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

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

Claudia Maria Trombetta  1 , Daniele Perini  2 , Stuart Mather  3 , Nigel Temperton  4 , Emanuele Montomoli  5   6
Affiliations
Review

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

Claudia Maria Trombetta et al. Vaccines (Basel). .

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.

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Figures

Figure 1
Figure 1
Correlation between antibody titres measured by VN and HI assays using sera from 87 confirmed cases of 2009 H1N1 virus. The results show a strong positive correlation between the two assay titres [52].
Figure 2
Figure 2
Relationship between HI and neutralizing antibody titres against A/Yamagata/12/86 (H1N1), A/Fukuoka/C29/85 (H3N2) and A/Shisen/2/87 (H3N2) [65].
Figure 3
Figure 3
Representation of the production and assay of influenza HA pseudotyped retroviruses [72].
Figure 4
Figure 4
Antibody titres measured by HI, VN and SRH assays after a vaccination with a non-adjuvanted vaccine or an MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine. At each visit, the HI assay was shown to underestimate antibody responses when compared to VN and SRH assays [106].
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