The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24.
BACKGROUND
Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18-related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV-associated cervico-genital lesions in a broad population of sexually active European women.


METHODS
Female subjects (N = 9265) aged 16-24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti-HPV 6/11/16/18 serology testing was also performed.


RESULTS
Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per-protocol population was 100.0%[95% confidence interval (95% CI), 89.8-100.0]. Efficacy against external genital lesions (vulvar or vaginal intraepithelial neoplasia, condyloma, vulvar or vaginal cancer) related to vaccine HPV types in the per-protocol European population was 99.0% (95% CI, 94.4-100.0).


CONCLUSIONS
These data demonstrate that quadrivalent HPV 6/11/16/18 vaccination programs in 16- to 24-year-old European women can be beneficial. NCT0009252, NCT00092534, NCT00092495.
Majewski
S
S
Department of Dermatology and Venereology, Center of Diagnostics and Treatment of Sexually Transmitted Diseases, Medical University of Warsaw, Warsaw, Poland. smajewski@kl.amwaw.edu.pl
Bosch
F X
FX
Dillner
J
J
Iversen
O-E
OE
Kjaer
S K
SK
Muñoz
N
N
Olsson
S-E
SE
Paavonen
J
J
Sigurdsson
K
K
Bryan
J
J
Esser
M T
MT
Giacoletti
K
K
James
M
M
Taddeo
F
F
Vuocolo
S
S
Barr
E
E
D000230:Adenocarcinoma / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012747:Sexual Partners; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control*
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D010919:Placebos