July 01, 2016
Although the risk of human papillomavirus (HPV) infection is greatest in younger women, the HPV vaccine continues to protect women older than 25 years of age against infections and complications of the virus, a new study reports.
In the phase 3, double-blind, randomized controlled VIVIANE study, healthy women older than 25 years of age were stratified by age and were randomly assigned (1:1) to receive HPV 16/18 vaccine or an aluminum hydroxide control.
A total of 5747 women were enrolled (n = 2877 vaccine, n = 2870 control). Up to 15% in each age stratum had a history of HPV infection or disease. The 4407 women women who were seronegative for the corresponding HPV type were included in the efficacy analysis (n = 2209 vaccine, n = 2198 control). The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or greater (CIN1+) associated with the vaccine.
After 7 years of follow-up, the efficacy of the vaccine against 6-month persistent infection or CIN1+ associated with HPV 16/18 was significant for all of the age groups combined (26–35 years, 36–45 years, and ≥46 years). The vaccine was also found to be cross-protective against HPV 31 and HPV 45. In the full study population, the vaccine was significantly protective against CIN1+ irrespective of HPV type.
Serious adverse events associated with vaccination in the trial were rare, occurring in 5 of 2877 women (0.2%) in the vaccine group and 8 of 2870 women (0.3%) in the control group.
The findings of the study support the use of the HPV vaccine in women older than 25 years.
Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, et al. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study [published online June 28, 2016]. Lancet Infect Dis. doi: 10.1016/S1473-3099(16)30120-7.