End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age

X. Castellsagué, N. Mũoz, P. Pitisuttithum, Daron Gale Ferris, J. Monsonego, K. Ault, J. Luna, E. Myers, S. Mallary, O. M. Bautista, J. Bryan, S. Vuocolo, R. M. Haupt, A. Saah

Research output: Contribution to journalArticle

161 Citations (Scopus)

Abstract

Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.

Original languageEnglish (US)
Pages (from-to)28-37
Number of pages10
JournalBritish Journal of Cancer
Volume105
Issue number1
DOIs
StatePublished - Jun 28 2011

Fingerprint

Human papillomavirus 11
Human papillomavirus 6
Synthetic Vaccines
Papillomavirus Vaccines
Safety
Cervical Intraepithelial Neoplasia
Vaccines
Infection
Population
Condylomata Acuminata
Placebos
DNA
Incidence

Keywords

  • HPV
  • adult
  • cervical
  • vaccine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. / Castellsagué, X.; Mũoz, N.; Pitisuttithum, P.; Ferris, Daron Gale; Monsonego, J.; Ault, K.; Luna, J.; Myers, E.; Mallary, S.; Bautista, O. M.; Bryan, J.; Vuocolo, S.; Haupt, R. M.; Saah, A.

In: British Journal of Cancer, Vol. 105, No. 1, 28.06.2011, p. 28-37.

Research output: Contribution to journalArticle

Castellsagué, X, Mũoz, N, Pitisuttithum, P, Ferris, DG, Monsonego, J, Ault, K, Luna, J, Myers, E, Mallary, S, Bautista, OM, Bryan, J, Vuocolo, S, Haupt, RM & Saah, A 2011, 'End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age', British Journal of Cancer, vol. 105, no. 1, pp. 28-37. https://doi.org/10.1038/bjc.2011.185
Castellsagué, X. ; Mũoz, N. ; Pitisuttithum, P. ; Ferris, Daron Gale ; Monsonego, J. ; Ault, K. ; Luna, J. ; Myers, E. ; Mallary, S. ; Bautista, O. M. ; Bryan, J. ; Vuocolo, S. ; Haupt, R. M. ; Saah, A. / End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. In: British Journal of Cancer. 2011 ; Vol. 105, No. 1. pp. 28-37.
@article{e07867f6796741f9bd8bfbbbfcc3f83b,
title = "End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age",
abstract = "Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7{\%} (95{\%} CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9{\%} (95{\%} CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9{\%} of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.",
keywords = "HPV, adult, cervical, vaccine",
author = "X. Castellsagu{\'e} and N. Mũoz and P. Pitisuttithum and Ferris, {Daron Gale} and J. Monsonego and K. Ault and J. Luna and E. Myers and S. Mallary and Bautista, {O. M.} and J. Bryan and S. Vuocolo and Haupt, {R. M.} and A. Saah",
year = "2011",
month = "6",
day = "28",
doi = "10.1038/bjc.2011.185",
language = "English (US)",
volume = "105",
pages = "28--37",
journal = "British Journal of Cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
number = "1",

}

TY - JOUR

T1 - End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age

AU - Castellsagué, X.

AU - Mũoz, N.

AU - Pitisuttithum, P.

AU - Ferris, Daron Gale

AU - Monsonego, J.

AU - Ault, K.

AU - Luna, J.

AU - Myers, E.

AU - Mallary, S.

AU - Bautista, O. M.

AU - Bryan, J.

AU - Vuocolo, S.

AU - Haupt, R. M.

AU - Saah, A.

PY - 2011/6/28

Y1 - 2011/6/28

N2 - Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.

AB - Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.

KW - HPV

KW - adult

KW - cervical

KW - vaccine

UR - http://www.scopus.com/inward/record.url?scp=79959765563&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79959765563&partnerID=8YFLogxK

U2 - 10.1038/bjc.2011.185

DO - 10.1038/bjc.2011.185

M3 - Article

VL - 105

SP - 28

EP - 37

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

IS - 1

ER -