Tuberculosis vaccines in clinical trials

References

• Daniel TM. The history of tuberculosis. Respir. Med.100(11), 1862–1870 (2006).
   PubMed Web of Science ®Google Scholar
• WHO. BCG vaccine. WHO position paper. Wkly Epidemiol. Rec.79(4), 27–38 (2004).
   PubMedGoogle Scholar
• Onozaki I, Raviglione M. Stopping tuberculosis in the 21st Century: goals and strategies. Respirology15(1), 32–43 (2010).
   PubMedGoogle Scholar
• Saltini C. Chemotherapy and diagnosis of tuberculosis. Respir. Med.100(12), 2085–2097 (2006).
   PubMedGoogle Scholar
• Dye C, Williams BG. The population dynamics and control of tuberculosis. Science328(5980), 856–861 (2010).
   PubMed Web of Science ®Google Scholar
• WHO STP. The Global Plan to Stop TB 2011–2015. WHO, Geneva, Switzerland (2010).
   Google Scholar
• WHO. Global Tuberculosis Control. WHO, Geneva, Switzerland (2009).
   Google Scholar
• Abu-Raddad LJ, Sabatelli L, Achterberg JT et al. Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics. Proc. Natl Acad. Sci. USA106(33), 13980–13985 (2009).
   PubMed Web of Science ®Google Scholar
• Hesseling AC, Marais BJ, Gie RP et al. The risk of disseminated Bacille Calmette–Guérin (BCG) disease in HIV-infected children. Vaccine25(1), 14–18 (2007).
   PubMed Web of Science ®Google Scholar
• Revised BCG vaccination guidelines for infants at risk for HIV infection. Wkly Epidemiol. Rec.82(21), 193–196 (2007).
   PubMedGoogle Scholar
• Fine PE. BCG vaccination against tuberculosis and leprosy. Br. Med. Bull.44(3), 691–703 (1988).
   PubMed Web of Science ®Google Scholar
• 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. Lancet366(9493), 1290–1295 (2005).
   PubMed Web of Science ®Google Scholar
• Colditz GA, Brewer TF, Berkey CS et al. Efficacy of BCG vaccine in the prevention of tuberculosis. Meta-analysis of the published literature. JAMA271(9), 698–702 (1994).
   PubMed Web of Science ®Google Scholar
• Sterne JA, Rodrigues LC, Guedes IN. Does the efficacy of BCG decline with time since vaccination? Int. J. Tuberc. Lung Dis.2(3), 200–207 (1998).
   PubMed Web of Science ®Google Scholar
• Aronson NE, Santosham M, Comstock GW et al. Long-term efficacy of BCG vaccine in American Indians and Alaska natives: a 60-year follow-up study. JAMA291(17), 2086–2091 (2004).
   PubMed Web of Science ®Google Scholar
• Behr MA. BCG – different strains, different vaccines? Lancet Infect. Dis.2(2), 86–92 (2002).
   PubMed Web of Science ®Google Scholar
• Ritz N, Hanekom WA, Robins-Browne R, Britton WJ, Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol. Rev.32(5), 821–841 (2008).
   PubMed Web of Science ®Google Scholar
• Fine PE. Variation in protection by BCG: implications of and for heterologous immunity. Lancet346(8986), 1339–1345 (1995).
   PubMed Web of Science ®Google Scholar
• Black GF, Dockrell HM, Crampin AC et al. Patterns and implications of naturally acquired immune responses to environmental and tuberculous mycobacterial antigens in northern Malawi. J. Infect. Dis.184(3), 322–329 (2001).
   PubMed Web of Science ®Google Scholar
• Brandt L, Feino Cunha J, Weinreich Olsen A et al. 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(2), 672–678 (2002).
   PubMed Web of Science ®Google Scholar
• Black GF, Fine PEM, Warndorff DK et al. Relationship between IFN-γ and skin test responsiveness to Mycobacterium tuberculosis PPD in healthy, non-BCG-vaccinated young adults in Northern Malawi. Int. J. Tuberc. Lung Dis5(7), 664–672 (2001).
   PubMed Web of Science ®Google Scholar
• Black GF, Weir RE, Floyd S et al. BCG-induced increase in interferon-γ response to mycobacterial antigens and efficacy of BCG vaccination in Malawi and the UK: two randomised controlled studies. Lancet359(9315), 1393–1401 (2002).
   PubMed Web of Science ®Google Scholar
• Lalor MK, Ben-Smith A, Gorak-Stolinska P et al. Population differences in immune responses to bacille Calmette–Guérin vaccination in infancy. J. Infect. Dis.199(6), 795–800 (2009).
   PubMed Web of Science ®Google Scholar
• Elias D, Britton S, Aseffa A, Engers H, Akuffo H. Poor immunogenicity of BCG in helminth infected population is associated with increased in vitro TGF-β production. Vaccine26(31), 3897–3902 (2008).
   PubMed Web of Science ®Google Scholar
• Orme IM. Preclinical testing of new vaccines for tuberculosis: a comprehensive review. Vaccine24(1), 2–19 (2006).
   PubMed Web of Science ®Google Scholar
• Dannenberg AM Jr. Perspectives on clinical and preclinical testing of new tuberculosis vaccines. Clin. Microbiol. Rev.23(4), 781–794 (2010).
   PubMed Web of Science ®Google Scholar
• Hewinson RG, Vordermeier HM, Buddle BM. Use of the bovine model of tuberculosis for the development of improved vaccines and diagnostics. Tuberculosis (Edinb.)83(1–3), 119–130 (2003).
   PubMedGoogle Scholar
• Dheda K, Schwander SK, Zhu B, Van Zyl-Smit RN, Zhang Y. The immunology of tuberculosis: from bench to bedside. Respirology15(3), 433–450 (2010).
   PubMed Web of Science ®Google Scholar
• Flynn JL. Immunology of tuberculosis and implications in vaccine development. Tuberculosis (Edinb.)84(1–2), 93–101 (2004).
   PubMed Web of Science ®Google Scholar
• Kagina BM, Abel B, Scriba TJ et al. 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(8), 1073–1079 (2010).
   PubMed Web of Science ®Google Scholar
• Saunders BM, Frank AA, Orme IM, Cooper AM. CD4 is required for the development of a protective granulomatous response to pulmonary tuberculosis. Cell. Immunol.216(1–2), 65–72 (2002).
   PubMed Web of Science ®Google Scholar
• Keane J, Gershon S, Wise RP et al. Tuberculosis associated with infliximab, a tumor necrosis factor α-neutralizing agent. N. Engl. J. Med.345(15), 1098–1104 (2001).
   PubMed Web of Science ®Google Scholar
• Feng CG, Britton WJ. CD4+ and CD8+ T cells mediate adoptive immunity to aerosol infection of Mycobacterium bovis bacillus Calmette–Guérin. J. Infect. Dis.181(5), 1846–1849 (2000).
   PubMed Web of Science ®Google Scholar
• Havlir DV, Barnes PF. Tuberculosis in patients with human immunodeficiency virus infection. N. Engl. J. Med.340(5), 367–373 (1999).
   PubMed Web of Science ®Google Scholar
• Ottenhoff TH, Kumararatne D, Casanova JL. Novel human immunodeficiencies reveal the essential role of type-I cytokines in immunity to intracellular bacteria. Immunol. Today19(11), 491–494 (1998).
   PubMedGoogle Scholar
• Ladel CH, Daugelat S, Kaufmann SH. Immune response to Mycobacterium bovis bacille Calmette–Guérin infection in major histocompatibility complex class I- and II-deficient knock-out mice: contribution of CD4 and CD8 T cells to acquired resistance. Eur. J. Immunol.25(2), 377–384 (1995).
   PubMed Web of Science ®Google Scholar
• Flynn JL, Goldstein MM, Triebold KJ, Koller B, Bloom BR. Major histocompatibility complex class I-restricted T cells are required for resistance to Mycobacterium tuberculosis infection. Proc. Natl Acad. Sci. USA89(24), 12013–12017 (1992).
   PubMed Web of Science ®Google Scholar
• Van Pinxteren LA, Cassidy JP, Smedegaard BH, Agger EM, Andersen P. Control of latent Mycobacterium tuberculosis infection is dependent on CD8 T cells. Eur. J. Immunol.30(12), 3689–3698 (2000).
   PubMed Web of Science ®Google Scholar
• Soares AP, Scriba TJ, Joseph S et al. Bacillus Calmette–Guérin vaccination of human newborns induces T cells with complex cytokine and phenotypic profiles. J. Immunol.180(5), 3569–3577 (2008).
   PubMed Web of Science ®Google Scholar
• Newport MJ, Huxley CM, Huston S et al. A mutation in the interferon-γ-receptor gene and susceptibility to mycobacterial infection. N. Engl. J. Med.335(26), 1941–1949 (1996).
   PubMed Web of Science ®Google Scholar
• Flynn JL, Chan J, Triebold KJ, Dalton DK, Stewart TA, Bloom BR. An essential role for interferon γ in resistance to Mycobacterium tuberculosis infection. J. Exp. Med.178(6), 2249–2254 (1993).
   PubMed Web of Science ®Google Scholar
• Seder RA, Darrah PA, Roederer M. T-cell quality in memory and protection: implications for vaccine design. Nat. Rev. Immunol.8(4), 247–258 (2008).
   PubMed Web of Science ®Google Scholar
• Cooper AM. Cell-mediated immune responses in tuberculosis. Annu. Rev. Immunol.27, 393–422 (2009).
   PubMed Web of Science ®Google Scholar
• Beveridge NE, Fletcher HA, Hughes J et al. A comparison of IFNγ detection methods used in tuberculosis vaccine trials. Tuberculosis (Edinb.)88(6), 631–640 (2008).
   PubMed Web of Science ®Google Scholar
• Mcshane H, Pathan AA, Sander CR et al. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat. Med.10(11), 1240–1244 (2004).
   PubMed Web of Science ®Google Scholar
• Hanekom WA, Hughes J, Mavinkurve M et al. Novel application of a whole blood intracellular cytokine detection assay to quantitate specific T-cell frequency in field studies. J. Immunol. Methods291(1–2), 185–195 (2004).
   PubMed Web of Science ®Google Scholar
• Wallis RS, Vinhas SA, Johnson JL et al. Whole blood bactericidal activity during treatment of pulmonary tuberculosis. J. Infect. Dis.187(2), 270–278 (2003).
   PubMed Web of Science ®Google Scholar
• Li Q, Whalen CC, Albert JM et al. Differences in rate and variability of intracellular growth of a panel of Mycobacterium tuberculosis clinical isolates within a human monocyte model. Infect. Immun.70(11), 6489–6493 (2002).
   PubMedGoogle Scholar
• Kampmann B, Gaora PO, Snewin VA, Gares MP, Young DB, Levin M. Evaluation of human antimycobacterial immunity using recombinant reporter mycobacteria. J. Infect. Dis.182(3), 895–901 (2000).
   PubMed Web of Science ®Google Scholar
• Worku S, Hoft DF. In vitro measurement of protective mycobacterial immunity: antigen-specific expansion of T cells capable of inhibiting intracellular growth of Bacille Calmette–Guérin. Clin. Infect. Dis.30(Suppl. 3), S257–S261 (2000).
   PubMed Web of Science ®Google Scholar
• Hohn H, Kortsik C, Zehbe I et al. MHC class II tetramer guided detection of Mycobacterium tuberculosis-specific CD4+ T cells in peripheral blood from patients with pulmonary tuberculosis. Scand. J. Immunol.65(5), 467–478 (2007).
   PubMedGoogle Scholar
• Hanekom WA, Dockrell HM, Ottenhoff TH et al. Immunological outcomes of new tuberculosis vaccine trials: WHO panel recommendations. PLoS Med.5(7), e145 (2008).
   PubMed Web of Science ®Google Scholar
• Crampin AC, Glynn JR, Fine PE. What has Karonga taught us? Tuberculosis studied over three decades. Int. J. Tuberc. Lung Dis.13(2), 153–164 (2009).
   PubMed Web of Science ®Google Scholar
• Rodrigues LC, Diwan VK, Wheeler JG. Protective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. Int. J. Epidemiol.22(6), 1154–1158 (1993).
   PubMed Web of Science ®Google Scholar
• Roth AE, Benn CS, Ravn H et al. Effect of revaccination with BCG in early childhood on mortality: randomised trial in Guinea-Bissau. BMJ340, c671 (2010).
   Google Scholar
• Whelan KT, Pathan AA, Sander CR et al. Safety and immunogenicity of boosting BCG vaccinated subjects with BCG: comparison with boosting with a new TB vaccine, MVA85A. PLoS ONE4(6), e5934 (2009).
   PubMed Web of Science ®Google Scholar
• Yamamoto S, Yamamoto T. Historical review of BCG vaccine in Japan. Jpn J. Infect. Dis.60(6), 331–336 (2007).
   PubMedGoogle Scholar
• Jeena PM, Chhagan MK, Topley J, Coovadia HM. Safety of the intradermal Copenhagen 1331 BCG vaccine in neonates in Durban, South Africa. Bull. World Health Organ.79(4), 337–343 (2001).
   PubMed Web of Science ®Google Scholar
• Mahomed H, Kibel M, Hawkridge T et al. The impact of a change in bacille Calmette–Guérin vaccine policy on tuberculosis incidence in children in Cape Town, South Africa. Pediatr. Infect. Dis. J.25(12), 1167–1172 (2006).
   PubMed Web of Science ®Google Scholar
• Davids V, Hanekom WA, Mansoor N et al. The effect of bacille Calmette–Guérin vaccine strain and route of administration on induced immune responses in vaccinated infants. J. Infect. Dis.193(4), 531–536 (2006).
   PubMed Web of Science ®Google Scholar
• Hawkridge A, Hatherill M, Little F et al. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ337, a2052 (2008).
   PubMed Web of Science ®Google Scholar
• Hoft DF, Brown RM, Belshe RB. Mucosal bacille Calmette–Guérin vaccination of humans inhibits delayed-type hypersensitivity to purified protein derivative but induces mycobacteria-specific interferon-γ responses. Clin. Infect. Dis.30(Suppl. 3), S217–S222 (2000).
   PubMed Web of Science ®Google Scholar
• Cosgrove CA, Castello-Branco LR, Hussell T et al. Boosting of cellular immunity against Mycobacterium tuberculosis and modulation of skin cytokine responses in healthy human volunteers by Mycobacterium bovis BCG substrain Moreau Rio de Janeiro oral vaccine. Infect. Immun.74(4), 2449–2452 (2006).
   PubMed Web of Science ®Google Scholar
• Buddle BM, Aldwell FE, Corner LAL. Progress in the development of tuberculosis vaccines for wildlife. CAB Reviews. Perspectives in Agriculture, Veterinary Science, Nutrition and Natural Resources4(030), 1–10 (2009).
   Google Scholar
• 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.74(8), 4634–4643 (2006).
   PubMed Web of Science ®Google Scholar
• Wang J, Thorson L, Stokes RW et al. Single mucosal, but not parenteral, immunization with recombinant adenoviral-based vaccine provides potent protection from pulmonary tuberculosis. J. Immunol.173(10), 6357–6365 (2004).
   PubMed Web of Science ®Google Scholar
• Goonetilleke NP, McShane H, Hannan CM, Anderson RJ, Brookes RH, Hill AV. Enhanced immunogenicity and protective efficacy against Mycobacterium tuberculosis of Bacille Calmette–Guérin vaccine using mucosal administration and boosting with a recombinant modified vaccinia virus Ankara. J. Immunol.171(3), 1602–1609 (2003).
   PubMed Web of Science ®Google Scholar
• Kagina BM, Abel B, Bowmaker M et al. Delaying BCG vaccination from birth to 10 weeks of age may result in an enhanced memory CD4 T cell response. Vaccine27(40), 5488–5495 (2009).
   PubMed Web of Science ®Google Scholar
• Burl S, Adetifa UJ, Cox M et al. Delaying bacillus Calmette–Guérin 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.185(4), 2620–2628 (2010).
   PubMed Web of Science ®Google Scholar
• Roth AE, Stensballe LG, Garly ML, Aaby P. Beneficial non-targeted effects of BCG – ethical implications for the coming introduction of new TB vaccines. Tuberculosis (Edinb.)86(6), 397–403 (2006).
   PubMed Web of Science ®Google Scholar
• Villamor E, Fawzi WW. Effects of vitamin A supplementation on immune responses and correlation with clinical outcomes. Clin. Microbiol. Rev.18(3), 446–464 (2005).
   PubMed Web of Science ®Google Scholar
• Benn CS, Diness BR, Roth A et al. Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial. BMJ336(7658), 1416–1420 (2008).
   PubMedGoogle Scholar
• Diness BR, Fisker AB, Roth A et al. Effect of high-dose vitamin A supplementation on the immune response to Bacille Calmette–Guérin vaccine. Am. J. Clin. Nutr.86(4), 1152–1159 (2007).
   PubMed Web of Science ®Google Scholar
• Benn CS, Fisker AB, Napirna BM et al. Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial. BMJ340, c1101 (2010).
   Google Scholar
• Perez E, Samper S, Bordas Y, Guilhot C, Gicquel B, Martin C. An essential role for phoP in Mycobacterium tuberculosis virulence. Mol. Microbiol.41(1), 179–187 (2001).
   PubMed Web of Science ®Google Scholar
• Cardona PJ, Asensio JG, Arbues A et al. Extended safety studies of the attenuated live tuberculosis vaccine SO2 based on phoP mutant. Vaccine27(18), 2499–2505 (2009).
   PubMed Web of Science ®Google Scholar
• Verreck FA, Vervenne RA, Kondova I et al. MVA.85A boosting of BCG and an attenuated, phoP deficient M. tuberculosis vaccine both show protective efficacy against tuberculosis in rhesus macaques. PLoS ONE4(4), e5264 (2009).
   PubMed Web of Science ®Google Scholar
• Martin C, Williams A, Hernandez-Pando R et al. The live Mycobacterium tuberculosis phoP mutant strain is more attenuated than BCG and confers protective immunity against tuberculosis in mice and guinea pigs. Vaccine24(17), 3408–3419 (2006).
   PubMed Web of Science ®Google Scholar
• Larsen MH, Biermann K, Chen B et al. Efficacy and safety of live attenuated persistent and rapidly cleared Mycobacterium tuberculosis vaccine candidates in non-human primates. Vaccine27(34), 4709–4717 (2009).
   PubMed Web of Science ®Google Scholar
• Sambandamurthy VK, Derrick SC, Hsu T et al. Mycobacterium tuberculosis δRD1 δpanCD: a safe and limited replicating mutant strain that protects immunocompetent and immunocompromised mice against experimental tuberculosis. Vaccine24(37–39), 6309–6320 (2006).
   PubMed Web of Science ®Google Scholar
• Sambandamurthy VK, Derrick SC, Jalapathy KV et al. Long-term protection against tuberculosis following vaccination with a severely attenuated double lysine and pantothenate auxotroph of Mycobacterium tuberculosis. Infect. Immun.73(2), 1196–1203 (2005).
   PubMed Web of Science ®Google Scholar
• Walker KB, Brennan MJ, Ho MM et al. The second Geneva Consensus: recommendations for novel live TB vaccines. Vaccine28(11), 2259–2270 (2010).
   PubMedGoogle Scholar
• Kamath AT, Fruth U, Brennan MJ et al. New live mycobacterial vaccines: the Geneva Consensus on essential steps towards clinical development. Vaccine23(29), 3753–3761 (2005).
   PubMed Web of Science ®Google Scholar
• Grode L, Seiler P, Baumann S et al. Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette–Guérin mutants that secrete listeriolysin. J. Clin. Invest.115(9), 2472–2479 (2005).
   PubMed Web of Science ®Google Scholar
• Winau F, Weber S, Sad S et al. Apoptotic vesicles crossprime CD8 T cells and protect against tuberculosis. Immunity24(1), 105–117 (2006).
   PubMed Web of Science ®Google Scholar
• Horwitz MA, Harth G, Dillon BJ, Maslesa-Galic S. Recombinant bacillus Calmette–Guérin (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. USA97(25), 13853–13858 (2000).
   PubMed Web of Science ®Google Scholar
• 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.71(4), 1672–1679 (2003).
   PubMed Web of Science ®Google Scholar
• Hoft DF, Blazevic A, Abate G et al. A new recombinant Bacille Calmette–Guérin vaccine safely induces significantly enhanced tuberculosis-specific immunity in human volunteers. J. Infect. Dis.198(10), 1491–1501 (2008).
   PubMed Web of Science ®Google Scholar
• Sun R, Skeiky YA, Izzo A et al. Novel recombinant BCG expressing perfringolysin O and the over-expression of key immunodominant antigens; pre-clinical characterization, safety and protection against challenge with Mycobacterium tuberculosis. Vaccine27(33), 4412–4423 (2009).
   PubMed Web of Science ®Google Scholar
• Mayr A, Stickl H, Muller HK, Danner K, Singer H. The smallpox vaccination strain MVA: marker, genetic structure, experience gained with the parenteral vaccination and behavior in organisms with a debilitated defence mechanism. Zentralbl. Bakteriol. B167(5–6), 375–390 (1978).
   PubMedGoogle Scholar
• Cosma A, Nagaraj R, Staib C et al. Evaluation of modified vaccinia virus Ankara as an alternative vaccine against smallpox in chronically HIV type 1-infected individuals undergoing HAART. AIDS Res. Hum. Retroviruses23(6), 782–793 (2007).
   PubMed Web of Science ®Google Scholar
• Tatsis N, Ertl HC. Adenoviruses as vaccine vectors. Mol. Ther.10(4), 616–629 (2004).
   PubMed Web of Science ®Google Scholar
• Mcshane H, Brookes R, Gilbert SC, Hill AV. Enhanced immunogenicity of CD4(+) T-cell responses and protective efficacy of a DNA-modified vaccinia virus Ankara prime–boost vaccination regimen for murine tuberculosis. Infect. Immun.69(2), 681–686 (2001).
   PubMed Web of Science ®Google Scholar
• Williams A, Goonetilleke NP, McShane H et al. Boosting with poxviruses enhances Mycobacterium bovis BCG efficacy against tuberculosis in guinea pigs. Infect. Immun.73(6), 3814–3816 (2005).
   PubMed Web of Science ®Google Scholar
• Vordermeier HM, Villarreal-Ramos B, Cockle PJ. et al. Viral booster vaccines improve Mycobacterium bovis BCG-induced protection against bovine tuberculosis. Infect. Immun.77(8), 3364–3373 (2009).
   PubMed Web of Science ®Google Scholar
• Sander CR, Pathan AA, Beveridge NE et al. Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in Mycobacterium tuberculosis-infected individuals. Am. J. Respir. Crit. Care Med.179(8), 724–733 (2009).
   PubMed Web of Science ®Google Scholar
• Pathan AA, Sander CR, Fletcher HA et al. Boosting BCG with recombinant modified vaccinia Ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials. PLoS ONE2(10), e1052 (2007).
   PubMedGoogle Scholar
• Scriba TJ, Tameris M, Mansoor N et al. Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells. Eur. J. Immunol.40(1), 279–290 (2010).
   PubMed Web of Science ®Google Scholar
• Brookes RH, Hill PC, Owiafe PK et al. Safety and immunogenicity of the candidate tuberculosis vaccine MVA85A in West Africa. PLoS ONE3(8), e2921 (2008).
   PubMed Web of Science ®Google Scholar
• Hawkridge T, Scriba TJ, Gelderbloem S et al. Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa. J. Infect. Dis.198(4), 544–552 (2008).
   PubMed Web of Science ®Google Scholar
• Ibanga HB, Brookes RH, Hill PC et al. Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. Lancet Infect. Dis.6(8), 522–528 (2006).
   PubMed Web of Science ®Google Scholar
• Beveridge NE, Price DA, Casazza JP et al. Immunisation with BCG and recombinant MVA85A induces long-lasting, polyfunctional Mycobacterium tuberculosis-specific CD4+ memory T lymphocyte populations. Eur. J. Immunol.37(11), 3089–3100 (2007).
   PubMed Web of Science ®Google Scholar
• Radosevic K, Wieland CW, Rodriguez A 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 γ interferon. Infect. Immun.75(8), 4105–4115 (2007).
   PubMed Web of Science ®Google Scholar
• Barouch DH, Pau MG, Custers JH et al. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J. Immunol.172(10), 6290–6297 (2004).
   PubMed Web of Science ®Google Scholar
• Kostense S, Koudstaal W, Sprangers M et al. Adenovirus types 5 and 35 seroprevalence in AIDS risk groups supports type 35 as a vaccine vector. AIDS18(8), 1213–1216 (2004).
   PubMed Web of Science ®Google Scholar
• Vogels R, Zuijdgeest D, Van Rijnsoever R 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.77(15), 8263–8271 (2003).
   PubMed Web of Science ®Google Scholar
• Abel B, Tameris M, Mansoor N 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.181(12), 1407–1417 (2010).
   PubMed Web of Science ®Google Scholar
• Xing Z, McFarland CT, Sallenave JM, Izzo A, Wang J, McMurray DN. Intranasal mucosal boosting with an adenovirus-vectored vaccine markedly enhances the protection of BCG-primed guinea pigs against pulmonary tuberculosis. PLoS ONE4(6), e5856 (2009).
   PubMed Web of Science ®Google Scholar
• Lasaro MO, Ertl HC. New insights on adenovirus as vaccine vectors. Mol. Ther.17(8), 1333–1339 (2009).
   PubMed Web of Science ®Google Scholar
• Buchbinder SP, Mehrotra DV, Duerr A et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet372(9653), 1881–1893 (2008).
   PubMed Web of Science ®Google Scholar
• Reed SG, Bertholet S, Coler RN, Friede M. New horizons in adjuvants for vaccine development. Trends Immunol.30(1), 23–32 (2009).
   PubMed Web of Science ®Google Scholar
• Pashine A, Valiante NM, Ulmer JB. Targeting the innate immune response with improved vaccine adjuvants. Nat. Med.11(Suppl. 4), S63–S68 (2005).
   PubMed Web of Science ®Google Scholar
• Skeiky YA, Alderson MR, Ovendale PJ et al. Differential immune responses and protective efficacy induced by components of a tuberculosis polyprotein vaccine, Mtb72F, delivered as naked DNA or recombinant protein. J. Immunol.172(12), 7618–7628 (2004).
   PubMed Web of Science ®Google Scholar
• Pichichero ME. Improving vaccine delivery using novel adjuvant systems. Hum. Vaccin.4(4), 262–270 (2008).
   PubMed Web of Science ®Google Scholar
• Sacarlal J, Aide P, Aponte JJ et al. Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J. Infect. Dis.200(3), 329–336 (2009).
   PubMed Web of Science ®Google Scholar
• Reed SG, Coler RN, Dalemans W et al. Defined tuberculosis vaccine, Mtb72F/AS02A, evidence of protection in cynomolgus monkeys. Proc. Natl Acad. Sci. USA106(7), 2301–2306 (2009).
   PubMed Web of Science ®Google Scholar
• Brandt L, Skeiky YA, Alderson MR et al. The protective effect of the Mycobacterium bovis BCG vaccine is increased by coadministration with the Mycobacterium tuberculosis 72-kilodalton fusion polyprotein Mtb72F in M. tuberculosis-infected guinea pigs. Infect. Immun.72(11), 6622–6632 (2004).
   PubMed Web of Science ®Google Scholar
• Von Eschen K, Morrison R, Braun M et al. The candidate tuberculosis vaccine Mtb72F/AS02A: tolerability and immunogenicity in humans. Hum. Vaccin.5(7), 475–482 (2009).
   PubMed Web of Science ®Google Scholar
• Weinrich Olsen A, Van Pinxteren LA, Meng Okkels L, Birk Rasmussen P, Andersen P. Protection of mice with a tuberculosis subunit vaccine based on a fusion protein of antigen 85b and ESAT-6. Infect. Immun.69(5), 2773–2778 (2001).
   PubMed Web of Science ®Google Scholar
• Doherty TM, Olsen AW, Weischenfeldt J et al. Comparative analysis of different vaccine constructs expressing defined antigens from Mycobacterium tuberculosis. J. Infect. Dis.190(12), 2146–2153 (2004).
   PubMed Web of Science ®Google Scholar
• Williams A, Hatch GJ, Clark SO et al. Evaluation of vaccines in the EU TB vaccine cluster using a guinea pig aerosol infection model of tuberculosis. Tuberculosis (Edinb.)85(1–2), 29–38 (2005).
   PubMed Web of Science ®Google Scholar
• Langermans JA, Doherty TM, Vervenne RA et al. Protection of macaques against Mycobacterium tuberculosis infection by a subunit vaccine based on a fusion protein of antigen 85B and ESAT-6. Vaccine23(21), 2740–2750 (2005).
   PubMed Web of Science ®Google Scholar
• Schellack C, Prinz K, Egyed A et al. IC31, a novel adjuvant signaling via TLR9, induces potent cellular and humoral immune responses. Vaccine24(26), 5461–5472 (2006).
   PubMed Web of Science ®Google Scholar
• Kamath AT, Rochat AF, Valenti MP et al. Adult-like anti-mycobacterial T cell and in vivo dendritic cell responses following neonatal immunization with Ag85B-ESAT-6 in the IC31 adjuvant. PLoS ONE3(11), e3683 (2008).
   Google Scholar
• Agger EM, Rosenkrands I, Olsen AW et al. Protective immunity to tuberculosis with Ag85B–ESAT-6 in a synthetic cationic adjuvant system IC31. Vaccine24(26), 5452–5460 (2006).
   PubMed Web of Science ®Google Scholar
• Van Dissel JT, Arend SM, Prins C et al. Ag85B–ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine28(20), 3571–3581 (2010).
   PubMed Web of Science ®Google Scholar
• Kamath AT, Rochat AF, Christensen D et al. A liposome-based mycobacterial vaccine induces potent adult and neonatal multifunctional T cells through the exquisite targeting of dendritic cells. PLoS ONE4(6), e5771 (2009).
   PubMed Web of Science ®Google Scholar
• Agger EM, Rosenkrands I, Hansen J. et al. Cationic liposomes formulated with synthetic mycobacterial cordfactor (CAF01): a versatile adjuvant for vaccines with different immunological requirements. PLoS ONE3(9), e3116 (2008).
   PubMed Web of Science ®Google Scholar
• Davidsen J, Rosenkrands I, Christensen D et al. Characterization of cationic liposomes based on dimethyldioctadecylammonium and synthetic cord factor from M. tuberculosis (trehalose 6,6’-dibehenate)-a novel adjuvant inducing both strong CMI and antibody responses. Biochim. Biophys. Acta1718(1–2), 22–31 (2005).
   PubMed Web of Science ®Google Scholar
• Hervas-Stubbs S, Majlessi L, Simsova M et al. High frequency of CD4+ T cells specific for the TB10.4 protein correlates with protection against Mycobacterium tuberculosis infection. Infect. Immun.74(6), 3396–3407 (2006).
   PubMed Web of Science ®Google Scholar
• Dietrich J, Aagaard C, Leah R et al. Exchanging ESAT6 with TB10.4 in an Ag85B fusion molecule-based tuberculosis subunit vaccine: efficient protection and ESAT6-based sensitive monitoring of vaccine efficacy. J. Immunol.174(10), 6332–6339 (2005).
   PubMed Web of Science ®Google Scholar
• Skeiky YA, Dietrich J, Lasco TM et al. Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime–boost regimen. Vaccine28(4), 1084–1093 (2010).
   PubMed Web of Science ®Google Scholar
• Stanford JL, Rook GA, Bahr GM et al. Mycobacterium vaccae in immunoprophylaxis and immunotherapy of leprosy and tuberculosis. Vaccine8(6), 525–530 (1990).
   PubMedGoogle Scholar
• Mayo RE, Stanford JL. Double-blind placebo-controlled trial of Mycobacterium vaccae immunotherapy for tuberculosis in KwaZulu, South Africa, 1991–1997. Trans. R. Soc. Trop. Med. Hyg.94(5), 563–568 (2000).
   PubMed Web of Science ®Google Scholar
• Mwinga A, Nunn A, Ngwira B et al. Mycobacterium vaccae (SRL172) immunotherapy as an adjunct to standard antituberculosis treatment in HIV-infected adults with pulmonary tuberculosis: a randomised placebo-controlled trial. Lancet360(9339), 1050–1055 (2002).
   PubMed Web of Science ®Google Scholar
• 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.100(6), 1079–1087 (2006).
   PubMed Web of Science ®Google Scholar
• Johnson JL, Kamya RM, Okwera A 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.181(4), 1304–1312 (2000).
   PubMedGoogle Scholar
• Von Reyn CF, Mtei L, Arbeit RD et al. Prevention of tuberculosis in Bacille Calmette–Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. AIDS24(5), 675–685 (2010).
   PubMed Web of Science ®Google Scholar
• Vilaplana C, Montane E, Pinto S et al. Double-blind, randomized, placebo-controlled Phase I clinical trial of the therapeutical antituberculous vaccine RUTI. Vaccine28(4), 1106–1116 (2010).
   PubMed Web of Science ®Google Scholar
• Parida SK, Kaufmann SH. The quest for biomarkers in tuberculosis. Drug Discov. Today15(3–4), 148–157 (2010).
   PubMed Web of Science ®Google Scholar
• Brennan MJ, Fruth U, Milstien J, Tiernan R, De Andrade Nishioka S, Chocarro L. Development of new tuberculosis vaccines: a global perspective on regulatory issues. PLoS Med.4(8), e252 (2007).
   PubMed Web of Science ®Google Scholar