Publication: 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.
Accepted Date
2011-04-26
Issued Date
2011-06-28
Copyright Date
2011
Resource Type
Language
eng
ISSN
0007-0920 (printed)
Rights Holder(s)
British Journal of Cancer
Bibliographic Citation
Castellsagué X, Muñoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K. et al. 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. Br J Cancer. 2011 Jun 28;105(1):28-37.
Suggested Citation
Castellsagué, X, Muñoz, N, Punnee Pitisuttithum, พรรณี ปิติสุทธิธรรม, Ferris, D, Monsonego, J, Ault, K, Luna, J, Myers, E, Mallary, S, Bautista, OM, Bryan, J, Vuocolo, S, Haupt, RM, 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.. Castellsagué X, Muñoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K. et al. 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. Br J Cancer. 2011 Jun 28;105(1):28-37.. doi:10.1038/bjc.2011.185. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/810
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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.
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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.