The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years.
BACKGROUND
We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment.


METHODS
Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received 1 dose and returned for follow-up were included.


RESULTS
Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant.


CONCLUSIONS
These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings.


BACKGROUND
ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.
Wheeler
Cosette M
CM
University of New Mexico, Department of Molecular Genetics and Microbiology, Albuquerque, NM 87131, USA. cwheeler@salud.unm.edu
Kjaer
Susanne K
SK
Sigurdsson
Kristján
K
Iversen
Ole-Erik
OE
Hernandez-Avila
Mauricio
M
Perez
Gonzalo
G
Brown
Darron R
DR
Koutsky
Laura A
LA
Tay
Eng Hseon
EH
García
Patricia
P
Ault
Kevin A
KA
Garland
Suzanne M
SM
Leodolter
Sepp
S
Olsson
Sven-Eric
SE
Tang
Grace W K
GW
Ferris
Daron G
DG
Paavonen
Jorma
J
Steben
Marc
M
Bosch
F Xavier
FX
Dillner
Joakim
J
Joura
Elmar A
EA
Kurman
Robert J
RJ
Majewski
Slawomir
S
Muñoz
Nubia
N
Myers
Evan R
ER
Villa
Luisa L
LL
Taddeo
Frank J
FJ
Roberts
Christine
C
Tadesse
Amha
A
Bryan
Janine
J
Lupinacci
Lisa C
LC
Giacoletti
Katherine E D
KE
James
Margaret
M
Vuocolo
Scott
S
Hesley
Teresa M
TM
Barr
Eliav
E
D000230:Adenocarcinoma / Q000517:prevention & control / Q000821:virology; D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics / Q000276:immunology*; D005260:Female; D006801:Humans; D030361:Papillomavirus Infections / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control / Q000821:virology
D053918:Papillomavirus Vaccines