Serum bactericidal antibody assays - The role of complement in infection and immunity

被引:69
作者
McIntosh, E. D. G. [1 ]
Broeker, M. [2 ]
Wassil, J. [3 ]
Welsch, J. A. [3 ]
Borrow, R. [4 ]
机构
[1] Univ London Imperial Coll Sci Technol & Med, London SW7 2AZ, England
[2] Novartis Vaccines GmbH, Marburg, Germany
[3] GSK Vaccines Inc, Cambridge, MA USA
[4] Manchester Royal Infirm, Publ Hlth England, Vaccine Evaluat Unit, Manchester M13 9WL, Lancs, England
关键词
Complement; Serum bactericidal antibody; Meningococcal infection; Meningococcal vaccine; FACTOR-H-BINDING; INFLUENZAE TYPE-B; NEISSERIA-MENINGITIDIS SEROGROUP; TOXOID CONJUGATE VACCINE; MENINGOCOCCAL GLYCOCONJUGATE VACCINE; MEMBRANE VESICLE VACCINES; BIVALENT RLP2086 VACCINE; PHASE; 1/2; TRIAL; HAEMOPHILUS-INFLUENZAE; INVESTIGATIONAL MULTICOMPONENT;
D O I
10.1016/j.vaccine.2015.07.019
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Complement is an essential component of the immune system and human pathogenic organisms have developed various mechanisms for evading complement mediated serum killing. The "gold standard" for measuring the ability of vaccine-induced antibody to kill Neisseria meningitidis is the serum bactericidal antibody (SBA) assay which measures complement mediated killing via antibody. This assay requires active complement, either intrinsic from the serum being tested or the addition of exogenous complement, either from a human or from another species such as rabbit. For serogroup C, an SBA titre of >= 4 was established as the correlate of protection when using human complement and >= 8 as the threshold when using rabbit complement, based on comparative assay results. Licensure of meningococcal vaccines, including polysaccharide protein conjugate vaccines and serogroup B vaccines has been based on the immune responses measured with the SBA assay, thus on a surrogate of vaccine efficacy. This review examines the use of complement and the SBA assay to assess immunity to meningococcal infection, and provides examples of vaccine trials in different age groups where various assays have been used. (C) 2015 Elsevier Ltd. All rights reserved.
引用
收藏
页码:4414 / 4421
页数:8
相关论文
共 95 条
[1]   Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England [J].
Andrews, N ;
Borrow, R ;
Miller, E .
CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 2003, 10 (05) :780-786
[2]  
[Anonymous], 1976, WHO Technical Report Series, V594, P72
[3]   Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines [J].
Arguedas, A. ;
Soley, C. ;
Loaiza, C. ;
Rincon, G. ;
Guevara, S. ;
Perez, A. ;
Porras, W. ;
Alvarado, O. ;
Aguilar, L. ;
Abdelnour, A. ;
Grunwald, U. ;
Bedell, L. ;
Anemona, A. ;
Dull, P. M. .
VACCINE, 2010, 28 (18) :3171-3179
[4]  
Bai X, 2014, 19 INT PATH NEISS C
[5]   Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age [J].
Baxter, Roger ;
Baine, Yaela ;
Ensor, Kathleen ;
Bianco, Veronique ;
Friedland, Leonard R. ;
Miller, Jacqueline M. .
PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2011, 30 (03) :E41-E48
[6]   Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults [J].
Bermal, Nancy ;
Huang, Li-Min ;
Dubey, A. P. ;
Jain, Hermant ;
Bavdekar, Ashish ;
Lin, Tzou-Yien ;
Bianco, Veronique ;
Baine, Yaela ;
Miller, Jacqueline M. .
HUMAN VACCINES, 2011, 7 (02) :239-247
[7]   Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age [J].
Black, S. ;
Klein, N. P. ;
Shah, J. ;
Bedell, L. ;
Karsten, A. ;
Dull, P. M. .
VACCINE, 2010, 28 (03) :657-663
[8]   Three-year Antibody Persistence and Safety After a Single Dose of Combined Haemophilus influenzae Type b (Hib)-Neisseria meningitidis Serogroup C-tetanus Toxoid Conjugate Vaccine in Hib-primed Toddlers [J].
Booy, Robert ;
Richmond, Peter ;
Nolan, Terry ;
McVernon, Jodie ;
Marshall, Helen ;
Nissen, Michael ;
Reynolds, Graham ;
Ziegler, John B. ;
Stoney, Tanya ;
Heron, Leon ;
Lambert, Stephen ;
Mesaros, Narcisa ;
Peddiraju, Kavitha ;
Miller, Jacqueline M. .
PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2013, 32 (02) :169-174
[9]   Neisseria meningitidis group B correlates of protection and assay standardization -: International meeting report Emory University, Atlanta, Georgia, United States, 16-17 march 2005 [J].
Borrow, R. ;
Carlone, G. M. ;
Rosenstein, N. ;
Plikaytis, B. ;
Blake, M. ;
Feavers, I. ;
Martin, D. ;
Zollinger, W. ;
Robbins, J. ;
Aaberge, I. ;
Granoff, D. M. ;
Miller, E. ;
van Alphen, L. ;
Poolman, J. ;
Rappuoli, R. ;
Danzig, L. ;
Hackell, J. ;
Danve, B. ;
Caulfield, M. ;
Lambert, S. ;
Stephens, D. .
VACCINE, 2006, 24 (24) :5093-5107
[10]   Meningococcal surrogates of protection - serum bactericidal antibody activity [J].
Borrow, R ;
Balmer, P ;
Miller, E .
VACCINE, 2005, 23 (17-18) :2222-2227