Sustained efficacy and immunogenicity of the HPV-16/18 ASO4-adjuvanted vaccine up to 7.3 years in young adult women

被引：115

作者：

De Carvalho, N. ^{[1
]}

Teixeira, J. ^{[2
]}

Roteli-Martins, C. M. ^{[3
]}

Naud, P. ^{[4
]}

De Borba, P. ^{[5
]}

Zahaf, T. ^{[6
]}

Sanchez, N. ^{[7
]}

Schuind, A. ^{[8
]}

机构：

[1] Univ Fed Parana, Hosp Clin, Setor Infeccoes Ginecol & Obstet, BR-80430160 Curitiba, Parana, Brazil

[2] Univ Campinas UNICAMP, Ctr Atencao Integral Saude Mulher, Campinas, SP, Brazil

[3] Hosp Leonor Mendes de Barros, Secretaria Saude Sao Paulo, Sao Paulo, Brazil

[4] Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil

[5] Inst Prevencao Canc Ceara, Fortaleza, Ceara, Brazil

[6] GlaxoSmithKline Biol, Rixensart, Belgium

[7] GlaxoSmithKline Biol, Rio De Janeiro, Brazil

[8] GlaxoSmithKline Biol, King Of Prussia, PA USA

来源：

VACCINE | 2010年 / 28卷 / 38期

关键词：

HPV-16/18; vaccine; Long-term efficacy; Cervical cancer; HUMAN-PAPILLOMAVIRUS TYPE-16; SUBSEQUENT HPV INFECTION; PARTICLE VACCINE; NEUTRALIZATION ASSAY; ANTIBODY-RESPONSE; NATURAL-HISTORY; LATIN-AMERICA; PREVALENCE; RISK; PERSISTENCE;

D O I：

10.1016/j.vaccine.2010.07.007

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

We report efficacy and immunogenicity of the HPV-16/18 ASO4-adjuvanted vaccine up to 7.3 years post-vaccination. The study was conducted in a population (N = 433) of women enrolled in Brazilian centres from an initial placebo-controlled study. Women were aged 15-25 years at first vaccination. During the most recent year of follow-up, approximately 7 years after initial vaccination, no cases of infection or cytohistological lesions associated with HPV-16/18 were observed in the vaccinees. Vaccine efficacy (95% confidence interval) up to 7.3 years was 94.5% (82.9, 98.9) for incident infection, 100% (55.7, 100) for 12-month persistent infection and 100% (-129.8, 100) for cervical intraepithelial neoplasia grade 2+. Antibody titres for total IgG and neutralising antibodies remained several folds above natural infection levels and >= 96% of women were seropositive. Vaccine safety was similar to placebo. This is the longest follow-up study for a licensed cervical cancer vaccine. (C) 2010 Elsevier Ltd. All rights reserved.

引用

页码：6247 / 6255

页数：9

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