Long‐term persistence of immune response to the AS04‐adjuvanted HPV‐16/18 vaccine in Chinese girls aged 9‐17 years: Results from an 8‐9‐year follow‐up phase III open‐label study

AIM: In 9‐17‐year‐old Chinese girls, the AS04‐adjuvanted HPV‐16/18 vaccine (AS04‐HPV‐16/18) given as three‐dose schedule induced high antibody levels, which were noninferior 1 month after the third dose to those observed in 18‐25‐year‐old Chinese women in a large efficacy study. We assessed the persistence of antibodies 8‐9 years after vaccination in the same subjects. METHODS: This follow‐up phase III, open‐label study (NCT03355820) included subjects who had received three doses of AS04‐HPV‐16/18 in the initial trial (NCT00996125). Serum antibody concentrations were assessed by ELISA and compared to antibody persistence observed in 18‐25‐year‐old Chinese women 6 years after first vaccination in the efficacy study (NCT00779766). RESULTS: Out of the 227 enrolled subjects, 223 were included in the per‐protocol immunogenicity analysis. Mean interval from first AS04‐HPV‐16/18 dose to blood sampling was 101.4 months (8.5 years). For antibodies against HPV‐16 and ‐18, 8.5 years after first vaccine dose all subjects remained seropositive and antibody. Geometric mean concentrations (GMCs) were 1236.3 (95% confidence interval [CI]: 1121.8; 1362.4) and 535.6 (95% CI: 478.6; 599.4) ELISA Units/mL, respectively. These seropositivity rates and antibody GMCs were higher than those observed 6 years after first vaccination of 18‐25‐year‐old women. CONCLUSION: Sustained anti‐HPV‐16 and ‐18 immune responses were observed 8‐9 years after AS04‐HPV‐16/18 vaccination of 9‐17 year‐old Chinese girls that were higher than the ones observed 6 years after first vaccination in Chinese adult women in whom AS04‐HPV‐16/18 efficacy against cervical intraepithelial neoplasia of grade ≥2 was demonstrated.