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Volumn 30, Issue 27, 2012, Pages 4113-4122

Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines-An effective EU regulatory approach

Author keywords

Haemagglutination inhibition; Neutralisation; Pandemic influenza; Regulatory assessment; Serological assays; Vaccine immunogenicity

Indexed keywords

INFLUENZA VACCINE;

EID: 84861482095     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.02.077     Document Type: Article
Times cited : (26)

References (31)
  • 1
    • 49549112108 scopus 로고    scopus 로고
    • Laboratory diagnosis of influenza
    • Blackwell publishing, Oxford (UK), K.G. Nicholson, R.G. Webster, A.J. Hay (Eds.)
    • Zambon M.C. Laboratory diagnosis of influenza. Influenza 1997, 123-156. Blackwell publishing, Oxford (UK). K.G. Nicholson, R.G. Webster, A.J. Hay (Eds.).
    • (1997) Influenza , pp. 123-156
    • Zambon, M.C.1
  • 2
    • 3342983070 scopus 로고    scopus 로고
    • Available from:, [accessed 31.01.2012], World Health Organisation Global influenza programme [Internet]
    • World Health Organisation Global influenza programme [Internet] WHO manual on animal influenza diagnosis and surveillance 2002, Available from:, [accessed 31.01.2012]. http://www.who.int/csr/resources/publications/influenza/whocdscsrncs20025rev.pdf.
    • (2002) WHO manual on animal influenza diagnosis and surveillance
  • 3
    • 0012016360 scopus 로고    scopus 로고
    • Available from:, [accessed 31.01.2012], Committee for proprietary medicinal products of the European Medicines Agency (EMA) [Internet]
    • Committee for proprietary medicinal products of the European Medicines Agency (EMA) [Internet] Note for guidance on harmonization of requirements for influenza vaccines, CPMP/BWP/214/96 (12 March 1997) 1997, Available from:, [accessed 31.01.2012]. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf.
    • (1997) Note for guidance on harmonization of requirements for influenza vaccines, CPMP/BWP/214/96 (12 March 1997)
  • 5
    • 0015452705 scopus 로고
    • The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses
    • Hobson D., Curry R.L., Beare A.S., Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg 1972, 70:767-777.
    • (1972) J Hyg , vol.70 , pp. 767-777
    • Hobson, D.1    Curry, R.L.2    Beare, A.S.3    Ward-Gardner, A.4
  • 6
    • 16544382028 scopus 로고    scopus 로고
    • The use of correlates of immunity in European Union licensing of influenza vaccines
    • Dev. Biol. Karger, Basel
    • Wood J.M., Newman R.W., Ploss K. The use of correlates of immunity in European Union licensing of influenza vaccines. Laboratory correlates of immunity to influenza-a reassessment 2003, 115:9-16. Dev. Biol. Karger, Basel.
    • (2003) Laboratory correlates of immunity to influenza-a reassessment , vol.115 , pp. 9-16
    • Wood, J.M.1    Newman, R.W.2    Ploss, K.3
  • 7
    • 0033041241 scopus 로고    scopus 로고
    • Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays
    • Rowe T., Abernathy R.A., Hu-Primmer J., Thompson W.W., Lu X., Lim W., et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999, 37:937-943.
    • (1999) J Clin Microbiol , vol.37 , pp. 937-943
    • Rowe, T.1    Abernathy, R.A.2    Hu-Primmer, J.3    Thompson, W.W.4    Lu, X.5    Lim, W.6
  • 8
    • 0031579234 scopus 로고    scopus 로고
    • Receptor specificity of influenza A viruses correlates with the agglutination of erythrocytes from different animal species
    • Ito T., Suzuki Y., Mitnaul L., Vines A., Kida H., Kawaoka Y. Receptor specificity of influenza A viruses correlates with the agglutination of erythrocytes from different animal species. Virology 1997, 227:493-499.
    • (1997) Virology , vol.227 , pp. 493-499
    • Ito, T.1    Suzuki, Y.2    Mitnaul, L.3    Vines, A.4    Kida, H.5    Kawaoka, Y.6
  • 9
    • 0038024223 scopus 로고    scopus 로고
    • Sialic acid receptor specificity on erythrocytes affects detection of antibody to avian influenza haemagglutinin
    • Stephenson I., Wood J.M., Nicholson K.G., Zambon M.C. Sialic acid receptor specificity on erythrocytes affects detection of antibody to avian influenza haemagglutinin. J Med Virol 2003, 70:391-398.
    • (2003) J Med Virol , vol.70 , pp. 391-398
    • Stephenson, I.1    Wood, J.M.2    Nicholson, K.G.3    Zambon, M.C.4
  • 10
    • 49949090082 scopus 로고    scopus 로고
    • Testing human sera for antibodies against avian influenza viruses: horse RBC hemagglutination inhibition vs. microneutralization assays
    • Kayali G., Setterquist S.F., Capuano A.W., Myers K.P., Gill J.S., Gray G.C. Testing human sera for antibodies against avian influenza viruses: horse RBC hemagglutination inhibition vs. microneutralization assays. J Clin Virol 2008, 43:73-78.
    • (2008) J Clin Virol , vol.43 , pp. 73-78
    • Kayali, G.1    Setterquist, S.F.2    Capuano, A.W.3    Myers, K.P.4    Gill, J.S.5    Gray, G.C.6
  • 11
    • 2442599892 scopus 로고    scopus 로고
    • Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine
    • Stephenson I., Wood J.M., Nicholson K.G., Charlett A., Zambon M.C. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine. Virus Res 2004, 103:91-95.
    • (2004) Virus Res , vol.103 , pp. 91-95
    • Stephenson, I.1    Wood, J.M.2    Nicholson, K.G.3    Charlett, A.4    Zambon, M.C.5
  • 13
    • 34247275658 scopus 로고    scopus 로고
    • Comparison of neutralising antibody assays for detection of antibody to influenza A/H3N2 viruses: an international collaborative study
    • Stephenson I., Das R.G., Wood J.M., Katz J.M. Comparison of neutralising antibody assays for detection of antibody to influenza A/H3N2 viruses: an international collaborative study. Vaccine 2007, 25:4056-4063.
    • (2007) Vaccine , vol.25 , pp. 4056-4063
    • Stephenson, I.1    Das, R.G.2    Wood, J.M.3    Katz, J.M.4
  • 16
    • 80052353535 scopus 로고    scopus 로고
    • Collaborative study on influenza vaccine clinical trial serology. Part 1. CHMP compliance study
    • Wood J.M., Newman R.W., Daas A., Terao E., Buchheit K.H. Collaborative study on influenza vaccine clinical trial serology. Part 1. CHMP compliance study. Pharmeur Bio Sci Notes 2011, 1:27-35.
    • (2011) Pharmeur Bio Sci Notes , vol.1 , pp. 27-35
    • Wood, J.M.1    Newman, R.W.2    Daas, A.3    Terao, E.4    Buchheit, K.H.5
  • 18
    • 84355162724 scopus 로고    scopus 로고
    • Reproducibility of serology assays for pandemic influenza H1N1: collaborative study to evaluate a candidate WHO International Standard
    • Wood J.M., Major D., Heath A., Newman R.W., Höschler K., Stephenson I., et al. Reproducibility of serology assays for pandemic influenza H1N1: collaborative study to evaluate a candidate WHO International Standard. Vaccine 2012, 30:210-217.
    • (2012) Vaccine , vol.30 , pp. 210-217
    • Wood, J.M.1    Major, D.2    Heath, A.3    Newman, R.W.4    Höschler, K.5    Stephenson, I.6
  • 19
    • 84873062439 scopus 로고    scopus 로고
    • Available from:, [accessed 31.01.2012]., National Institute for Biological Standards and Control (NIBSC) [Internet]
    • National Institute for Biological Standards and Control (NIBSC) [Internet] Biological Reference Materials 2012, Available from:, [accessed 31.01.2012]. http://www.nibsc.ac.uk/products/biological_reference_materials.aspx.
    • (2012) Biological Reference Materials
  • 21
    • 0028044778 scopus 로고
    • Comparison of influenza serological techniques by international collaborative study
    • Wood J.M., Gaines-Das R.E., Taylor J., Chakraverty P. Comparison of influenza serological techniques by international collaborative study. Vaccine 1994, 12:167-174.
    • (1994) Vaccine , vol.12 , pp. 167-174
    • Wood, J.M.1    Gaines-Das, R.E.2    Taylor, J.3    Chakraverty, P.4
  • 22
    • 0034257192 scopus 로고    scopus 로고
    • Cross-protection against a lethal influenza virus infection by DNA vaccine to neuraminidase
    • Chen Z., Kadowaki S., Hagiwara Y., Yoshikawa T., Matsuo K., Kurata T., et al. Cross-protection against a lethal influenza virus infection by DNA vaccine to neuraminidase. Vaccine 2000, 18:3214-3222.
    • (2000) Vaccine , vol.18 , pp. 3214-3222
    • Chen, Z.1    Kadowaki, S.2    Hagiwara, Y.3    Yoshikawa, T.4    Matsuo, K.5    Kurata, T.6
  • 23
    • 0016366813 scopus 로고
    • Induction of partial immunity to influenza by a neuraminidase-specific vaccine
    • Couch R.B., Kasel J.A., Gerin J.L., Schulman J.L., Kilbourne E.D. Induction of partial immunity to influenza by a neuraminidase-specific vaccine. J Infect Dis 1974, 129:411-420.
    • (1974) J Infect Dis , vol.129 , pp. 411-420
    • Couch, R.B.1    Kasel, J.A.2    Gerin, J.L.3    Schulman, J.L.4    Kilbourne, E.D.5
  • 24
    • 33847648935 scopus 로고    scopus 로고
    • Can immunity induced by the human influenza virus N1 neuraminidase provide some protection from avian influenza H5N1 viruses?
    • Gillim-Ross L., Subbarao K. Can immunity induced by the human influenza virus N1 neuraminidase provide some protection from avian influenza H5N1 viruses?. PLoS Med 2007, 4:e91.
    • (2007) PLoS Med , vol.4
    • Gillim-Ross, L.1    Subbarao, K.2
  • 25
    • 0024573756 scopus 로고
    • Purified influenza virus hemagglutinin and neuraminidase are equivalent in stimulation of antibody response but induce contrasting types of immunity to infection
    • Johansson B.E., Bucher D.J., Kilbourne E.D. Purified influenza virus hemagglutinin and neuraminidase are equivalent in stimulation of antibody response but induce contrasting types of immunity to infection. J Virol 1989, 63:1239-1246.
    • (1989) J Virol , vol.63 , pp. 1239-1246
    • Johansson, B.E.1    Bucher, D.J.2    Kilbourne, E.D.3
  • 26
    • 0032077894 scopus 로고    scopus 로고
    • Supplementation of conventional influenza A vaccine with purified viral neuraminidase results in a balanced and broadened immune response
    • Johansson B.E., Matthews J.T., Kilbourne E.D. Supplementation of conventional influenza A vaccine with purified viral neuraminidase results in a balanced and broadened immune response. Vaccine 1998, 16:1009-1015.
    • (1998) Vaccine , vol.16 , pp. 1009-1015
    • Johansson, B.E.1    Matthews, J.T.2    Kilbourne, E.D.3
  • 27
    • 0029793358 scopus 로고    scopus 로고
    • Neuraminidase-specific antibody responses to inactivated influenza virus vaccine in young and elderly adults
    • Powers D.C., Kilbourne E.D., Johansson B.E. Neuraminidase-specific antibody responses to inactivated influenza virus vaccine in young and elderly adults. Clin Diagn Lab Immunol 1996, 3:511-516.
    • (1996) Clin Diagn Lab Immunol , vol.3 , pp. 511-516
    • Powers, D.C.1    Kilbourne, E.D.2    Johansson, B.E.3
  • 28
    • 51449110453 scopus 로고    scopus 로고
    • Correlates of protection: novel generations of influenza vaccines
    • Rimmelzwaan G.F., McElhaney J.E. Correlates of protection: novel generations of influenza vaccines. Vaccine 2008, 26(Suppl. 4):D41-D44.
    • (2008) Vaccine , vol.26 , Issue.SUPPL. 4
    • Rimmelzwaan, G.F.1    McElhaney, J.E.2
  • 29
    • 34547776050 scopus 로고    scopus 로고
    • Orthomyxoviruses
    • Lippincott Williams & Wilkins, Philadelphia, D.M. Knipe, P.M. Howley, M. Peter, D.E. Griffin (Eds.)
    • Wright P.F., Neumann G., Kawaoka Y. Orthomyxoviruses. Fields Virology 2007, Lippincott Williams & Wilkins, Philadelphia, p. 1691-740. 5th ed. D.M. Knipe, P.M. Howley, M. Peter, D.E. Griffin (Eds.).
    • (2007) Fields Virology , pp. 1691-740
    • Wright, P.F.1    Neumann, G.2    Kawaoka, Y.3
  • 30
    • 0036090557 scopus 로고    scopus 로고
    • Functional balance between haemagglutinin and neuraminidase in influenza virus infections
    • Wagner R., Matrosovich M., Klenk H.D. Functional balance between haemagglutinin and neuraminidase in influenza virus infections. Rev Med Virol 2002, 12:159-166.
    • (2002) Rev Med Virol , vol.12 , pp. 159-166
    • Wagner, R.1    Matrosovich, M.2    Klenk, H.D.3
  • 31
    • 0016659425 scopus 로고
    • A single radial haemolysis technique for the measurement of influenza antibody
    • Russell S.M., McCahon D., Beare A.S. A single radial haemolysis technique for the measurement of influenza antibody. J Gen Virol 1975, 27:1-10.
    • (1975) J Gen Virol , vol.27 , pp. 1-10
    • Russell, S.M.1    McCahon, D.2    Beare, A.S.3


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