Display options
Cite
Trombetta CM, Perini D, Mather S, et al. Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future. Vaccines (Basel). 2014;2(4):707-34doi: 10.3390/vaccines2040707.
Trombetta, C. M., Perini, D., Mather, S., Temperton, N., & Montomoli, E. (2014). Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future. Vaccines, 2(4), 707-34. https://doi.org/10.3390/vaccines2040707
Trombetta, Claudia Maria, et al. "Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future." Vaccines vol. 2,4 (2014): 707-34. doi: https://doi.org/10.3390/vaccines2040707
Trombetta CM, Perini D, Mather S, Temperton N, Montomoli E. Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future. Vaccines (Basel). 2014 Oct 13;2(4):707-34. doi: 10.3390/vaccines2040707. PMID: 26344888; PMCID: PMC4494249.
Copy Download .nbib Format: NLM
Share it on

Vaccines (Basel). 2014 Oct 13;2(4):707-34. doi: 10.3390/vaccines2040707.

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future.

Vaccines

Claudia Maria Trombetta, Daniele Perini, Stuart Mather, Nigel Temperton, Emanuele Montomoli

Affiliations

  1. Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy. [email protected].
  2. VisMederi srl, Enterprise in Life Sciences, Via Fiorentina 1, 53100 Siena, Italy. [email protected].
  3. Viral Pseudotype Unit, School of Pharmacy, University of Kent, Chatham Maritime, Kent ME4 4TB, UK. [email protected].
  4. Viral Pseudotype Unit, School of Pharmacy, University of Kent, Chatham Maritime, Kent ME4 4TB, UK. [email protected].
  5. Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy. [email protected].
  6. VisMederi srl, Enterprise in Life Sciences, Via Fiorentina 1, 53100 Siena, Italy. [email protected].

PMID: 26344888 PMCID: PMC4494249 DOI: 10.3390/vaccines2040707

Abstract

Serological techniques commonly used to quantify influenza-specific antibodies include the Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Virus Neutralization (VN) assays. HI and SRH are established and reproducible techniques, whereas VN is more demanding. Every new influenza vaccine needs to fulfil the strict criteria issued by the European Medicines Agency (EMA) in order to be licensed. These criteria currently apply exclusively to SRH and HI assays and refer to two different target groups-healthy adults and the elderly, but other vaccine recipient age groups have not been considered (i.e., children). The purpose of this timely review is to highlight the current scenario on correlates of protection concerning influenza vaccines and underline the need to revise the criteria and assays currently in use. In addition to SRH and HI assays, the technical advantages provided by other techniques such as the VN assay, pseudotype-based neutralization assay, neuraminidase and cell-mediated immunity assays need to be considered and regulated via EMA criteria, considering the many significant advantages that they could offer for the development of effective vaccines.

Keywords: EMA criteria; antibody titres; correlates of protection

References

  1. J Clin Microbiol. 1990 Jun;28(6):1308-13 - PubMed
  2. J Gen Virol. 1968 Dec;3(3):315-26 - PubMed
  3. J Clin Microbiol. 1979 Sep;10(3):382-4 - PubMed
  4. Vaccine. 2011 Oct 6;29(43):7572-5 - PubMed
  5. Biomed Pharmacother. 2000 May;54(4):188-95 - PubMed
  6. PLoS One. 2011 Apr 01;6(4):e17665 - PubMed
  7. Biologicals. 2009 Aug;37(4):216-21 - PubMed
  8. Clin Infect Dis. 2012 Jun;54(11):1615-7 - PubMed
  9. Vaccine. 2012 Jan 5;30(2):329-35 - PubMed
  10. Hum Vaccin Immunother. 2013 May;9(5):977-86 - PubMed
  11. Pediatr Infect Dis J. 2011 Dec;30(12):1081-5 - PubMed
  12. Vaccine. 2011 Oct 19;29(45):8049-59 - PubMed
  13. Vaccine. 2009 Oct 9;27(43):5998-6003 - PubMed
  14. J Clin Microbiol. 1988 Feb;26(2):333-7 - PubMed
  15. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82 - PubMed
  16. Hum Vaccin Immunother. 2012 Jan;8(1):34-44 - PubMed
  17. J Virol. 1968 Apr;2(4):281-8 - PubMed
  18. Nat Med. 2012 Jan 29;18(2):274-80 - PubMed
  19. Clin Vaccine Immunol. 2012 Jul;19(7):1012-8 - PubMed
  20. J Infect Dis. 1974 Apr;129(4):411-20 - PubMed
  21. Front Immunol. 2011 Dec 16;2:76 - PubMed
  22. Bull World Health Organ. 1975;52(1):43-50 - PubMed
  23. Science. 2011 Aug 12;333(6044):850-6 - PubMed
  24. J Clin Invest. 2010 May;120(5):1663-73 - PubMed
  25. Lancet. 2001 Jun 16;357(9272):1937-43 - PubMed
  26. Vaccine. 1998 May-Jun;16(9-10):1009-15 - PubMed
  27. J Hyg (Lond). 1983 Aug;91(1):157-62 - PubMed
  28. Clin Diagn Lab Immunol. 2004 Mar;11(2):406-10 - PubMed
  29. Vaccine. 2012 Sep 21;30(43):6127-35 - PubMed
  30. Exp Gerontol. 2002 Jan-Mar;37(2-3):427-39 - PubMed
  31. Clin Infect Dis. 2008 Aug 1;47(3):401-9 - PubMed
  32. Pediatrics. 2010 Oct;126(4):e762-70 - PubMed
  33. Nat Biotechnol. 2007 Dec;25(12):1361-6 - PubMed
  34. Clin Vaccine Immunol. 2010 Jul;17(7):1055-65 - PubMed
  35. J Clin Virol. 2008 Sep;43(1):73-8 - PubMed
  36. Clin Immunol. 2011 Nov;141(2):161-8 - PubMed
  37. Vaccine. 2000 Dec 8;19(9-10):1180-7 - PubMed
  38. J Clin Virol. 2011 Dec;52(4):300-3 - PubMed
  39. J Immunol. 2013 Feb 15;190(4):1837-48 - PubMed
  40. Vaccine. 2010 Jan 8;28(3):790-7 - PubMed
  41. Vaccine. 1995 Dec;13(18):1799-803 - PubMed
  42. Philos Trans R Soc Lond B Biol Sci. 2001 Dec 29;356(1416):1861-70 - PubMed
  43. Am J Med. 2008 Apr;121(4):258-64 - PubMed
  44. Med Microbiol Immunol. 2010 May;199(2):117-21 - PubMed
  45. Clin Vaccine Immunol. 2006 Sep;13(9):981-90 - PubMed
  46. Expert Rev Anti Infect Ther. 2011 Apr;9(4):443-55 - PubMed
  47. J Clin Microbiol. 2011 Jun;49(6):2210-5 - PubMed
  48. J Hyg (Lond). 1982 Apr;88(2):325-33 - PubMed
  49. Vaccine. 2012 Feb 8;30(7):1388-96 - PubMed
  50. Vaccine. 2003 May 1;21(16):1780-5 - PubMed
  51. J Hyg (Lond). 1983 Aug;91(1):131-8 - PubMed
  52. PLoS Pathog. 2013 Mar;9(3):e1003207 - PubMed
  53. J Virol. 1968 Aug;2(8):778-86 - PubMed
  54. J Virol Methods. 2011 May;173(2):364-73 - PubMed
  55. J Clin Microbiol. 1999 Apr;37(4):937-43 - PubMed
  56. Dev Biol (Basel). 2003;115:63-73 - PubMed
  57. BMC Med Res Methodol. 2010 Mar 08;10:18 - PubMed
  58. J Clin Microbiol. 1975 Sep;2(3):157-61 - PubMed
  59. AAPS J. 2010 Jun;12(2):215-22 - PubMed
  60. Vaccine. 1994 Feb;12(2):167-74 - PubMed
  61. J Virol. 2013 Mar;87(6):3053-61 - PubMed
  62. J Virol. 1989 Mar;63(3):1239-46 - PubMed
  63. J Mol Genet Med. 2012;6:304-8 - PubMed
  64. Virology. 2005 Sep 1;339(2):273-80 - PubMed
  65. Vet Microbiol. 1995 Jun;45(1):81-92 - PubMed
  66. Influenza Res Treat. 2013;2013:286158 - PubMed
  67. J Clin Microbiol. 1980 Sep;12(3):426-32 - PubMed
  68. Vaccine. 2007 May 16;25(20):4056-63 - PubMed
  69. J Med Virol. 2004 Sep;74(1):141-6 - PubMed
  70. Vaccine. 2012 Mar 28;30(15):2516-22 - PubMed
  71. J Hyg (Lond). 1977 Dec;79(3):355-64 - PubMed
  72. Scand J Immunol. 2004 Jan;59(1):1-15 - PubMed
  73. PLoS One. 2009 Nov 20;4(11):e7918 - PubMed
  74. Proc Natl Acad Sci U S A. 2011 Dec 20;108(51):20748-53 - PubMed
  75. Science. 2000 Feb 4;287(5454):860-4 - PubMed
  76. J Infect Dis. 2007 Nov 1;196(9):1304-12 - PubMed
  77. PLoS One. 2011;6(8):e23791 - PubMed
  78. Proc Natl Acad Sci U S A. 1990 Jan;87(2):786-90 - PubMed
  79. Lancet. 2011 Feb 26;377(9767):751-9 - PubMed
  80. J Virol. 2010 Oct;84(19):10366-74 - PubMed
  81. J Biol Chem. 2010 Sep 10;285(37):28403-9 - PubMed
  82. N Engl J Med. 2008 Jun 12;358(24):2573-84 - PubMed
  83. Emerg Infect Dis. 2006 Jan;12(1):55-60 - PubMed
  84. Pharmacol Ther. 2008 Nov;120(2):186-96 - PubMed
  85. J Clin Microbiol. 1984 Aug;20(2):248-54 - PubMed
  86. Virus Res. 2004 Jul;103(1-2):133-8 - PubMed
  87. Lancet. 2010 Mar 27;375(9720):1100-8 - PubMed
  88. Clin Vaccine Immunol. 2009 Apr;16(4):558-66 - PubMed
  89. Recenti Prog Med. 2000 Dec;91(12):657-66 - PubMed
  90. J Immunol. 1987 Sep 15;139(6):2010-4 - PubMed
  91. MMWR Recomm Rep. 2005 Jul 29;54(RR-8):1-40 - PubMed
  92. Vaccine. 2012 Jan 20;30(5):879-85 - PubMed
  93. Biologicals. 2010 Sep;38(5):544-51 - PubMed
  94. Bull World Health Organ. 1969;41(3):647-50 - PubMed
  95. J Virol. 2012 May;86(10):5774-81 - PubMed
  96. J Infect Dis. 2007 Nov 1;196(9):1279-81 - PubMed
  97. Infect Immun. 1976 Jan;13(1):1-8 - PubMed
  98. J Virol. 2006 Oct;80(19):9896-8 - PubMed
  99. Arch Virol. 1976;52(1-2):91-9 - PubMed
  100. Ann N Y Acad Sci. 2011 Jan;1217:178-90 - PubMed
  101. PLoS Med. 2007 Feb;4(2):e59 - PubMed
  102. Virology. 2012 Oct 10;432(1):39-44 - PubMed
  103. J Immunol Methods. 1990 Dec 31;135(1-2):49-57 - PubMed
  104. Immunol Rev. 2011 Jan;239(1):167-77 - PubMed
  105. J Infect Dis. 2013 Oct 15;208(8):1320-4 - PubMed
  106. J Clin Virol. 2010 Jan;47(1):29-33 - PubMed
  107. Emerg Infect Dis. 2006 Jan;12(1):48-54 - PubMed
  108. Infect Immun. 1980 Sep;29(3):966-71 - PubMed
  109. Bull World Health Organ. 1985;63(6):1043-53 - PubMed
  110. Vaccine. 2012 Dec 17;31(1):190-5 - PubMed
  111. Proc Natl Acad Sci U S A. 1985 Mar;82(6):1785-9 - PubMed
  112. Epidemiol Rev. 1996;18(2):99-117 - PubMed
  113. J Hyg (Lond). 1984 Oct;93(2):301-12 - PubMed
  114. Nat Struct Mol Biol. 2009 Mar;16(3):265-73 - PubMed
  115. J Clin Microbiol. 1977 Mar;5(3):353-60 - PubMed
  116. Biomed Res Int. 2014;2014:231365 - PubMed
  117. N Engl J Med. 2009 Nov 12;361(20):1945-52 - PubMed
  118. J Gen Virol. 1975 Apr;27(1):1-10 - PubMed
  119. J Gen Virol. 2000 Nov;81(Pt 11):2689-96 - PubMed
  120. J Infect Dis. 2011 Jan 15;203(2):158-67 - PubMed
  121. J Virol Methods. 2008 Oct;153(1):43-8 - PubMed
  122. J Virol Methods. 2008 Nov;153(2):111-9 - PubMed
  123. Lancet. 1973 Mar 24;1(7804):623-5 - PubMed
  124. Vaccine. 2002 Jan 31;20(9-10):1340-53 - PubMed
  125. Clin Diagn Lab Immunol. 1996 Sep;3(5):511-6 - PubMed
  126. Vaccine. 2010 Nov 16;28(49):7716-22 - PubMed
  127. Emerg Infect Dis. 2009 Aug;15(8):1252-9 - PubMed
  128. Proc Natl Acad Sci U S A. 2014 Jun 24;111(25):E2514-23 - PubMed
  129. Influenza Other Respir Viruses. 2009 Nov;3(6):315-25 - PubMed
  130. Stat Med. 1999 Aug 30;18(16):2101-9 - PubMed
  131. J Infect Dis. 2012 Jan 1;205(1):28-34 - PubMed
  132. Vaccine. 2003 Apr 2;21(15):1687-93 - PubMed
  133. Am J Epidemiol. 1982 Aug;116(2):228-42 - PubMed
  134. J Mol Genet Med. 2012;7:309-14 - PubMed
  135. Immunol Lett. 2011 Mar 30;135(1-2):59-63 - PubMed
  136. J Clin Microbiol. 1977 Jun;5(6):613-20 - PubMed
  137. Expert Rev Vaccines. 2011 Aug;10(8):1127-30 - PubMed
  138. Vaccine. 2007 May 10;25(19):3763-72 - PubMed
  139. Influenza Other Respir Viruses. 2007 May;1(3):105-12 - PubMed
  140. J Hyg (Lond). 1972 Dec;70(4):767-77 - PubMed
  141. Vaccine. 2002 Aug 19;20(25-26):3068-87 - PubMed
  142. Clin Ther. 2010 Dec;32(13):2186-97 - PubMed
  143. Vaccine. 2014 Apr 17;32(19):2225-30 - PubMed
  144. J Hyg (Lond). 1978 Feb;80(1):1-11 - PubMed
  145. Stat Med. 2006 May 15;25(9):1485-97 - PubMed
  146. Expert Rev Vaccines. 2009 Apr;8(4):401-23 - PubMed
  147. J Immunol Res. 2014;2014:457932 - PubMed
  148. J Clin Pathol. 1978 Jun;31(6):521-6 - PubMed
  149. Curr Top Microbiol Immunol. 2009;333:227-41 - PubMed
  150. Clin Infect Dis. 2009 Apr 15;48(8):1087-95 - PubMed
  151. Virus Res. 2004 Jul;103(1-2):91-5 - PubMed

Publication Types