Research in context
Evidence before this study
Over the past decade, a wealth of clinical data for the efficacy of the HPV 16/18 AS04-adjuvanted vaccine has become available. The vaccine is now used in many countries worldwide as part of routine immunisation programmes. It offers protection against infection with HPV 16/18 and associated cytological abnormalities and precancerous cervical abnormalities in women. Efficacy against the non-vaccine types HPV 31 and HPV 45 has been shown consistently, and the large PATRICIA trial also observed cross-protection against HPV 33 and HPV 51. The vaccine also offers protection against precancerous cervical lesions irrespective of whether HPV was detected in the lesion, which is the closest indication of what would be expected in a real-world setting. Efficacy against oral, vulvar, and anal HPV infection has also been observed. Most trials have been conducted in young women aged 15–25 years; this design is also the case for the HPV 6/11/16/18 and HPV 6/11/16/18/31/33/52/58 vaccines, which are also widely available. One 4-year study of the HPV 6/11/16/18 vaccine in women aged 24–45 years has been reported, and we have previously reported an interim analysis of our VIVIANE study in women older than 25 years. The present report provides an update to VIVIANE at the end-of-study analysis, with continuing high vaccine efficacy observed over a 7-year follow-up.
Added value of this study
We provide new information about the efficacy of the HPV 16/18 vaccine up to 7 years of follow-up in adult women for whom few data are currently available. We show that the vaccine provides sustained protection against HPV infection, mildly abnormal cytology, and CIN1+ associated with HPV 16/18, together with cross-protection against infection with HPV 31 and HPV 45. Vaccine efficacy remained high despite probable exposure to HPV of most women in the trial.
Implications of all the available evidence
Adolescents are likely to remain the priority for most public health HPV vaccination programmes. However, new HPV infections can occur throughout adult life and we have shown that there is vaccine efficacy in this population group. Thus, adult women also have the potential to benefit from HPV vaccination and might choose to be vaccinated on an individual basis. On a broader scale, cost-effectiveness of vaccination in adult women remains an issue, but might be improved by changes in screening strategies incorporating vaccination and HPV testing—screen and vaccinate or vaccinate and screen strategies. The VIVIANE data provide strong evidence that the benefit of the HPV 16/18 vaccine extends to women older than 25 years of age, supporting the extension of vaccination to older women as suggested by HPV-FASTER. Finally, the 7-year follow-up of VIVIANE adds further evidence to the probable durability of cross-protective efficacy of the HPV 16/18 vaccine, regardless of age at vaccination.