A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (Types 6/11/16/18) vaccine against high-grade cervical and external genital lesions.
Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.
Department of Virus, Hormones and Cancer, Institute of Cancer Epidemiology, Danish Cancer Society/Rigshospitalet, Copenhagen, Denmark. susanne@cancer.dk
Susanne K
SK
Kjaer
Kristján
K
Sigurdsson
Ole-Erik
OE
Iversen
Mauricio
M
Hernandez-Avila
Cosette M
CM
Wheeler
Gonzalo
G
Perez
Darron R
DR
Brown
Laura A
LA
Koutsky
Eng Hseon
EH
Tay
Patricia
P
García
Kevin A
KA
Ault
Suzanne M
SM
Garland
Sepp
S
Leodolter
Sven-Eric
SE
Olsson
Grace W K
GW
Tang
Daron G
DG
Ferris
Jorma
J
Paavonen
Matti
M
Lehtinen
Marc
M
Steben
F Xavier
FX
Bosch
Joakim
J
Dillner
Elmar A
EA
Joura
Slawomir
S
Majewski
Nubia
N
Muñoz
Evan R
ER
Myers
Luisa L
LL
Villa
Frank J
FJ
Taddeo
Christine
C
Roberts
Amha
A
Tadesse
Janine
J
Bryan
Roger
R
Maansson
Shuang
S
Lu
Scott
S
Vuocolo
Teresa M
TM
Hesley
Alfred
A
Saah
Eliav
E
Barr
Richard M
RM
Haupt
D000293:Adolescent; D000328:Adult; D019496:Cancer Vaccines / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D005831:Genital Diseases, Female / Q000517:prevention & control / Q000821:virology; D052140:Human papillomavirus 11; D052162:Human papillomavirus 16; D052161:Human papillomavirus 18; D052163:Human papillomavirus 6; D006801:Humans; D015337:Multicenter Studies as Topic; D030361:Papillomavirus Infections / Q000150:complications / Q000517:prevention & control / Q000821:virology; D053918:Papillomavirus Vaccines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control* / Q000821:virology
D019496:Cancer Vaccines; D053918:Papillomavirus Vaccines