Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

Luisa L Villa; J Stapleton; J. T Cox; Gonzalo Perez; P Jensen; Susanne K Kjaer; B Allen; Jorma Paavonen; Matti Lehtinen; Nubia Munoz; L Zhang; Kristjan Sigurdsson; Mauricio Hernandez-Avila; Finn Egil Skjeldestad; Steinar Thoresen; Patricia Garcia; F. Xavier Bosch; Slawomir Majewski; Sven-Eric Olsson; Darron R Brown; Joakim Dillner; Eng Hseon Tay; Laura A Koutsky; Kevin A Ault; Robert J Kurman; Evan R Myers; Eliav Barr; John Boslego; Janine Bryan; Mark T Esser; Christine K Gause; Teresa M Hesley; Lisa C Lupinacci; Heather L Sings; Frank J Taddeo; Annemarie R Thornton; M Boulos; F Langmark; J Modlin; A Munoz; V Odlind; E Wilkinson; A Ferenczy; B Ronett; M Stoler; G Andreoni; L Bahamondes; A Camargos; R Costa; R De Andrade; E Fedrizzi; R Ferriani; M Goncalves; F Laginha; J Mendonca; E., Jr Moreira; B Nonnenmacher; W Taborda; D Zanetta; J Ardila; N Balcazar; I Maldonado; F Revollo; A Ruiz; E. S Andersen; H Djursing; T Hansen; J. J Jorgensen; L Nilas; B Ottesen; L. K Petersen; S. G Thomsen; K Toftager-Larsen; D Apter; M Kekki; M Kuortti; L Lahti; Y Lindroos; T Lunnas; J Palmroth; K Sigurdsson; E Lazcano; J Zertuche; K Dalaker; B Eriksen; L. E Erno; B Fiane; K Hesla; M. Myhre Isachsen; O. E Iversen; K Kasin; M Kristoffersen; T Lunde; P. T Nordmark; T Nygaard; M Onsrud; G Riis-Johannessen; H Schiotz; F. E Skjeldestad; H Sundhagen; O Sviggum; K. A Trosterud; P Garcia; M Penny; A Vivar; A Basta; K Czajkowski; P Knapp; M Spaczynski; R Barnes; E. H Tay; K Elfgren; E Hardmeier; C Hellsten; C Hofte; G Johannisson; G. -B Loewhagen; S. -E Olsson; M Steinwall; L Tamsen; T Varnauskas; A Wikstroem; G Crawford; R Edwards; J Comerci; A Giuliano; S Greer; K Hatch; J Kriesel; J Lalezari; E Partridge; R Sperling; S Spruance; P Wright; P Zedler; K McCarroll; H Zhou; FUTURE II Study Group

doi:10.1056/NEJMoa061741

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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

Journal article

Open access

Peer reviewed

Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

Luisa L Villa, J Stapleton, J. T Cox, Gonzalo Perez, P Jensen, Susanne K Kjaer, B Allen, Jorma Paavonen, Matti Lehtinen, Nubia Munoz, …

The New England journal of medicine, Vol.356(19), pp.1915-1927

2007

DOI: 10.1056/NEJMoa061741

PMID: 17494925

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Abstract

BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.

Basic Medicine

Medical and Health Sciences

Microbiology in the medical area

Mikrobiologi inom det medicinska området

Medicin och hälsovetenskap

Medicinska och farmaceutiska grundvetenskaper

Details

Title: Subtitle: Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
Creators: Luisa L Villa
J Stapleton
J. T Cox
Gonzalo Perez
P Jensen
Susanne K Kjaer
B Allen
Jorma Paavonen
Matti Lehtinen
Nubia Munoz
L Zhang
Kristjan Sigurdsson
Mauricio Hernandez-Avila
Finn Egil Skjeldestad
Steinar Thoresen
Patricia Garcia
F. Xavier Bosch
Slawomir Majewski
Sven-Eric Olsson
Darron R Brown
Joakim Dillner - Clinical Microbiology, Malmö
Eng Hseon Tay
Laura A Koutsky
Kevin A Ault
Robert J Kurman
Evan R Myers
Eliav Barr
John Boslego
Janine Bryan
Mark T Esser
Christine K Gause
Teresa M Hesley
Lisa C Lupinacci
Heather L Sings
Frank J Taddeo
Annemarie R Thornton
M Boulos
F Langmark
J Modlin
A Munoz
V Odlind
E Wilkinson
A Ferenczy
B Ronett
M Stoler
G Andreoni
L Bahamondes
A Camargos
R Costa
R De Andrade
E Fedrizzi
R Ferriani
M Goncalves
F Laginha
J Mendonca
E., Jr Moreira
B Nonnenmacher
W Taborda
D Zanetta
J Ardila
N Balcazar
I Maldonado
F Revollo
A Ruiz
E. S Andersen
H Djursing
T Hansen
J. J Jorgensen
L Nilas
B Ottesen
L. K Petersen
S. G Thomsen
K Toftager-Larsen
D Apter
M Kekki
M Kuortti
L Lahti
Y Lindroos
T Lunnas
J Palmroth
K Sigurdsson
E Lazcano
J Zertuche
K Dalaker
B Eriksen
L. E Erno
B Fiane
K Hesla
M. Myhre Isachsen
O. E Iversen
K Kasin
M Kristoffersen
T Lunde
P. T Nordmark
T Nygaard
M Onsrud
G Riis-Johannessen
H Schiotz
F. E Skjeldestad
H Sundhagen
O Sviggum
K. A Trosterud
P Garcia
M Penny
A Vivar
A Basta
K Czajkowski
P Knapp
M Spaczynski
R Barnes
E. H Tay
K Elfgren
E Hardmeier
C Hellsten
C Hofte
G Johannisson
G. -B Loewhagen
S. -E Olsson
M Steinwall
L Tamsen
T Varnauskas
A Wikstroem
G Crawford
R Edwards
J Comerci
A Giuliano
S Greer
K Hatch
J Kriesel
J Lalezari
E Partridge
R Sperling
S Spruance
P Wright
P Zedler
K McCarroll
H Zhou
FUTURE II Study Group
Resource Type: Journal article
Publication Details: The New England journal of medicine, Vol.356(19), pp.1915-1927
DOI: 10.1056/NEJMoa061741
PMID: 17494925
NLM abbreviation: N Engl J Med
ISSN: 0028-4793
eISSN: 1533-4406
Language: English
Date published: 2007
Academic Unit: Microbiology and Immunology; Infectious Diseases; Internal Medicine
Record Identifier: 9984094650702771

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