메뉴 건너뛰기




Volumn 31, Issue 9, 2013, Pages 1340-1348

Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial

Author keywords

BCG; Clinical trial; Immune response; Safety; Tuberculosis; Vaccination

Indexed keywords

BACTERIAL ANTIGEN; BCG VACCINE; GAMMA INTERFERON; RECOMBINANT VACCINE;

EID: 84873446135     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.12.053     Document Type: Article
Times cited : (165)

References (42)
  • 2
    • 0003635217 scopus 로고    scopus 로고
    • World Health Organization, Geneva, WHO
    • WHO Global tuberculosis control 2011 2011, World Health Organization, Geneva.
    • (2011) Global tuberculosis control 2011
  • 3
    • 77952549306 scopus 로고    scopus 로고
    • Tuberculosis control and elimination 2010-50: cure, care, and social development
    • Lonnroth K., Castro K.G., Chakaya J.M., Chauhan L.S., Floyd K., Glaziou P., et al. Tuberculosis control and elimination 2010-50: cure, care, and social development. Lancet 2010, 375(May (9728)):1814-1829.
    • (2010) Lancet , vol.375 , Issue.MAY 9728 , pp. 1814-1829
    • Lonnroth, K.1    Castro, K.G.2    Chakaya, J.M.3    Chauhan, L.S.4    Floyd, K.5    Glaziou, P.6
  • 4
    • 33749077283 scopus 로고    scopus 로고
    • Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review
    • Steingart K.R., Ng V., Henry M., Hopewell P.C., Ramsay A., Cunningham J., et al. Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis 2006, 6(October (10)):664-674.
    • (2006) Lancet Infect Dis , vol.6 , Issue.OCTOBER 10 , pp. 664-674
    • Steingart, K.R.1    Ng, V.2    Henry, M.3    Hopewell, P.C.4    Ramsay, A.5    Cunningham, J.6
  • 5
    • 77952892091 scopus 로고    scopus 로고
    • Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice
    • May (9729)
    • Wallis R.S., Pai M., Menzies D., Doherty T.M., Walzl G., Perkins M.D., et al. Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. Lancet 2010, 375(May (9729)):1920-1937.
    • (2010) Lancet , vol.375 , pp. 1920-1937
    • Wallis, R.S.1    Pai, M.2    Menzies, D.3    Doherty, T.M.4    Walzl, G.5    Perkins, M.D.6
  • 7
    • 79960677601 scopus 로고    scopus 로고
    • Fact and fiction in tuberculosis vaccine research: 10 years later
    • Kaufmann S.H. Fact and fiction in tuberculosis vaccine research: 10 years later. Lancet Infect Dis 2011, 11(August (8)):633-640.
    • (2011) Lancet Infect Dis , vol.11 , Issue.AUGUST 8 , pp. 633-640
    • Kaufmann, S.H.1
  • 8
    • 33845197461 scopus 로고    scopus 로고
    • The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children
    • Hesseling A.C., Marais B.J., Gie R.P., Schaaf H.S., Fine P.E., Godfrey-Faussett P., et al. The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children. Vaccine 2007, 25(January (1)):14-18.
    • (2007) Vaccine , vol.25 , Issue.JANUARY 1 , pp. 14-18
    • Hesseling, A.C.1    Marais, B.J.2    Gie, R.P.3    Schaaf, H.S.4    Fine, P.E.5    Godfrey-Faussett, P.6
  • 10
    • 0023189876 scopus 로고
    • Purification, characterization, and toxicity of the sulfhydryl-activated hemolysin listeriolysin O from Listeria monocytogenes
    • Geoffroy C., Gaillard J.L., Alouf J.E., Berche P. Purification, characterization, and toxicity of the sulfhydryl-activated hemolysin listeriolysin O from Listeria monocytogenes. Infect Immun 1987, 55(July (7)):1641-1646.
    • (1987) Infect Immun , vol.55 , Issue.JULY 7 , pp. 1641-1646
    • Geoffroy, C.1    Gaillard, J.L.2    Alouf, J.E.3    Berche, P.4
  • 11
    • 22344433382 scopus 로고    scopus 로고
    • Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guérin mutants that secrete listeriolysin
    • Grode L., Seiler P., Baumann S., Hess J., Brinkmann V., Nasser Eddine A., et al. Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guérin mutants that secrete listeriolysin. J Clin Invest 2005, 115(9):2472-2479.
    • (2005) J Clin Invest , vol.115 , Issue.9 , pp. 2472-2479
    • Grode, L.1    Seiler, P.2    Baumann, S.3    Hess, J.4    Brinkmann, V.5    Nasser Eddine, A.6
  • 12
    • 84870546622 scopus 로고    scopus 로고
    • The recombinant tuberculosis vaccine rBCG ΔureC::hly+ induces apoptotic vescicles for improved priming of CD4+ and CD8+ T cells
    • Farinacci M., Weber S., Kaufmann S.H.E. The recombinant tuberculosis vaccine rBCG ΔureC::hly+ induces apoptotic vescicles for improved priming of CD4+ and CD8+ T cells. Vaccine 2012, 10.1016/j.vaccine.2012.10.031.
    • (2012) Vaccine
    • Farinacci, M.1    Weber, S.2    Kaufmann, S.H.E.3
  • 13
    • 83655192826 scopus 로고    scopus 로고
    • PH dependence of listeriolysin O aggregation and pore-forming ability
    • Bavdek A., Kostanjsek R., Antonini V., Lakey J.H., Dalla S.M., Gilbert R.J., et al. pH dependence of listeriolysin O aggregation and pore-forming ability. FEBS J 2012, 279(January (1)):126-141.
    • (2012) FEBS J , vol.279 , Issue.JANUARY 1 , pp. 126-141
    • Bavdek, A.1    Kostanjsek, R.2    Antonini, V.3    Lakey, J.H.4    Dalla, S.M.5    Gilbert, R.J.6
  • 14
    • 0034602312 scopus 로고    scopus 로고
    • A PEST-like sequence in listeriolysin O essential for Listeria monocytogenes pathogenicity
    • Decatur A.L., Portnoy D.A. A PEST-like sequence in listeriolysin O essential for Listeria monocytogenes pathogenicity. Science 2000, 290(November (5493)):992-995.
    • (2000) Science , vol.290 , Issue.NOVEMBER 5493 , pp. 992-995
    • Decatur, A.L.1    Portnoy, D.A.2
  • 15
    • 33644819006 scopus 로고    scopus 로고
    • Phosphorylation, ubiquitination and degradation of listeriolysin O in mammalian cells: role of the PEST-like sequence
    • Schnupf P., Portnoy D.A., Decatur A.L. Phosphorylation, ubiquitination and degradation of listeriolysin O in mammalian cells: role of the PEST-like sequence. Cell Microbiol 2006, 8(February (2)):353-364.
    • (2006) Cell Microbiol , vol.8 , Issue.FEBRUARY 2 , pp. 353-364
    • Schnupf, P.1    Portnoy, D.A.2    Decatur, A.L.3
  • 16
    • 80054745408 scopus 로고    scopus 로고
    • Recombinant BCG ΔureC hly+ induces superior protection over parental BCG by stimulating a balanced combination of type 1 and type 17 cytokine responses
    • Desel C., Dorhoi A., Bandermann S., Grode L., Eisele B., Kaufmann S.H. Recombinant BCG ΔureC 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(September (10)):1573-1584.
    • (2011) J Infect Dis , vol.204 , Issue.SEPTEMBER 10 , pp. 1573-1584
    • Desel, C.1    Dorhoi, A.2    Bandermann, S.3    Grode, L.4    Eisele, B.5    Kaufmann, S.H.6
  • 17
    • 0002508295 scopus 로고
    • World Medical Association
    • Declaration of Helsinki (revised 2008);
    • World Medical Association. Declaration of Helsinki (revised 2008); 1964.
    • (1964)
  • 18
    • 84873421192 scopus 로고    scopus 로고
    • WHO. Expert Committee on Biological Standardization: Recommendations to assure the quality
    • Safety and efficacy of BCG vaccines.
    • WHO. Expert Committee on Biological Standardization: Recommendations to assure the quality, safety and efficacy of BCG vaccines. http://www%20who%20int/biologicals/BCG_DB_HK_23_April_2012%20pdf%202011.
  • 20
    • 83755205793 scopus 로고    scopus 로고
    • A new synthesis for antibody-mediated immunity
    • Casadevall A., Pirofski L.A. A new synthesis for antibody-mediated immunity. Nat Immunol 2012, 13(January (1)):21-28.
    • (2012) Nat Immunol , vol.13 , Issue.JANUARY 1 , pp. 21-28
    • Casadevall, A.1    Pirofski, L.A.2
  • 21
    • 83755163040 scopus 로고    scopus 로고
    • Infectious disease. Taking a new shot at a TB vaccine
    • Kupferschmidt K. Infectious disease. Taking a new shot at a TB vaccine. Science 2011, 334(December (6062)):1488-1490.
    • (2011) Science , vol.334 , Issue.DECEMBER 6062 , pp. 1488-1490
    • Kupferschmidt, K.1
  • 22
    • 67649321241 scopus 로고    scopus 로고
    • 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
    • Sun R., Skeiky Y.A., Izzo A., Dheenadhayalan V., Imam Z., Penn E., 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. Vaccine 2009, 27(July (33)):4412-4423.
    • (2009) Vaccine , vol.27 , Issue.JULY 33 , pp. 4412-4423
    • Sun, R.1    Skeiky, Y.A.2    Izzo, A.3    Dheenadhayalan, V.4    Imam, Z.5    Penn, E.6
  • 23
    • 22344448429 scopus 로고    scopus 로고
    • Properties and protective value of the secondary versus primary T helper type 1 response to airborne Mycobacterium tuberculosis infection in mice
    • Jung Y.J., Ryan L., Lacourse R., North R.J. Properties and protective value of the secondary versus primary T helper type 1 response to airborne Mycobacterium tuberculosis infection in mice. J Exp Med 2005, 201(June (12)):1915-1924.
    • (2005) J Exp Med , vol.201 , Issue.JUNE 12 , pp. 1915-1924
    • Jung, Y.J.1    Ryan, L.2    Lacourse, R.3    North, R.J.4
  • 24
    • 55149102403 scopus 로고    scopus 로고
    • Inborn errors of interferon (IFN)-mediated immunity in humans: insights into the respective roles of IFN-alpha/beta, IFN-gamma, and IFN-lambda in host defense
    • Zhang S.Y., Boisson-Dupuis S., Chapgier A., Yang K., Bustamante J., Puel A., et al. Inborn errors of interferon (IFN)-mediated immunity in humans: insights into the respective roles of IFN-alpha/beta, IFN-gamma, and IFN-lambda in host defense. Immunol Rev 2008, 226(December):29-40.
    • (2008) Immunol Rev , vol.226 , Issue.DECEMBER , pp. 29-40
    • Zhang, S.Y.1    Boisson-Dupuis, S.2    Chapgier, A.3    Yang, K.4    Bustamante, J.5    Puel, A.6
  • 25
    • 79955777383 scopus 로고    scopus 로고
    • A family of IFN-gamma-inducible 65-kD GTPases protects against bacterial infection
    • Kim B.H., Shenoy A.R., Kumar P., Das R., Tiwari S., MacMicking J.D. A family of IFN-gamma-inducible 65-kD GTPases protects against bacterial infection. Science 2011, 332(May (6030)):717-721.
    • (2011) Science , vol.332 , Issue.MAY 6030 , pp. 717-721
    • Kim, B.H.1    Shenoy, A.R.2    Kumar, P.3    Das, R.4    Tiwari, S.5    MacMicking, J.D.6
  • 26
    • 79251547359 scopus 로고    scopus 로고
    • Interferon-gamma release assays for the diagnosis of latent Mycobacterium tuberculosis infection: a systematic review and meta-analysis
    • Diel R., Goletti D., Ferrara G., Bothamley G., Cirillo D., Kampmann B., et al. Interferon-gamma release assays for the diagnosis of latent Mycobacterium tuberculosis infection: a systematic review and meta-analysis. Eur Respir J 2011, 37(January (1)):88-99.
    • (2011) Eur Respir J , vol.37 , Issue.JANUARY 1 , pp. 88-99
    • Diel, R.1    Goletti, D.2    Ferrara, G.3    Bothamley, G.4    Cirillo, D.5    Kampmann, B.6
  • 27
    • 41149096579 scopus 로고    scopus 로고
    • T-cell quality in memory and protection: implications for vaccine design
    • Seder R.A., Darrah P.A., Roederer M. T-cell quality in memory and protection: implications for vaccine design. Nat Rev Immunol 2008, 8(April (4)):247-258.
    • (2008) Nat Rev Immunol , vol.8 , Issue.APRIL 4 , pp. 247-258
    • Seder, R.A.1    Darrah, P.A.2    Roederer, M.3
  • 28
    • 34250303350 scopus 로고    scopus 로고
    • Multifunctional TH1 cells define a correlate of vaccine-mediated protection against Leishmania major
    • Darrah P.A., Patel D.T., De Luca P.M., Lindsay R.W., Davey D.F., Flynn B.J., et al. Multifunctional TH1 cells define a correlate of vaccine-mediated protection against Leishmania major. Nat Med 2007, 13(July (7)):843-850.
    • (2007) Nat Med , vol.13 , Issue.JULY 7 , pp. 843-850
    • Darrah, P.A.1    Patel, D.T.2    De Luca, P.M.3    Lindsay, R.W.4    Davey, D.F.5    Flynn, B.J.6
  • 29
    • 34547773111 scopus 로고    scopus 로고
    • Multiple-cytokine-producing antiviral CD4 T cells are functionally superior to single-cytokine-producing cells
    • Kannanganat S., Ibegbu C., Chennareddi L., Robinson H.L., Amara R.R. Multiple-cytokine-producing antiviral CD4 T cells are functionally superior to single-cytokine-producing cells. J Virol 2007, 81(August (16)):8468-8476.
    • (2007) J Virol , vol.81 , Issue.AUGUST 16 , pp. 8468-8476
    • Kannanganat, S.1    Ibegbu, C.2    Chennareddi, L.3    Robinson, H.L.4    Amara, R.R.5
  • 30
    • 33646380363 scopus 로고    scopus 로고
    • Functional signatures in antiviral T-cell immunity for monitoring virus-associated diseases
    • Pantaleo G., Harari A. Functional signatures in antiviral T-cell immunity for monitoring virus-associated diseases. Nat Rev Immunol 2006, 6(May (5)):417-423.
    • (2006) Nat Rev Immunol , vol.6 , Issue.MAY 5 , pp. 417-423
    • Pantaleo, G.1    Harari, A.2
  • 31
    • 2142730100 scopus 로고    scopus 로고
    • Central memory and effector memory T cell subsets: function, generation, and maintenance
    • Sallusto F., Geginat J., Lanzavecchia A. Central memory and effector memory T cell subsets: function, generation, and maintenance. Annu Rev Immunol 2004, 22:745-763.
    • (2004) Annu Rev Immunol , vol.22 , pp. 745-763
    • Sallusto, F.1    Geginat, J.2    Lanzavecchia, A.3
  • 32
    • 67650932256 scopus 로고    scopus 로고
    • Cell-mediated immune responses in tuberculosis
    • Cooper A.M. Cell-mediated immune responses in tuberculosis. Annu Rev Immunol 2009, 27:393-422.
    • (2009) Annu Rev Immunol , vol.27 , pp. 393-422
    • Cooper, A.M.1
  • 33
    • 79951915895 scopus 로고    scopus 로고
    • Novel regulatory functions for Toll-like receptor-activated B cells during intracellular bacterial infection
    • Fillatreau S. Novel regulatory functions for Toll-like receptor-activated B cells during intracellular bacterial infection. Immunol Rev 2011, 240(March (1)):52-71.
    • (2011) Immunol Rev , vol.240 , Issue.MARCH 1 , pp. 52-71
    • Fillatreau, S.1
  • 34
    • 79953042689 scopus 로고    scopus 로고
    • Antibody-Fc receptor interactions in protection against intracellular pathogens
    • Joller N., Weber S.S., Oxenius A. Antibody-Fc receptor interactions in protection against intracellular pathogens. Eur J Immunol 2011, 41(April (4)):889-897.
    • (2011) Eur J Immunol , vol.41 , Issue.APRIL 4 , pp. 889-897
    • Joller, N.1    Weber, S.S.2    Oxenius, A.3
  • 35
    • 34249792654 scopus 로고    scopus 로고
    • B cells moderate inflammatory progression and enhance bacterial containment upon pulmonary challenge with Mycobacterium tuberculosis
    • Maglione P.J., Xu J., Chan J. B cells moderate inflammatory progression and enhance bacterial containment upon pulmonary challenge with Mycobacterium tuberculosis. J Immunol 2007, 178(June (11)):7222-7234.
    • (2007) J Immunol , vol.178 , Issue.JUNE 11 , pp. 7222-7234
    • Maglione, P.J.1    Xu, J.2    Chan, J.3
  • 36
    • 49149094065 scopus 로고    scopus 로고
    • Fc gamma receptors regulate immune activation and susceptibility during Mycobacterium tuberculosis infection
    • Maglione P.J., Xu J., Casadevall A., Chan J. Fc gamma receptors regulate immune activation and susceptibility during Mycobacterium tuberculosis infection. J Immunol 2008, 180(March (5)):3329-3338.
    • (2008) J Immunol , vol.180 , Issue.MARCH 5 , pp. 3329-3338
    • Maglione, P.J.1    Xu, J.2    Casadevall, A.3    Chan, J.4
  • 37
    • 79959242498 scopus 로고    scopus 로고
    • Detection of prokaryotic mRNA signifies microbial viability and promotes immunity
    • Sander L.E., Davis M.J., Boekschoten M.V., Amsen D., Dascher C.C., Ryffel B., et al. Detection of prokaryotic mRNA signifies microbial viability and promotes immunity. Nature 2011, 474(June (7351)):385-389.
    • (2011) Nature , vol.474 , Issue.JUNE 7351 , pp. 385-389
    • Sander, L.E.1    Davis, M.J.2    Boekschoten, M.V.3    Amsen, D.4    Dascher, C.C.5    Ryffel, B.6
  • 38
    • 84857546470 scopus 로고    scopus 로고
    • Beyond pattern recognition: five immune checkpoints for scaling the microbial threat
    • Blander J.M., Sander L.E. Beyond pattern recognition: five immune checkpoints for scaling the microbial threat. Nat Rev Immunol 2012, 12(March (3)):215-225.
    • (2012) Nat Rev Immunol , vol.12 , Issue.MARCH 3 , pp. 215-225
    • Blander, J.M.1    Sander, L.E.2
  • 39
    • 79551712276 scopus 로고    scopus 로고
    • Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period?
    • Aaby P., Roth A., Ravn H., Napirna B.M., Rodrigues A., Lisse I.M., et al. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period?. J Infect Dis 2011, 204(June (2)):245-252.
    • (2011) J Infect Dis , vol.204 , Issue.JUNE 2 , pp. 245-252
    • Aaby, P.1    Roth, A.2    Ravn, H.3    Napirna, B.M.4    Rodrigues, A.5    Lisse, I.M.6
  • 40
    • 33746681876 scopus 로고    scopus 로고
    • Bacillus Calmette-Guerin vaccination and infant mortality
    • Roth A., Garly M.L., Jensen H., Nielsen J., Aaby P. Bacillus Calmette-Guerin vaccination and infant mortality. Expert Rev Vaccines 2006, 5(April (2)):277-293.
    • (2006) Expert Rev Vaccines , vol.5 , Issue.APRIL 2 , pp. 277-293
    • Roth, A.1    Garly, M.L.2    Jensen, H.3    Nielsen, J.4    Aaby, P.5
  • 41
    • 0038043371 scopus 로고    scopus 로고
    • BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG?
    • Garly M.L., Martins C.L., Bale C., Balde M.A., Hedegaard K.L., Gustafson P., et al. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG?. Vaccine 2003, 21(June (21-22)):2782-2790.
    • (2003) Vaccine , vol.21 , Issue.JUNE 21 22 , pp. 2782-2790
    • Garly, M.L.1    Martins, C.L.2    Bale, C.3    Balde, M.A.4    Hedegaard, K.L.5    Gustafson, P.6
  • 42
    • 84869887217 scopus 로고    scopus 로고
    • Recombinant live vaccine candidates against tuberculosis
    • Kaufmann S.H., Gengenbacher M. Recombinant live vaccine candidates against tuberculosis. Curr Opin Biotechnol 2012, 23(April):900-907.
    • (2012) Curr Opin Biotechnol , vol.23 , Issue.APRIL , pp. 900-907
    • Kaufmann, S.H.1    Gengenbacher, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.