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. 2013;8(2):e56844.
doi: 10.1371/journal.pone.0056844. Epub 2013 Feb 22.

Comparing the immunogenicity of AS03-adjuvanted 2009 pandemic H1N1 vaccine with clinical protection in priority risk groups in England

Chee-Fu Yung  1 , Nick Andrews, Katja Hoschler, Elizabeth Miller
Affiliations

Comparing the immunogenicity of AS03-adjuvanted 2009 pandemic H1N1 vaccine with clinical protection in priority risk groups in England

Chee-Fu Yung et al. PLoS One. 2013.

Abstract

In England, during pandemic 2009 H1N1, vaccine efficacy and immunogenicity population studies in priority groups were rolled out in parallel to evaluate the pandemic vaccination programme. This provided a unique opportunity to compare immunogenicity and clinical protection in the same population and thus provide insights into the correlates of protection for the pandemic H1N1 2009 vaccine in risk groups. While clinical protection from AS03-adjuvanted pandemic 2009 H1N1 vaccine was high in those aged <25 years and pregnant women, effectiveness in older adults with chronic conditions has been found to be surprisingly poor. Here we present results from the immunogenicity study derived from the same population. Individuals from priority groups eligible for pandemic vaccination attending participating general practices were recruited. Pre and post-vaccination blood samples were collected and HI antibody testing to assess immune response to vaccination performed. The final cohort consisted of 610 individuals: 60 healthy children aged <5 years; 32 healthy pregnant women; 518 individuals from risk groups. Seroconversion rate in healthy children aged <5 years (87%, 95% CI: 75% to 94%) was higher than that of risk groups combined (65%, 95% CI: 61% to 69%) (p<0.001). Multivariable analysis of risk groups showed that the size of response in those who did seroconvert was lower in those who received the 2009/10 seasonal TIV (Fold effect: 0.52, 0.35 to 0.78). Predicted immunological boosting from higher pre-vaccine titres after 2009 pandemic H1N1 vaccination only occurred in children (seroconversion rate = 92%) and not in individuals aged 10 to 39 from risk groups (seroconversion rate = 74%). The lack of clinical protection identified in the same population in older adults from risk groups could be attributed to these lower seroresponses. Current immunogenicity licensing criteria for pandemic influenza vaccine may not correlate with clinical protection in individuals with chronic disease or immunocompromised.

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Conflict of interest statement

Competing Interests: N. Andrews and E. Miller have declared that no competing interests exist. C.F. Yung has received financial assistance from Sanofi-Pasteur and GlaxoSmithKline to attend conferences. K. Hoschler has been an investigator for clinical trials sponsored by Sanofi Pasteur, CSL Australia and Baxter but received no payment for this. K. Hoschler has on one occasion received financial assistance from Sanofi-Pasteur to attend a conference. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Distribution of fold responses pre to post Pandemrix™ vaccination by 2009 seasonal influenza vaccination status.
See this image and copyright information in PMC

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