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Objective  Evaluation of the long‐term  HPV ‐16/18  AS 04‐adjuvanted vaccine immunogenicity persistence in women.    Design  Multicentre, open‐label, long‐term follow‐up ( NCT 00947115) of a primary phase– III  study ( NCT 00196937).    Setting  Six centres in Germany and Poland.    Population  488 healthy women (aged 15–55 years, age‐stratified into groups: 15–25, 26–45, and 46–55 years) who received three vaccine doses in the primary study.    Methods  Immune responses were evaluated in serum and cervicovaginal secretion ( CVS ) samples 6 years after dose 1. Anti‐ HPV ‐16/18 geometric mean titres ( GMT s) were measured by enzyme‐linked immunosorbent assay ( ELISA ), and were used to fit the modified power‐law and piecewise models, predicting long‐term immunogenicity. Serious adverse events ( SAE s) were recorded.    Main outcome measures  Anti‐ HPV ‐16/18 seropositivity rates and  GMT s 6 years after dose 1.    Results  At 6 years after dose 1, all women were seropositive for anti‐ HPV –16 and ≥97% were seropositive for anti‐ HPV –18 antibodies.  GMT s ranged from 277.7 to 1344.6  EU /ml, and from 97.6 to 438.2  EU /ml, for anti‐ HPV –16 and anti‐ HPV –18, respectively. In all age groups,  GMT s were higher (anti‐ HPV –16, 9.3–45.1‐fold; anti‐ HPV –18, 4.3–19.4‐fold) than levels associated with natural infection (29.8  EU /ml). A strong correlation between serum and  CVS  anti‐ HPV ‐16/18 levels was observed, with correlation coefficients of 0.81–0.96 (anti‐ HPV –16) and 0.69–0.84 (anti‐ HPV –18). Exploratory modelling based on the 6–year data predicted vaccine‐induced anti‐ HPV ‐16/18 levels above natural infection levels for at least 20 years, except for anti‐ HPV –18 in the older age group (piecewise model). One vaccine‐related and two fatal  SAE s were reported.    Conclusions  At 6 years after vaccination, immune responses induced by the  HPV ‐16/18  AS 04‐adjuvanted vaccine were sustained in all age groups.

bjog: an international journal of obstetrics and gynaecology

Persistence of immune responses to the  HPV ‐16/18  AS 04‐adjuvanted vaccine in women aged 15–55 years and first‐time modelling of antibody responses in mature women: results from an open‐label 6–year follow‐up study