani C, Chiappini E, Galli L, de Martino M. Vaccine against tuberculosis: what's new? BMC Infect Dis 2014; 14 Suppl 1:S2; PMID:24564340; http://dx.doi.org/10.1186/1471-2334-14-S1-S2
  • Olafsdottir TA, Lingnau K, Nagy E, Jonsdottir I. IC31, a two-component novel adjuvant mixed with a conjugate vaccine enhances protective immunity against pneumococcal disease in neonatal mice. Scand J Immunol 2009; 69:194-202; PMID:19281531; http://dx.doi.org/10.1111/j.1365-3083.2008.02225.x
  • van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, et al. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine 2011; 29:2100-9; PMID:21256189; http://dx.doi.org/10.1016/j.vaccine.2010.12.135
  • Reither K, Katsoulis L, Beattie T, Gardiner N, Lenz N, Said K, Mfinanga E, Pohl C, Fielding KL, Jeffery H, et al. Safety and immunogenicity of H1/IC31(R), an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial. PLoS One 2014; 9:e114602; PMID:25490675; http://dx.doi.org/10.1371/journal.pone.0114602
  • van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, et al. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine 2010; 28:3571-81; PMID:20226890; http://dx.doi.org/10.1016/j.vaccine.2010.02.094
  • Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin 2010; 6:1007-15; PMID:21178394; http://dx.doi.org/10.4161/hv.6.12.13143
  • Skeiky YA, Dietrich J, Lasco TM, Stagliano K, Dheenadhayalan V, Goetz MA, Cantarero L, Basaraba RJ, Bang P, Kromann I, et al. Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime-boost regimen. Vaccine 2010; 28:1084-93; PMID:19896449; http://dx.doi.org/10.1016/j.vaccine.2009.10.114
  • Billeskov R, Elvang TT, Andersen PL, Dietrich J. The HyVac4 subunit vaccine efficiently boosts BCG-primed anti-mycobacterial protective immunity. PLoS One 2012; 7:e39909; PMID:22768165; http://dx.doi.org/10.1371/journal.pone.0039909
  • Lin PL, Dietrich J, Tan E, Abalos RM, Burgos J, Bigbee C, Bigbee M, Milk L, Gideon HP, Rodgers M, et al. The multistage vaccine H56 boosts the effects of BCG to protect cynomolgus macaques against active tuberculosis and reactivation of latent Mycobacterium tuberculosis infection. J Clin Invest 2012; 122:303-14; PMID:22133873; http://dx.doi.org/10.1172/JCI46252
  • Skeiky YA, Lodes MJ, Guderian JA, Mohamath R, Bement T, Alderson MR, Reed SG. Cloning, expression, and immunological evaluation of two putative secreted serine protease antigens of Mycobacterium tuberculosis. Infect Immun 1999; 67:3998-4007; PMID:10417166
  • Leroux-Roels I, Forgus S, De Boever F, Clement F, Demoitie MA, Mettens P, Moris P, Ledent E, Leroux-Roels G, Ofori-Anyinam O, et al. 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 2013; 31:2196-206; PMID:22643213; http://dx.doi.org/10.1016/j.vaccine.2012.05.035
  • Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, Erasmus M, Makhethe L, Hughes EJ, Gelderbloem S, et al. Induction and regulation of T-cell immunity by the novel tuberculosis vaccine M72/AS01 in South African adults. Am J Respir Crit Care Med 2013; 188:492-502; PMID:23306546; http://dx.doi.org/10.1164/rccm.201208-1385OC
  • Penn-Nicholson A, Geldenhuys H, Burny W, van der Most R, Day CL, Jongert E, Moris P, Hatherill M, Ofori-Anyinam O, Hanekom W, et al. Safety and immunogenicity of candidate vaccine M72/AS01 in adolescents in a TB endemic setting. Vaccine 2015; PMID:26072017
  • Idoko OT, Owolabi OA, Owiafe PK, Moris P, Odutola A, Bollaerts A, Ogundare E, Jongert E, Demoitié MA, Ofori-Anyinam O, et al. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine when given as a booster to BCG in Gambian infants: an open-label randomized controlled trial. Tuberculosis (Edinb) 2014; 94:564-78; PMID:25305000
  • Bertholet S, Ireton GC, Ordway DJ, Windish HP, Pine SO, Kahn M, Phan T, Orme IM, Vedvick TS, Baldwin SL, et al. A defined tuberculosis vaccine candidate boosts BCG and protects against multidrug-resistant Mycobacterium tuberculosis. Sci Transl Med 2010; 2:53ra74; PMID:20944089; http://dx.doi.org/10.1126/scitranslmed.3001094
  • Baldwin SL, Bertholet S, Reese VA, Ching LK, Reed SG, Coler RN. The importance of adjuvant formulation in the development of a tuberculosis vaccine. J Immunol 2012; 188:2189-97; PMID:22291184; http://dx.doi.org/10.4049/jimmunol.1102696
  • Duthie MS, Coler RN, Laurance JD, Sampaio LH, Oliveira RM, Sousa AL, Stefani MM, Maeda Y, Matsuoka M, Makino M, et al. Protection against Mycobacterium leprae infection by the ID83/GLA-SE and ID93/GLA-SE vaccines developed for tuberculosis. Infect Immun 2014; 82:3979-85; PMID:25024362; http://dx.doi.org/10.1128/IAI.02145-14
  • Kagina BM, Abel B, Scriba TJ, Hughes EJ, Keyser A, Soares A, Gamieldien H, Sidibana M, Hatherill M, Gelderbloem S, et al. Specific T cell frequency and cytokine expression profile do not correlate with protection against tuberculosis after bacillus Calmette-Guerin vaccination of newborns. Am J Respir Crit Care Med 2010; 182:1073-9; PMID:20558627; http://dx.doi.org/10.1164/rccm.201003-0334OC
  • Dye C. Making wider use of the world's most widely used vaccine: Bacille Calmette-Guerin revaccination reconsidered. J R Soc Interface 2013; 10:20130365; PMID:23904584; http://dx.doi.org/10.1098/rsif.2013.0365
  • BCG vaccine. WHO position paper. Wkly Epidemiol Rec 2004; 79:27-38; PMID:14768305
  • Meeting of the immunization Strategic Advisory Group of Experts, April 2007–conclusions and recommendations. Wkly Epidemiol Rec 2007; 82:181-93; PMID:17526120
  • Tchakoute CT, Hesseling AC, Kidzeru EB, Gamieldien H, Passmore JA, Jones CE, Gray CM, Sodora DL, Jaspan HB. Delaying BCG vaccination until 8 weeks of age results in robust BCG-specific T-cell responses in HIV-exposed infants. J Infect Dis 2015; 211:338-46; PMID:25108027; http://dx.doi.org/10.1093/infdis/jiu434
  • Kay AW, Blish CA. Delayed BCG vaccination–time to take a shot. J Infect Dis 2015; 211:335-7; PMID:25108029; http://dx.doi.org/10.1093/infdis/jiu435
  • Blakney AK, Tchakoute CT, Hesseling AC, Kidzeru EB, Jones CE, Passmore JA, Sodora DL, Gray CM, Jaspan HB.. Delayed BCG vaccination results in minimal alterations in T cell immunogenicity of acellular pertussis and tetanus immunizations in HIV-exposed infants. Vaccine 2015; 33:4782-9; PMID:26259542; http://dx.doi.org/10.1016/j.vaccine.2015.07.096
  • Kagina BM, Abel B, Bowmaker M, Scriba TJ, Gelderbloem S, Smit E, Erasmus M, Nene N, Walzl G, Black G, et al. Delaying BCG vaccination from birth to 10 weeks of age may result in an enhanced memory CD4 T cell response. Vaccine 2009; 27:5488-95; PMID:19616494; http://dx.doi.org/10.1016/j.vaccine.2009.06.103
  • Burl S, Adetifa UJ, Cox M, Touray E, Ota MO, Marchant A, Whittle H, McShane H, Rowland-Jones SL, Flanagan KL. Delaying bacillus Calmette-Guerin vaccination from birth to 4 1/2 months of age reduces postvaccination Th1 and IL-17 responses but leads to comparable mycobacterial responses at 9 months of age. J Immunol 2010; 185:2620-8; PMID:20644160; http://dx.doi.org/10.4049/jimmunol.1000552
  • Tala-Heikkila MM, Tuominen JE, Tala EO. Bacillus Calmette-Guerin revaccination questionable with low tuberculosis incidence. Am J Respir Crit Care Med 1998; 157:1324-7; PMID:9563757; http://dx.doi.org/10.1164/ajrccm.157.4.9706037
  • Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Karonga Prevention Trial Group. Lancet 1996; 348:17-24; PMID:8691924; http://dx.doi.org/10.1016/S0140-6736(96)02166-6
  • Rodrigues LC, Pereira SM, Cunha SS, Genser B, Ichihara MY, de Brito SC, Hijjar MA, Dourado I, Cruz AA, Sant'Anna C, et al. Effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: the BCG-REVAC cluster-randomised trial. Lancet 2005; 366:1290-5; PMID:16214599; http://dx.doi.org/10.1016/S0140-6736(05)67145-0
  • World Health Organization. Guidance for national tuberculosis programmes on the management of tuberculosis in children. 2006; WHO/HTM/TB/2006.371.
  • Trial of BCG vaccines in south India for tuberculosis prevention: first report–Tuberculosis Prevention Trial. Bull World Health Organ 1979; 57:819-27; PMID:396057
  • Barreto ML, Pereira SM, Pilger D, Cruz AA, Cunha SS, Sant'Anna C, Ichihara MY, Genser B, Rodrigues LC. Evidence of an effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: second report of the BCG-REVAC cluster-randomised trial. Vaccine 2011; 29:4875-7; PMID:21616115; http://dx.doi.org/10.1016/j.vaccine.2011.05.023

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