On the relationship between mean antibody level, seroprotection and clinical protection from influenza

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• 作者：Jozef J.P. Nauta ; Walter E.P. Beyer ; Albert D.M.E. Osterhaus
• 关键词：Influenza ; Antibody level ; Seroprotection ; Clinical protection ; Statistical modelling
• 刊名：Biologicals
• 出版年：2009
• 出版时间：August 2009
• 年：2009
• 卷：37
• 期：4
• 页码：216-221
• 全文大小：241 K

文摘

For many vaccines the amount of antibodies induced has a positive correlation with the likelihood of clinical protection from disease. Mean antibody level is therefore frequently used as a serological surrogate endpoint for vaccine efficacy. In addition, a dichotomous surrogate endpoint is often defined: seroprotection. We explore the relationship between mean antibody level, seroprotection and clinical protection from influenza, using a simple statistical model. The model reveals that the relationship depends not only on the mean but also on the dispersion of the antibody levels, the threshold for clinical protection and the clinical protection curve. The consequences for the interpretation of mean antibody levels and seroprotection rates in terms of clinical protection from influenza are discussed.