Chapter 11 : BCG and New Vaccines for the Prevention of Tuberculosis

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this chapter:
Zoom in

BCG and New Vaccines for the Prevention of Tuberculosis, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555819866/9781555819859_Chap11-1.gif /docserver/preview/fulltext/10.1128/9781555819866/9781555819859_Chap11-2.gif


A critical component of global tuberculosis control is the development of more effective immunization strategies. Several tuberculosis vaccines have been shown to reduce the risk of disease and death due to tuberculosis in humans, but only one is used in global immunization programs: bacillus Calmette-Guérin (BCG). BCG is an attenuated live vaccine administered at birth to children in most countries where tuberculosis is endemic. BCG has been the most widely administered vaccine in the world, with an estimated three billion doses administered to date ( ). BCG has likely reduced the burden of tuberculosis in many areas, but it has numerous limitations. These limitations, together with the continuation of the global tuberculosis epidemic, have made the development of a more effective vaccine against tuberculosis a major international public health priority ( ).

Citation: Lahey T, von Reyn C. 2017. BCG and New Vaccines for the Prevention of Tuberculosis, p 187-209. In Schlossberg D (ed), Tuberculosis and Nontuberculous Mycobacterial Infections, Seventh Edition. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.TNMI7-0003-2016
Highlighted Text: Show | Hide
Loading full text...

Full text loading...


Image of Figure 1
Figure 1

Selected vaccines in advanced human clinical trials. P, clinical trial demonstrated protection from tuberculosis; F, clinical trial failed to show protection from tuberculosis. Based on references to , and .

Citation: Lahey T, von Reyn C. 2017. BCG and New Vaccines for the Prevention of Tuberculosis, p 187-209. In Schlossberg D (ed), Tuberculosis and Nontuberculous Mycobacterial Infections, Seventh Edition. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.TNMI7-0003-2016
Permissions and Reprints Request Permissions
Download as Powerpoint


1. Fine PE,, Carneiro IA,, Milstien JB,, Clements CJ . 1999. Issues relating to the use of bcg in immunization programs: a discussion document. Department of Vaccines and Biologicals, World Health Organization, Geneva, Switzerland. [PubMed]
2. Brennan MJ,, Fruth U . 2001. Global forum on TB vaccine research and development. World Health Organization, June 7–8, 2001. Tuberculosis (Edinburgh) 81 : 365 368.[PubMed] [CrossRef]
3. Andersen P . 2001. TB vaccines: progress and problems. Trends Immunol 22 : 160 168.
4. World Health Organization . 2015. Global Tuberculosis Report 2015. World Health Organization, Geneva, Switzerland.
5. Walls T,, Shingadia D . 2004. Global epidemiology of paediatric tuberculosis. J Infect 48 : 13 22.[PubMed] [CrossRef]
6. Romanus V,, Hallander HO,, Wåhlén P,, Olinder-Nielsen AM,, Magnusson PHW,, Juhlin I . 1995. Atypical mycobacteria in extrapulmonary disease among children. Incidence in Sweden from 1969 to 1990, related to changing BCG-vaccination coverage. Tuber Lung Dis 76 : 300 310.[CrossRef]
7. Horsburgh CR Jr . 2004. Priorities for the treatment of latent tuberculosis infection in the United States. N Engl J Med 350 : 2060 2067.[PubMed] [CrossRef]
8. Stead WW,, Lofgren JP,, Warren E,, Thomas C . 1985. Tuberculosis as an endemic and nosocomial infection among the elderly in nursing homes. N Engl J Med 312 : 1483 1487.[PubMed] [CrossRef]
9. Stead WW,, Dutt AK . 1989. Tuberculosis in the elderly. Semin Respir Infect 4 : 189 197.[PubMed]
10. Horsburgh CR Jr,, O’Donnell M,, Chamblee S,, Moreland JL,, Johnson J,, Marsh BJ,, Narita M,, Johnson LS,, von Reyn CF . 15 August 2010. Revisiting rates of reactivation tuberculosis: a population-based approach. Am J Respir Crit Care Med doi:10.1164/rccm.200909-1355OC. [PubMed] [CrossRef]
11. Murray CJ , , et al . 2014. Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 384 : 1005 1070.[PubMed] [CrossRef]
12. Harries AD,, Hargreaves NJ,, Kemp J,, Jindani A,, Enarson DA,, Maher D,, Salaniponi FM . 2001. Deaths from tuberculosis in sub-Saharan African countries with a high prevalence of HIV-1. Lancet 357 : 1519 1523.[PubMed] [CrossRef]
13. Lawn SD,, Bekker LG,, Miller RF . 2005. Immune reconstitution disease associated with mycobacterial infections in HIV-infected individuals receiving antiretrovirals. Lancet Infect Dis 5 : 361 373.[PubMed] [CrossRef]
14. Sonnenberg P,, Murray J,, Glynn JR,, Shearer S,, Kambashi B,, Godfrey-Faussett P . 2001. HIV-1 and recurrence, relapse, and reinfection of tuberculosis after cure: a cohort study in South African mineworkers. Lancet 358 : 1687 1693.[PubMed] [CrossRef]
15. Adams LV,, Kreiswirth BN,, Arbeit RD,, Soini H,, Mtei L,, Matee M,, Bakari M,, Lahey T,, Wieland-Alter W,, Shashkina E,, Kurepina N,, Driscoll JR,, Pallangyo K,, Horsburgh CR,, von Reyn CF . 2012. Molecular epidemiology of HIV-associated tuberculosis in Dar es Salaam, Tanzania: strain predominance, clustering, and polyclonal disease. J Clin Microbiol 50 : 2645 2650.[PubMed] [CrossRef]
16. Narayanan S,, Swaminathan S,, Supply P,, Shanmugam S,, Narendran G,, Hari L,, Ramachandran R,, Locht C,, Jawahar MS,, Narayanan PR . 2010. Impact of HIV infection on the recurrence of tuberculosis in South India. J Infect Dis 201 : 691 703.[PubMed] [CrossRef]
17. Flahiff EW . 1939. The occurrence of tuberculosis in persons who failed to react to tuberculin, and in persons with positive tuberculin reaction. Am J Epidemiol 30( Section B) : 69 74.
18. Zar HJ,, Cotton MF,, Strauss S,, Karpakis J,, Hussey G,, Schaaf HS,, Rabie H,, Lombard CJ . 2007. Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial. BMJ 334 : 136. [PubMed] [CrossRef]
19. Grant AD,, Charalambous S,, Fielding KL,, Day JH,, Corbett EL,, Chaisson RE,, De Cock KM,, Hayes RJ,, Churchyard GJ . 2005. Effect of routine isoniazid preventive therapy on tuberculosis incidence among HIV-infected men in South Africa: a novel randomized incremental recruitment study. JAMA 293 : 2719 2725.[PubMed] [CrossRef]
20. Johnson JL,, Okwera A,, Hom DL,, Mayanja H,, Mutuluuza Kityo C,, Nsubuga P,, Nakibali JG,, Loughlin AM,, Yun H,, Mugyenyi PN,, Vernon A,, Mugerwa RD,, Ellner JJ,, Whalen CC , Uganda-Case Western Reserve University Research Collaboration . 2001. Duration of efficacy of treatment of latent tuberculosis infection in HIV-infected adults. AIDS 15 : 2137 2147.[PubMed] [CrossRef]
21. Badri M,, Wilson D,, Wood R . 2002. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet 359 : 2059 2064.[PubMed] [CrossRef]
22. Golub JE,, Saraceni V,, Cavalcante SC,, Pacheco AG,, Moulton LH,, King BS,, Efron A,, Moore RD,, Chaisson RE,, Durovni B . 2007. The impact of antiretroviral therapy and isoniazid preventive therapy on tuberculosis incidence in HIV-infected patients in Rio de Janeiro, Brazil. AIDS 21 : 1441 1448.[PubMed] [CrossRef]
23. Jouanguy E,, Altare F,, Lamhamedi S,, Revy P,, Emile JF,, Newport M,, Levin M,, Blanche S,, Seboun E,, Fischer A,, Casanova JL,, Jouanguy E,, Altare F,, Lamhamedi S,, Revy P,, Emile JF,, Newport M,, Levin M,, Blanche S,, Seboun E,, Fischer A,, Casanova JL . 1996. Interferon-gamma-receptor deficiency in an infant with fatal bacille Calmette-Guérin infection. N Engl J Med 335 : 1956 1961.[PubMed] [CrossRef]
24. Mohan AK,, Coté TR,, Block JA,, Manadan AM,, Siegel JN,, Braun MM . 2004. Tuberculosis following the use of etanercept, a tumor necrosis factor inhibitor. Clin Infect Dis 39 : 295 299.[PubMed] [CrossRef]
25. Lopez de Castilla D,, Schluger NW . 9 December 2009. Tuberculosis following solid organ transplantation. Transpl Infect Dis doi:10.1111/j.1399-3062.2009.00475.x. [PubMed] [CrossRef]
26. Yuen KY,, Woo PC . 2002. Tuberculosis in blood and marrow transplant recipients. Hematol Oncol 20 : 51 62.[PubMed] [CrossRef]
27. McMurray DN . 1981. Cellular immune changes in undernourished children. Prog Clin Biol Res 67 : 305 318.[PubMed]
28. Chandra RNP . 1977. Nutrition, Immunity and Infection: Mechanisms of Interactions. Plenum Press, New York, NY. [CrossRef]
29. Hanrahan CF,, Golub JE,, Mohapi L,, Tshabangu N,, Modisenyane T,, Chaisson RE,, Gray GE,, McIntyre JA,, Martinson NA . BMI and risk of tuberculosis and death: a prospective cohort of HIV-infected adults from South Africa. AIDS doi:10.1097/QAD.0b013e32833a2a4a. [PubMed] [CrossRef]
30. Jeon CY,, Murray MB . 2008. Diabetes mellitus increases the risk of active tuberculosis: a systematic review of 13 observational studies. PLoS Med 5 : e152. [PubMed] [CrossRef]
31. Modi S,, Buff AM,, Lawson CJ,, Rodriguez D,, Kirking HL,, Lipman H,, Fishbein DB . 2009. Reporting patterns and characteristics of tuberculosis among international travelers, United States, June 2006 to May 2008. Clin Infect Dis 49 : 885 891.[PubMed] [CrossRef]
32. Leroy H,, Arvieux C,, Biziragusenyuka J,, Chapplain JM,, Guiguen C,, Michelet C,, Tattevin P . 2008. A retrospective study of 230 consecutive patients hospitalized for presumed travel-related illness (2000–2006). Eur J Clin Microbiol Infect Dis 27 : 1137 1140.[PubMed] [CrossRef]
33. Flahiff EW . 1939. The occurrence of tuberculosis in persons who failed to react to tuberculin, and in persons with positive tuberculin reactions. Am J Hyg 30 : 69 74.
34. Ziegler JE,, Edwards ML,, Smith DW . 1985. Exogenous reinfection in experimental airborne tuberculosis. Tubercle 66 : 121 128.[PubMed] [CrossRef]
35. Glynn JR,, Murray J,, Bester A,, Nelson G,, Shearer S,, Sonnenberg P . 2010. High rates of recurrence in HIV-infected and HIV-uninfected patients with tuberculosis. J Infect Dis 201 : 704 711.[PubMed] [CrossRef]
36. Lahey T,, Mackenzie T,, Arbeit RD,, Bakari M,, Mtei L,, Matee M,, Maro I,, Horsburgh CR,, Pallangyo K,, von Reyn CF . 2013. Recurrent tuberculosis risk among HIV-infected adults in Tanzania with prior active tuberculosis. Clin Infect Dis 56 : 151 158.[PubMed] [CrossRef]
37. Edwards LB,, Palmer CE . 1968. Biology of the mycobacterioses. Identification of the tuberculous-infected by skin tests. Ann N Y Acad Sci 154 : 140 148.[PubMed] [CrossRef]
38. Fine PEM . 1995. Variation in protection by BCG: implications of and for heterologous immunity. Lancet 346 : 1339 1345.[PubMed] [CrossRef]
39. Edwards ML,, Goodrich JM,, Muller D,, Pollack A,, Ziegler JE,, Smith DW . 1982. Infection with Mycobacterium avium-intracellulare and the protective effects of Bacille Calmette-Guérin. J Infect Dis 145 : 733 741.[PubMed] [CrossRef]
40. von Reyn CF,, Barber TW,, Arbeit RD,, Sox CH,, O’Connor GT,, Brindle RJ,, Gilks CF,, Hakkarainen K,, Ranki A,, Bartholomew C,, Tosteson ANA,, Magnusson M . 1993. Evidence of previous infection with M. avium among healthy subjects: an international study of dominant mycobacterial skin test reactions. J Infect Dis 168 : 1553 1558.[PubMed] [CrossRef]
41. Fairchok MP,, Rouse JH,, Morris SL . 1995. Age-dependent humoral responses of children to mycobacterial antigens. Clin Diagn Lab Immunol 2 : 443 447.[PubMed]
42. von Reyn CF,, Horsburgh CR,, Olivier KN,, Barnes PF,, Waddell R,, Warren C,, Tvaroha S,, Jaeger AS,, Lein AD,, Alexander LN,, Weber DJ,, Tosteson AN . 2001. Skin test reactions to Mycobacterium tuberculosis purified protein derivative and Mycobacterium avium sensitin among health care workers and medical students in the United States. Int J Tuberc Lung Dis 5 : 1122 1128.[PubMed]
43. Brandt L,, Feino Cunha J,, Weinreich Olsen A,, Chilima B,, Hirsch P,, Appelberg R,, Andersen P . 2002. Failure of the Mycobacterium bovis BCG vaccine: some species of environmental mycobacteria block multiplication of BCG and induction of protective immunity to tuberculosis. Infect Immun 70 : 672 678.[PubMed] [CrossRef]
44. Hart PD,, Sutherland I . 1977. BCG and vole bacillus vaccines in the prevention of tuberculosis in adolescence and early adult life. BMJ 2 : 293 295.[PubMed] [CrossRef]
45. Weiss DW . 1959. Vaccination against tuberculosis with nonliving vaccines. I. The problem and its historical background. Am Rev Respir Dis 80 : 676 688.[PubMed] [CrossRef]
46. Opie EL,, Flahiff EW,, Smith HH . 1939. Protective inoculation against human tuberculosis with heat-killed tubercle bacilli. Am J Hyg 29 : 155 164.
47. von Reyn CF,, Mtei L,, Arbeit RD,, Waddell R,, Cole B,, Mackenzie T,, Matee M,, Bakari M,, Tvaroha S,, Adams LV,, Horsburgh CR,, Pallangyo K , DarDar 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.[PubMed] [CrossRef]
48. Gutierrez MG,, Master SS,, Singh SB,, Taylor GA,, Colombo MI,, Deretic V . 2004. Autophagy is a defense mechanism inhibiting BCG and Mycobacterium tuberculosis survival in infected macrophages. Cell 119 : 753 766.[PubMed] [CrossRef]
49. Harris J,, De Haro SA,, Master SS,, Keane J,, Roberts EA,, Delgado M,, Deretic V . 2007. T helper 2 cytokines inhibit autophagic control of intracellular Mycobacterium tuberculosis . Immunity 27 : 505 517.[PubMed] [CrossRef]
50. Xu Y,, Jagannath C,, Liu XD,, Sharafkhaneh A,, Kolodziejska KE,, Eissa NT . 2007. Toll-like receptor 4 is a sensor for autophagy associated with innate immunity. Immunity 27 : 135 144.[PubMed] [CrossRef]
51. Thoma-Uszynski S,, Stenger S,, Takeuchi O,, Ochoa MT,, Engele M,, Sieling PA,, Barnes PF,, Rollinghoff M,, Bolcskei PL,, Wagner M,, Akira S,, Norgard MV,, Belisle JT,, Godowski PJ,, Bloom BR,, Modlin RL . 2001. Induction of direct antimicrobial activity through mammalian Toll-like receptors. Science 291 : 1544 1547.[PubMed] [CrossRef]
52. Liu PT,, Stenger S,, Li H,, Wenzel L,, Tan BH,, Krutzik SR,, Ochoa MT,, Schauber J,, Wu K,, Meinken C,, Kamen DL,, Wagner M,, Bals R,, Steinmeyer A,, Zügel U,, Gallo RL,, Eisenberg D,, Hewison M,, Hollis BW,, Adams JS,, Bloom BR,, Modlin RL . 2006. Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science 311 : 1770 1773.[PubMed] [CrossRef]
53. Mogues T,, Goodrich ME,, Ryan L,, LaCourse R,, North RJ . 2001. The relative importance of T cell subsets in immunity and immunopathology of airborne Mycobacterium tuberculosis infection in mice. J Exp Med 193 : 271 280.[PubMed] [CrossRef]
54. Wilkinson KA,, Seldon R,, Meintjes G,, Rangaka MX,, Hanekom WA,, Maartens G,, Wilkinson RJ . 2009. Dissection of regenerating T-cell responses against tuberculosis in HIV-infected adults sensitized by Mycobacterium tuberculosis . Am J Respir Crit Care Med 180 : 674 683.[PubMed] [CrossRef]
55. Day CL,, Mkhwanazi N,, Reddy S,, Mncube Z,, van der Stok M,, Klenerman P,, Walker BD . 2008. Detection of polyfunctional Mycobacterium tuberculosis-specific T cells and association with viral load in HIV-1-infected persons. J Infect Dis 197 : 990 999.[PubMed] [CrossRef]
56. Kursar M,, Koch M,, Mittrücker HW,, Nouailles G,, Bonhagen K,, Kamradt T,, Kaufmann SH . 2007. Cutting edge: regulatory T cells prevent efficient clearance of Mycobacterium tuberculosis . J Immunol 178 : 2661 2665.[PubMed] [CrossRef]
57. Khader SA,, Pearl JE,, Sakamoto K,, Gilmartin L,, Bell GK,, Jelley-Gibbs DM,, Ghilardi N,, deSauvage F,, Cooper AM . 2005. IL-23 compensates for the absence of IL-12p70 and is essential for the IL-17 response during tuberculosis but is dispensable for protection and antigen-specific IFN-gamma responses if IL-12p70 is available. J Immunol 175 : 788 795.[PubMed] [CrossRef]
58. Chen CY,, Huang D,, Wang RC,, Shen L,, Zeng G,, Yao S,, Shen Y,, Halliday L,, Fortman J,, McAllister M,, Estep J,, Hunt R,, Vasconcelos D,, Du G,, Porcelli SA,, Larsen MH,, Jacobs WR Jr,, Haynes BF,, Letvin NL,, Chen ZW . 2009. A critical role for CD8 T cells in a nonhuman primate model of tuberculosis. PLoS Pathog 5 : e1000392. [PubMed] [CrossRef]
59. Kagina BM,, Abel B,, Scriba TJ,, Hughes EJ,, Keyser A,, Soares A,, Gamieldien H,, Sidibana M,, Hatherill M,, Gelderbloem S,, Mahomed H,, Hawkridge A,, Hussey G,, Kaplan G,, Hanekom WA , other members of the South African Tuberculosis Vaccine Initiative . 2010. Specific T cell frequency and cytokine expression profile do not correlate with protection against tuberculosis after bacillus Calmette-Guérin vaccination of newborns. Am J Respir Crit Care Med 182 : 1073 1079.[PubMed] [CrossRef]
60. Abebe F,, Bjune G . 2009. The protective role of antibody responses during Mycobacterium tuberculosis infection. Clin Exp Immunol 157 : 235 243.[PubMed] [CrossRef]
61. Phuah J,, Wong EA,, Gideon HP,, Maiello P,, Coleman MT,, Hendricks MR,, Ruden R,, Cirrincione LR,, Chan J,, Lin PL,, Flynn JL . 2016. Effects of B cell depletion on early Mycobacterium tuberculosis infection in cynomolgus macaques. Infect Immun 84 : 1301 1311.[PubMed] [CrossRef]
62. Hart PD,, Armstrong JA,, Brown CA,, Draper P . 1972. Ultrastructural study of the behavior of macrophages toward parasitic mycobacteria. Infect Immun 5 : 803 807.[PubMed]
63. Kusner DJ . 2005. Mechanisms of mycobacterial persistence in tuberculosis. Clin Immunol 114 : 239 247.[PubMed] [CrossRef]
64. Boelaert JR,, Vandecasteele SJ,, Appelberg R,, Gordeuk VR . 2007. The effect of the host’s iron status on tuberculosis. J Infect Dis 195 : 1745 1753.[PubMed] [CrossRef]
65. McKinney JD,, Höner zu Bentrup K,, Muñoz-Elías EJ,, Miczak A,, Chen B,, Chan WT,, Swenson D,, Sacchettini JC,, Jacobs WR Jr,, Russell DG . 2000. Persistence of Mycobacterium tuberculosis in macrophages and mice requires the glyoxylate shunt enzyme isocitrate lyase. Nature 406 : 735 738.[PubMed] [CrossRef]
66. Manca C,, Tsenova L,, Bergtold A,, Freeman S,, Tovey M,, Musser JM,, Barry CE III,, Freedman VH,, Kaplan G . 2001. Virulence of a Mycobacterium tuberculosis clinical isolate in mice is determined by failure to induce Th1 type immunity and is associated with induction of IFN-alpha/beta. Proc Natl Acad Sci U S A 98 : 5752 5757.[PubMed] [CrossRef]
67. Ordway D,, Henao-Tamayo M,, Harton M,, Palanisamy G,, Troudt J,, Shanley C,, Basaraba RJ,, Orme IM . 2007. The hypervirulent Mycobacterium tuberculosis strain HN878 induces a potent TH1 response followed by rapid down-regulation. J Immunol 179 : 522 531.[PubMed] [CrossRef]
68. Dorhoi A,, Yeremeev V,, Nouailles G,, Weiner J III,, Jörg S,, Heinemann E,, Oberbeck-Müller D,, Knaul JK,, Vogelzang A,, Reece ST,, Hahnke K,, Mollenkopf HJ,, Brinkmann V,, Kaufmann SH . 2014. Type I IFN signaling triggers immunopathology in tuberculosis-susceptible mice by modulating lung phagocyte dynamics. Eur J Immunol 44 : 2380 2393.[PubMed] [CrossRef]
69. Wilkinson KA,, Walker NF,, Meintjes G,, Deffur A,, Nicol MP,, Skolimowska KH,, Matthews K,, Tadokera R,, Seldon R,, Maartens G,, Rangaka MX,, Besra GS,, Wilkinson RJ . 2015. Cytotoxic mediators in paradoxical HIV-tuberculosis immune reconstitution inflammatory syndrome. J Immunol 194 : 1748 1754.[PubMed] [CrossRef]
70. Elliott JH,, Vohith K,, Saramony S,, Savuth C,, Dara C,, Sarim C,, Huffam S,, Oelrichs R,, Sophea P,, Saphonn V,, Kaldor J,, Cooper DA,, Chhi Vun M,, French MA . 2009. Immunopathogenesis and diagnosis of tuberculosis and tuberculosis-associated immune reconstitution inflammatory syndrome during early antiretroviral therapy. J Infect Dis 200 : 1736 1745.[PubMed] [CrossRef]
71. Ravimohan S,, Tamuhla N,, Nfanyana K,, Steenhoff AP,, Letlhogile R,, Frank I,, MacGregor RR,, Gross R,, Weissman D,, Bisson GP . 2016. Robust reconstitution of tuberculosis-specific polyfunctional CD4+ T-cell responses and rising systemic interleukin 6 in paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome. Clin Infect Dis 62 : 795 803.[PubMed] [CrossRef]
72. Sakai S,, Kauffman KD,, Sallin MA,, Sharpe AH,, Young HA,, Ganusov VV,, Barber DL . 2016. CD4 T cell-derived IFN-γ plays a minimal role in control of pulmonary Mycobacterium tuberculosis infection and must be actively repressed by PD-1 to prevent lethal disease. PLoS Pathog 12 : e1005667. [PubMed] [CrossRef]
73. Olsen AW,, Williams A,, Okkels LM,, Hatch G,, Andersen P . 2004. Protective effect of a tuberculosis subunit vaccine based on a fusion of antigen 85B and ESAT-6 in the aerosol guinea pig model. Infect Immun 72 : 6148 6150.[PubMed] [CrossRef]
74. Lahey T,, Mitchell BK,, Arbeit RD,, Sheth S,, Matee M,, Horsburgh CR,, MacKenzie T,, Mtei L,, Bakari M,, Vuola JM,, Pallangyo K,, von Reyn CF . 2011. Polyantigenic interferon-γ responses are associated with protection from TB among HIV-infected adults with childhood BCG immunization. PLoS One 6 : e22074. [PubMed] [CrossRef]
75. Black GF,, Thiel BA,, Ota MO,, Parida SK,, Adegbola R,, Boom WH,, Dockrell HM,, Franken KL,, Friggen AH,, Hill PC,, Klein MR,, Lalor MK,, Mayanja H,, Schoolnik G,, Stanley K,, Weldingh K,, Kaufmann SH,, Walzl G,, Ottenhoff TH , GCGH Biomarkers for TB Consortium . 2009. Immunogenicity of novel DosR regulon-encoded candidate antigens of Mycobacterium tuberculosis in three high-burden populations in Africa. Clin Vaccine Immunol 16 : 1203 1212.[PubMed] [CrossRef]
76. Lewinsohn DM,, Briden AL,, Reed SG,, Grabstein KH,, Alderson MR . 2000. Mycobacterium tuberculosis-reactive CD8+ T lymphocytes: the relative contribution of classical versus nonclassical HLA restriction. J Immunol 165 : 925 930.[PubMed] [CrossRef]
77. Lewinsohn DA,, Winata E,, Swarbrick GM,, Tanner KE,, Cook MS,, Null MD,, Cansler ME,, Sette A,, Sidney J,, Lewinsohn DM . 2007. Immunodominant tuberculosis CD8 antigens preferentially restricted by HLA-B. PLoS Pathog 3 : 1240 1249.[PubMed] [CrossRef]
78. Joosten SA,, van Meijgaarden KE,, van Weeren PC,, Kazi F,, Geluk A,, Savage ND,, Drijfhout JW,, Flower DR,, Hanekom WA,, Klein MR,, Ottenhoff TH . 2010. Mycobacterium tuberculosis peptides presented by HLA-E molecules are targets for human CD8 T-cells with cytotoxic as well as regulatory activity. PLoS Pathog 6 : e1000782. [PubMed] [CrossRef]
79. Ulrichs T,, Moody DB,, Grant E,, Kaufmann SH,, Porcelli SA . 2003. T-cell responses to CD1-presented lipid antigens in humans with Mycobacterium tuberculosis infection. Infect Immun 71 : 3076 3087.[PubMed] [CrossRef]
80. Constant P,, Davodeau F,, Peyrat MA,, Poquet Y,, Puzo G,, Bonneville M,, Fournié JJ . 1994. Stimulation of human gamma delta T cells by nonpeptidic mycobacterial ligands. Science 264 : 267 270.[PubMed] [CrossRef]
81. Tanaka Y,, Morita CT,, Tanaka Y,, Nieves E,, Brenner MB,, Bloom BR . 1995. Natural and synthetic non-peptide antigens recognized by human gamma delta T cells. Nature 375 : 155 158.[PubMed] [CrossRef]
82. Sakula A . 1983. BCG: who were Calmette and Guérin? Thorax 38 : 806 812.[PubMed] [CrossRef]
83. Bendiner E . 1992. Albert Calmette: a vaccine and its vindication. Hosp Pract (Off Ed) 27( 10A) : 113 116, 119–122, 125 passim.[PubMed]
84. Behr MA . 2001. Correlation between BCG genomics and protective efficacy. Scand J Infect Dis 33 : 249 252.[PubMed] [CrossRef]
85. Aronson JD . 1948. Protective vaccination against tuberculosis with special reference to BCG vaccination. Am Rev Tuberc 58 : 255 281.[PubMed]
86. Trevenen CL,, Pagtakhan RD . 1982. Disseminated tuberculoid lesions in infants following BCG vaccination. Can Med Assoc J 127 : 502 504.[PubMed]
87. Surekha Rani H,, Vijaya Lakshmi V,, Sumanlatha G,, Murthy KJ . 2005. Cell-mediated immune responses in children towards secreted proteins of Mycobacterium bovis BCG. Tuberculosis (Edinburgh) 85 : 89 93.[PubMed] [CrossRef]
88. Lowry PW,, Ludwig TS,, Adams JA,, Fitzpatrick ML,, Grant SM,, Andrle GA,, Offerdahl MR,, Cho SN,, Jacobs DR Jr . 1998. Cellular immune responses to four doses of percutaneous bacille Calmette-Guérin in healthy adults. J Infect Dis 178 : 138 146.[PubMed] [CrossRef]
89. Kemp EB,, Belshe RB,, Hoft DF . 1996. Immune responses stimulated by percutaneous and intradermal bacille Calmette-Guérin. J Infect Dis 174 : 113 119.[PubMed] [CrossRef]
90. Ravn P,, Boesen H,, Pedersen BK,, Andersen P . 1997. Human T cell responses induced by vaccination with Mycobacterium bovis bacillus Calmette-Guérin. J Immunol 158 : 1949 1955.[PubMed]
91. Lowry PW,, Ludwig TS,, Adams JA,, Fitzpatrick ML,, Grant SM,, Andrle GA,, Offerdahl MR,, Cho SN,, Jacobs DR Jr . 1998. Cellular immune responses to four doses of percutaneous bacille Calmette-Guérin in healthy adults. J Infect Dis 178 : 138 146.[PubMed] [CrossRef]
92. Marchant A,, Goetghebuer T,, Ota MO,, Wolfe I,, Ceesay SJ,, De Groote D,, Corrah T,, Bennett S,, Wheeler J,, Huygen K,, Aaby P,, McAdam KP,, Newport MJ . 1999. Newborns develop a Th1-type immune response to Mycobacterium bovis bacillus Calmette-Guérin vaccination. J Immunol 163 : 2249 2255.[PubMed]
93. Lalor MK,, Smith SG,, Floyd S,, Gorak-Stolinska P,, Weir RE,, Blitz R,, Branson K,, Fine PE,, Dockrell HM . 2010. Complex cytokine profiles induced by BCG vaccination in UK infants. Vaccine 28 : 1635 1641.[PubMed] [CrossRef]
94. Soares AP,, Scriba TJ,, Joseph S,, Harbacheuski R,, Murray RA,, Gelderbloem SJ,, Hawkridge A,, Hussey GD,, Maecker H,, Kaplan G,, Hanekom WA . 2008. Bacillus Calmette-Guérin vaccination of human newborns induces T cells with complex cytokine and phenotypic profiles. J Immunol 180 : 3569 3577.[PubMed] [CrossRef]
95. Hoft DF,, Kemp EB,, Marinaro M,, Cruz O,, Kiyono H,, McGhee JR,, Belisle JT,, Milligan TW,, Miller JP,, Belshe RB . 1999. A double-blind, placebo-controlled study of Mycobacterium-specific human immune responses induced by intradermal bacille Calmette-Guérin vaccination. J Lab Clin Med 134 : 244 252.[PubMed] [CrossRef]
96. Beyazova U,, Rota S,, Cevheroğlu C,, Karsligil T . 1995. Humoral immune response in infants after BCG vaccination. Tuber Lung Dis 76 : 248 253.[PubMed] [CrossRef]
97. Rota S,, Beyazova U,, Karsligil T,, Cevheroğlu C . 1994. Humoral immune response against antigen 60 in BCG-vaccinated infants. Eur J Epidemiol 10 : 713 718.[PubMed] [CrossRef]
98. Turneer M,, Van Vooren JP,, Nyabenda J,, Legros F,, Lecomte A,, Thiriaux J,, Serruys E,, Yernault JC . 1988. The humoral immune response after BCG vaccination in humans: consequences for the serodiagnosis of tuberculosis. Eur Respir J 1 : 589 593.[PubMed]
99. Hawkridge A,, Hatherill M,, Little F,, Goetz MA,, Barker L,, Mahomed H,, Sadoff J,, Hanekom W,, Geiter L,, Hussey G , South African BCG trial team . 2008. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ 337 : a2052. [PubMed] [CrossRef]
100. Mansoor N,, Scriba TJ,, de Kock M,, Tameris M,, Abel B,, Keyser A,, Little F,, Soares A,, Gelderbloem S,, Mlenjeni S,, Denation L,, Hawkridge A,, Boom WH,, Kaplan G,, Hussey GD,, Hanekom WA . 2009. HIV-1 infection in infants severely impairs the immune response induced by Bacille Calmette-Guérin vaccine. J Infect Dis 199 : 982 990.[PubMed] [CrossRef]
101. Minhinnick A,, Harris S,, Wilkie M,, Peter J,, Stockdale L,, Manjaly-Thomas ZR,, Vermaak S,, Satti I,, Moss P,, McShane H . 2016. Optimization of a human Bacille Calmette-Guérin challenge model: a tool to evaluate antimycobacterial immunity. J Infect Dis 213 : 824 830.[PubMed] [CrossRef]
102. Kaufmann SH,, Fortune S,, Pepponi I,, Ruhwald M,, Schrager LK,, Ottenhoff TH . 2016. TB biomarkers, TB correlates and human challenge models: new tools for improving assessment of new TB vaccines. Tuberculosis (Edinburgh) 99( Suppl 1) : S8 S11.[PubMed] [CrossRef]
103. Sharpe SA,, McShane H,, Dennis MJ,, Basaraba RJ,, Gleeson F,, Hall G,, McIntyre A,, Gooch K,, Clark S,, Beveridge NE,, Nuth E,, White A,, Marriott A,, Dowall S,, Hill AV,, Williams A,, Marsh PD . 2010. Establishment of an aerosol challenge model of tuberculosis in rhesus macaques and an evaluation of endpoints for vaccine testing. Clin Vaccine Immunol 17 : 1170 1182.[PubMed] [CrossRef]
104. Minassian AM,, Satti I,, Poulton ID,, Meyer J,, Hill AV,, McShane H . 2012. A human challenge model for Mycobacterium tuberculosis using Mycobacterium bovis bacille Calmette-Guerin. J Infect Dis 205 : 1035 1042.[PubMed] [CrossRef]
105. von Reyn CF,, Williams PL,, Lederman HM,, McCutchan JA,, Koletar SL,, Murphy RL,, Cohn SE,, Evans T,, Heald AE,, Colquhoun D,, Bassily EL,, Currier JS . 2001. Skin test reactivity and cellular immune responses to Mycobacterium avium sensitin in AIDS patients at risk for disseminated M. avium infection. Clin Diagn Lab Immunol 8 : 1277 1278.[PubMed] [CrossRef]
106. Vuola J,, Cole B,, Matee M,, Mtei L,, Horsburgh CR,, Arbeit RD,, Pallangyo KJ,, von Reyn CF . Baseline mycobacterial immunity in HIV-positive adults entering the DARDAR TB booster vaccine trial in Tanzania [abstract 882], 42nd Annual Meeting of the Infectious Disease Society of America; September 30-October 3, 2004.
107. Matee M,, Lahey T,, Vuola JM,, Mtei L,, Cole BF,, Bakari M,, Arbeit RD,, Horsburgh CR,, Pallangyo K,, von Reyn CF . 2007. Baseline mycobacterial immune responses in HIV-infected adults primed with bacille Calmette-Guérin during childhood and entering a tuberculosis booster vaccine trial. J Infect Dis 195 : 118 123.[PubMed] [CrossRef]
108. Barreto ML,, Cunha SS,, Pereira SM,, Genser B,, Hijjar MA,, Yury Ichihara M,, de Brito SC,, Dourado I,, Cruz A,, Santa’Ana C,, Rodrigues LC . 2005. Neonatal BCG protection against tuberculosis lasts for 20 years in Brazil. Int J Tuberc Lung Dis 9 : 1171 1173.[PubMed]
109. Ferguson RG,, Simes AB . 1949. BCG vaccination of Indian infants in Saskatchewan. Tubercle 30 : 5 11.[PubMed] [CrossRef]
110. Rosenthal SR,, Loewinsohn E,, Graham ML,, Liveright D,, Thorne MG,, Johnson V . 1961. BCG vaccination in tuberculous households. Am Rev Respir Dis 84 : 690 704.[PubMed]
111. Rosenthal SR,, Loewinsohne,, Graham ML,, Liveright D,, Thorne G,, Johnson V,, Batson HC . 1961. BCG vaccination against tuberculosis in Chicago. A twenty-year study statistically analyzed. Pediatrics 28 : 622 641.[PubMed]
112. Levine MI,, Sackett MF . 1946. Results of BCG immunization in New York City. Am Rev Tuberc 53 : 517 532.[PubMed]
113. Rodrigues LC,, Diwan VK,, Wheeler JG . 1993. Protective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. Int J Epidemiol 22 : 1154 1158.[PubMed] [CrossRef]
114. Aronson NE,, Santosham M,, Comstock GW,, Howard RS,, Moulton LH,, Rhoades ER,, Harrison LH . 2004. Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: a 60-year follow-up study. JAMA 291 : 2086 2091.[PubMed] [CrossRef]
115. Tuberculosis MTP . 1980. Trial of BCG vaccines in South India for tuberculosis prevention. Indian J Med Res 72( Suppl) : 174.
116. Tripathy SP . 1986. Fifteen year follow-up of the Indian BCG prevention trial, p 69 72. In International Union Against Tuberculosis. Professional Postgraduate Services KK, Singapore.
117. Narayanan PR . 2006. Influence of sex, age & nontuberculous infection at intake on the efficacy of BCG: re-analysis of 15-year data from a double-blind randomized control trial in South India. Indian J Med Res 123 : 119 124.[PubMed]
118. Marsh BJ,, von Reyn CF,, Edwards J,, Ristola MA,, Bartholomew C,, Brindle RJ,, Gilks CF,, Waddell R,, Tosteson AN,, Pelz R,, Sox CH,, Frothingham R,, Arbeit RD , International MAC Study Group . 1997. The risks and benefits of childhood bacille Calmette-Guérin immunization among adults with AIDS. AIDS 11 : 669 672.[PubMed] [CrossRef]
119. Waddell RD,, Lishimpi K,, von Reyn CF,, Chintu C,, Baboo KS,, Kreiswirth B,, Talbot EA,, Karagas MR , Group DUUCS, Dartmouth/UCLMS/UNZA Collaborative Study Group . 2001. Bacteremia due to Mycobacterium tuberculosis or M. bovis, Bacille Calmette-Guérin (BCG) among HIV-positive children and adults in Zambia. AIDS 15 : 55 60.[PubMed] [CrossRef]
120. Talbot EA,, Perkins MD,, Silva SF,, Frothingham R . 1997. Disseminated bacille Calmette-Guérin disease after vaccination: case report and review. Clin Infect Dis 24 : 1139 1146.[PubMed] [CrossRef]
121. Hesseling AC,, Schaaf HS,, Hanekom WA,, Beyers N,, Cotton MF,, Gie RP,, Marais BJ,, van Helden P,, Warren RM . 2003. Danish bacille Calmette-Guérin vaccine-induced disease in human immunodeficiency virus-infected children. Clin Infect Dis 37 : 1226 1233.[PubMed] [CrossRef]
122. Hesseling AC,, Marais BJ,, Gie RP,, Schaaf HS,, Fine PE,, Godfrey-Faussett P,, Beyers N . 2007. The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children. Vaccine 25 : 14 18.[PubMed] [CrossRef]
123. Clemens JD,, Chuong JJ,, Feinstein AR . 1983. The BCG controversy. A methodological and statistical reappraisal. JAMA 249 : 2362 2369.[PubMed] [CrossRef]
124. Colditz GA,, Berkey CS,, Mosteller F,, Brewer TF,, Wilson ME,, Burdick E,, Fineberg HV . 1995. The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature. Pediatrics 96 : 29 35.[PubMed]
125. Colditz GA,, Brewer TF,, Berkey CS,, Wilson ME,, Burdick E,, Fineberg HV,, Mosteller F . 1994. Efficacy of BCG vaccine in the prevention of tuberculosis. Meta-analysis of the published literature. JAMA 271 : 698 702.[PubMed] [CrossRef]
126. Vandiviere HM,, Dworski M,, Melvin IG,, Watson KA,, Begley J . 1973. Efficacy of bacillus Calmette-Guérin and isoniazid-resistant bacillus Calmette-Guérin with and without isoniazid chemoprophylaxis from day of vaccination. II. Field trial in man. Am Rev Respir Dis 108 : 301 313.[PubMed]
127. von Reyn CF,, Mtei L,, Arbeit RD,, Waddell R,, Cole B,, Mackenzie T,, Matee M,, Bakari M,, Tvaroha S,, Adams LV,, Horsburgh CR,, Pallangyo K , DarDar 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.[PubMed] [CrossRef]
128. Roy A,, Eisenhut M,, Harris RJ,, Rodrigues LC,, Sridhar S,, Habermann S,, Snell L,, Mangtani P,, Adetifa I,, Lalvani A,, Abubakar I . 2014. Effect of BCG vaccination against Mycobacterium tuberculosis infection in children: systematic review and meta-analysis. BMJ 349 : g4643. [PubMed] [CrossRef]
129. Soysal A,, Millington KA,, Bakir M,, Dosanjh D,, Aslan Y,, Deeks JJ,, Efe S,, Staveley I,, Ewer K,, Lalvani A . 2005. Effect of BCG vaccination on risk of Mycobacterium tuberculosis infection in children with household tuberculosis contact: a prospective community-based study. Lancet 366 : 1443 1451.[PubMed] [CrossRef]
130. Eisenhut M,, Paranjothy S,, Abubakar I,, Bracebridge S,, Lilley M,, Mulla R,, Lack K,, Chalkley D,, McEvoy M . 2009. BCG vaccination reduces risk of infection with Mycobacterium tuberculosis as detected by gamma interferon release assay. Vaccine 27 : 6116 6120.[PubMed] [CrossRef]
131. Hawn TR,, Day TA,, Scriba TJ,, Hatherill M,, Hanekom WA,, Evans TG,, Churchyard GJ,, Kublin JG,, Bekker LG,, Self SG . 2014. Tuberculosis vaccines and prevention of infection. Microbiol Mol Biol Rev 78 : 650 671.[PubMed] [CrossRef]
132. Abubakar I,, Pimpin L,, Ariti C,, Beynon R,, Mangtani P,, Sterne JA,, Fine PE,, Smith PG,, Lipman M,, Elliman D,, Watson JM,, Drumright LN,, Whiting PF,, Vynnycky E,, Rodrigues LC . 2013. Systematic review and meta-analysis of the current evidence on the duration of protection by bacillus Calmette-Guérin vaccination against tuberculosis. Health Technol Assess 17 : 1 372, v–vi.[PubMed] [CrossRef]
133. Colditz GA,, Berkey CS,, Mosteller F,, Brewer TF,, Wilson ME,, Burdick E,, Fineberg HV . 1995. The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis: meta-analyses of the published literature. Pediatrics 96 : 29 35.[PubMed]
134. Nguipdop-Djomo P,, Heldal E,, Rodrigues LC,, Abubakar I,, Mangtani P . 2016. Duration of BCG protection against tuberculosis and change in effectiveness with time since vaccination in Norway: a retrospective population-based cohort study. Lancet Infect Dis 16 : 219 226.[PubMed] [CrossRef]
135. Rodrigues LC,, Pereira SM,, Cunha SS,, Genser B,, Ichihara MY,, de Brito SC,, Hijjar MA,, Dourado I,, Cruz AA,, Sant’Anna C,, Bierrenbach AL,, Barreto ML . 2005. Effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: the BCG-REVAC cluster-randomised trial. Lancet 366 : 1290 1295.[PubMed] [CrossRef]
136. Leung CC,, Tam CM,, Chan SL,, Chan-Yeung M,, Chan CK,, Chang KC . 2001. Efficacy of the BCG revaccination programme in a cohort given BCG vaccination at birth in Hong Kong. Int J Tuberc Lung Dis 5 : 717 723.[PubMed]
137. Cunha SS,, Alexander N,, Barreto ML,, Pereira ES,, Dourado I,, Maroja MF,, Ichihara Y,, Brito S,, Pereira S,, Rodrigues LC . 2008. BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial. PLoS Negl Trop Dis 2 : e167. [PubMed] [CrossRef]
138. Karonga Prevention Trial Group . 1996. Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Lancet 348 : 1724.[PubMed] [CrossRef]
139. Barbosa T,, Arruda S,, Fernandes BD,, Carvalho LP,, Cardoso S,, Cunha S,, Barreto ML,, Pereira SM,, Rodrigues LC,, Barral-Netto M . 2003. BCG (Bacille of Calmette-Guérin) revaccination leads to improved in vitro IFN-gamma response to mycobacterial antigen independent of tuberculin sensitization in Brazilian school-age children. Vaccine 21 : 2152 2160.[PubMed] [CrossRef]
140. Smith PG,, Revill WD,, Lukwago E,, Rykushin YP . 1976. The protective effect of BCG against Mycobacterium ulcerans disease: a controlled trial in an endemic area of Uganda. Trans R Soc Trop Med Hyg 70 : 449 457.[CrossRef]
141. Portaels F,, Aguiar J,, Debacker M,, Guédénon A,, Steunou C,, Zinsou C,, Meyers WM . 2004. Mycobacterium bovis BCG vaccination as prophylaxis against Mycobacterium ulcerans osteomyelitis in Buruli ulcer disease. Infect Immun 72 : 62 65.[PubMed] [CrossRef]
142. Phillips RO,, Phanzu DM,, Beissner M,, Badziklou K,, Luzolo EK,, Sarfo FS,, Halatoko WA,, Amoako Y,, Frimpong M,, Kabiru AM,, Piten E,, Maman I,, Bidjada B,, Koba A,, Awoussi KS,, Kobara B,, Nitschke J,, Wiedemann FX,, Kere AB,, Adjei O,, Löscher T,, Fleischer B,, Bretzel G,, Herbinger KH . 2015. Effectiveness of routine BCG vaccination on buruli ulcer disease: a case-control study in the Democratic Republic of Congo, Ghana and Togo. PLoS Negl Trop Dis 9 : e3457. [PubMed] [CrossRef]
143. Katila ML,, Brander E,, Backman A . 1987. Neonatal BCG vaccination and mycobacterial cervical adenitis in childhood. Tubercle 68 : 291 296.[PubMed] [CrossRef]
144. Roth A,, Jensen H,, Garly ML,, Djana Q,, Martins CL,, Sodemann M,, Rodrigues A,, Aaby P . 2004. Low birth weight infants and Calmette-Guérin bacillus vaccination at birth: community study from Guinea-Bissau. Pediatr Infect Dis J 23 : 544 550.[PubMed] [CrossRef]
145. Kristensen I,, Aaby P,, Jensen H,, Fine P . 2000. Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa. BMJ 321 : 1435 1438.[PubMed] [CrossRef]
146. Smith KC,, Starke JR, . 1999. Bacille Calmette Guerin vaccine, p 121. In Plotkin SA,, Orenstein WA (ed), Vaccines. WB Saunders, Philadelphia, PA.
147. Lotte A,, Wasz-Höckert O,, Poisson N,, Dumitrescu N,, Verron M,, Couvet E . 1984. BCG complications. Estimates of the risks among vaccinated subjects and statistical analysis of their main characteristics. Adv Tuberc Res 21 : 107 193.[PubMed]
148. Praveen KN,, Smikle MF,, Prabhakar P,, Pande D,, Johnson B,, Ashley D . 1990. Outbreak of Bacillus Calmette-Guérin-associated lymphadenitis and abscesses in Jamaican children. Pediatr Infect Dis J 9 : 890 893.[PubMed] [CrossRef]
149. Brewer MA,, Edwards KM,, Palmer PS,, Hinson HP . 1994. Bacille Calmette-Guérin immunization in normal healthy adults. J Infect Dis 170 : 476 479.[PubMed] [CrossRef]
150. Turnbull FM,, McIntyre PB,, Achat HM,, Wang H,, Stapledon R,, Gold M,, Burgess MA . 2002. National study of adverse reactions after vaccination with bacille Calmette-Guérin. Clin Infect Dis 34 : 447 453.[PubMed] [CrossRef]
151. Kröger L,, Korppi M,, Brander E,, Kröger H,, Wasz-Höckert O,, Backman A,, Rapola J,, Launiala K,, Katila ML . 1995. Osteitis caused by bacille Calmette-Guérin vaccination: a retrospective analysis of 222 cases. J Infect Dis 172 : 574 576.[PubMed] [CrossRef]
152. Caglayan S,, Yegin O,, Kayran K,, Timocin N,, Kasirga E,, Gun M . 1987. Is medical therapy effective for regional lymphadenitis following BCG vaccination? Am J Dis Child 141 : 1213 1214.[PubMed] [CrossRef]
153. Goraya JS,, Virdi VS . 2001. Treatment of Calmette-Guérin bacillus adenitis: a metaanalysis. Pediatr Infect Dis J 20 : 632 634.[PubMed] [CrossRef]
154. Hesseling AC,, Cotton MF,, Fordham von Reyn C,, Graham SM,, Gie RP,, Hussey GD . 2008. Consensus statement on the revised World Health Organization recommendations for BCG vaccination in HIV-infected infants. Int J Tuberc Lung Dis 12 : 1376 1379.[PubMed]
155. Azzopardi P,, Bennett CM,, Graham SM,, Duke T . 2009. Bacille Calmette-Guérin vaccine-related disease in HIV-infected children: a systematic review. Int J Tuberc Lung Dis 13 : 1331 1344.[PubMed]
156. Talbot EA,, Perkins MD,, Silva SFM,, Frothingham R . 1997. Disseminated bacille Calmette-Guérin disease after vaccination: case report and review. Clin Infect Dis 24 : 1139 1146.[PubMed] [CrossRef]
157. Tala E,, Romanus V,, Tala-Heikkilä M . 1997. Bacille Calmette-Guérin vaccination in the 21st century. Eur Respir Mon 4 : 327 353.
158. Romanus V,, Svensson A,, Hallander HO . 1992. The impact of changing BCG coverage on tuberculosis incidence in Swedish-born children between 1969 and 1989. Tuber Lung Dis 73 : 150 161.[PubMed] [CrossRef]
159. Salo EP . 2006. BCG in Finland: changing from a universal to a selected programme. Euro Surveill 11 : 18 20.[PubMed]
160. Hersh AL,, Tala-Heikkilä M,, Tala E,, Tosteson ANA,, Fordham von Reyn C . 2003. A cost-effectiveness analysis of universal versus selective immunization with Mycobacterium bovis bacille Calmette-Guérin in Finland. Int J Tuberc Lung Dis 7 : 22 29.[PubMed]
161. Abruzzi WA Jr,, Hummel RJ . 1953. Tuberculosis: incidence among American medical students, prevention and control and the use of BCG. N Engl J Med 248 : 722 729.[PubMed] [CrossRef]
162. Brewer TF,, Heymann SJ,, Krumplitsch SM,, Wilson ME,, Colditz GA,, Fineberg HV . 2001. Strategies to decrease tuberculosis in us homeless populations: a computer simulation model. JAMA 286 : 834 842.[PubMed] [CrossRef]
163. Cobelens FG,, van Deutekom H,, Draayer-Jansen IW,, Schepp-Beelen AC,, van Gerven PJ,, van Kessel RP,, Mensen ME . 2000. Risk of infection with Mycobacterium tuberculosis in travellers to areas of high tuberculosis endemicity. Lancet 356 : 461 465.[PubMed] [CrossRef]
164. World Health Organization . 2016. Call for nomination for experts to serve on a SAGE working group on the use of bacille Calmette-Guérin (BCG) vaccine. World Health Organization, Geneva, Switzerland. http://www.who.int/immunization/policy/sage/working_group_bcg/en/.
165. Hatherill M,, Scriba TJ,, Udwadia ZF,, Mullerpattan JB,, Hawkridge A,, Mahomed H,, Dye C . 2016. BCG and new preventive tuberculosis vaccines: implications for healthcare workers. Clin Infect Dis 62( Suppl 3) : S262 S267.[PubMed] [CrossRef]
166. Shelley MD,, Wilt TJ,, Court J,, Coles B,, Kynaston H,, Mason MD . 2004. Intravesical bacillus Calmette-Guérin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int 93 : 485 490.[PubMed] [CrossRef]
167. Knight GM,, Griffiths UK,, Sumner T,, Laurence YV,, Gheorghe A,, Vassall A,, Glaziou P,, White RG . 2014. Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries. Proc Natl Acad Sci U S A 111 : 15520 15525.[PubMed] [CrossRef]
168. von Reyn CF,, Vuola JM . 2002. New vaccines for the prevention of tuberculosis. Clin Infect Dis 35 : 465 474.[PubMed] [CrossRef]
169. Hoft DF,, Brown RM,, Belshe RB . 2000. Mucosal bacille calmette-Guérin vaccination of humans inhibits delayed-type hypersensitivity to purified protein derivative but induces mycobacteria-specific interferon-gamma responses. Clin Infect Dis 30( Suppl 3) : S217 S222.[PubMed] [CrossRef]
170. Orme IM,, McMurray DN,, Belisle JT . 2001. Tuberculosis vaccine development: recent progress. Trends Microbiol 9 : 115 118.[PubMed] [CrossRef]
171. Morais Fonseca D,, Rosada RS,, e Paula MO,, Wowk PF,, Franco LH,, Soares EG,, Silva CL,, Deperon Bonato VL . 2010. Experimental tuberculosis: designing a better model to test vaccines against tuberculosis. Tuberculosis (Edinburgh) 90 : 135 142.[PubMed] [CrossRef]
172. Langermans JA,, Andersen P,, van Soolingen D,, Vervenne RA,, Frost PA,, van der Laan T,, van Pinxteren LA,, van den Hombergh J,, Kroon S,, Peekel I,, Florquin S,, Thomas AW . 2001. Divergent effect of bacillus Calmette-Guérin (BCG) vaccination on Mycobacterium tuberculosis infection in highly related macaque species: implications for primate models in tuberculosis vaccine research. Proc Natl Acad Sci U S A 98 : 11497 11502.[PubMed] [CrossRef]
173. Kupz A,, Zedler U,, Stäber M,, Kaufmann SH . 2016. A mouse model of latent tuberculosis infection to study intervention strategies to prevent reactivation. PLoS One 11 : e0158849. [PubMed] [CrossRef]
174. Calderon VE,, Valbuena G,, Goez Y,, Judy BM,, Huante MB,, Sutjita P,, Johnston RK,, Estes DM,, Hunter RL,, Actor JK,, Cirillo JD,, Endsley JJ . 2013. A humanized mouse model of tuberculosis. PLoS One 8 : e63331. [PubMed] [CrossRef]
175. Lalvani A,, Sridhar S,, von Reyn CF . 2013. Tuberculosis vaccines: time to reset the paradigm? Thorax 68 : 1092 1094.[PubMed] [CrossRef]
176. Horsburgh CR Jr . 2000. A large, simple trial of a tuberculosis vaccine. Clin Infect Dis 30( Suppl 3) : S213 S216.[PubMed] [CrossRef]
177. von Reyn CF . 1999. The significance of bacteremic tuberculosis among persons with HIV infection in developing countries. AIDS 13 : 2193 2195.[PubMed] [CrossRef]
178. Bhatt DL,, Mehta C . 2016. Adaptive designs for clinical trials. N Engl J Med 375 : 65 74.[PubMed] [CrossRef]
179. Montgomery CM . 2016. Adaptive trials for tuberculosis: early reflections on theory and practice. Int J Tuberc Lung Dis 20 : 1091 1098.[PubMed] [CrossRef]
180. Lambert PH,, Hawkridge T,, Hanekom WA . 2009. New vaccines against tuberculosis. Clin Chest Med 30 : 811 826, x.[PubMed] [CrossRef]