To estimate the proportion of vulvovaginal lesions in young women attributable to human papillomavirus (HPV) types preventable by the 9vHPV vaccine.
Prospectively diagnosed vulvar and vaginal low- and high-grade squamous intraepithelial lesions (LSILs and HSILs, respectively) among 8,798 women 15–26 years old enrolled in the placebo arms of 2 phase 3 randomized HPV-vaccine trials were analyzed for the presence of 14 HPV genotypes (6/11/16/18/31/33/35/39/45/51/52/56/58/59).
Overall, 40 vulvar LSILs, 46 vulvar HSILs, 118 vaginal LSILs, and 33 vaginal HSILs were detected ~4 years of follow-up. At least one of the 14 types was detected in 72.5%, 91.3%, 61.9%, and 72.7% of these lesions, and multiple HPV types were detected in 40.3%, 30.4%, 24.1%, and 45.2% of the HPV-positive lesions, respectively. After accounting for co-infections, 60.0-67.5% of vulvar LSILs, 76.1-91.3% of vulvar HSILs, 27.1-43.2% of vaginal LSILs, and 42.4-60.6% of vaginal HSILs were attributable to 9vHPV vaccine types. Among the HPV-positive lesions, 89.4% of vulvar LSILs, 100% of vulvar HSILs, 56.0% of vaginal LSILs, and 78.3% of vaginal HSILs were attributable to 9vHPV vaccine types, accounting for 1.7% of vulvar LSILs, 16.1% of vulvar HSILs, 30.8% of vaginal LSILs, and 20.9% of vaginal HSILs (Table).
Widespread uptake of the 9vHPV vaccine could potentially prevent a sizeable fraction of benign and precancerous HPV-related vulvar and vaginal lesions.
Table. Proportionally weighted percentages of potentially vaccine-preventable HPV-positive vulvovaginal lesions.
Vaccine | 2vHPV | 4vHPV | 9vHPV | None1 | |
Targeted HPV genotypes2 | 16/18 | 6/11/16/18 | 6/11/16/18/31/33/45/52/58 | 35/39/51/56/59 | |
Vaginal |
LSIL |
18.8 | 25.2 | 56.0 | 44 |
HSIL |
53.1 |
57.4 | 78.3 | 21.7 | |
Vulvar | LSIL | 10.7 | 87.7 | 89.4 | 10.6 |
HSIL | 74.3 | 83.9 | 100.0 | 0.0 |
1Not covered by any of the 3 vaccines
2A total of 14 HPV types were assessed. Some lesions not categorized as HPV-related could have been caused by other HPV types for which genotyping was not performed. Some HPV types not genotyped could have been present in lesions categorized as HPV-related.