Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine : up to 8.4 years of follow-up
dc.contributor.author | Roteli-Martins, Cecilia M. | pt_BR |
dc.contributor.author | Naud, Paulo Sergio Viero | pt_BR |
dc.contributor.author | Borba, Paola Colares de | pt_BR |
dc.contributor.author | Teixeira, Júlio César | pt_BR |
dc.contributor.author | Carvalho, Newton S. de | pt_BR |
dc.contributor.author | Zahaf, Toufik | pt_BR |
dc.contributor.author | Sanchez, Nervo | pt_BR |
dc.contributor.author | Geeraerts, Brecht | pt_BR |
dc.contributor.author | Descamps, Dominique | pt_BR |
dc.date.accessioned | 2015-04-15T01:58:05Z | pt_BR |
dc.date.issued | 2012 | pt_BR |
dc.identifier.issn | 2164-554X | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/115328 | pt_BR |
dc.description.abstract | Prophylactic human papillomavirus (HPV) vaccines are now available and vaccination programs are being widely implemented, targeting adolescent girls prior to sexual debut. Since the risk of HPV exposure persists throughout a woman’s sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. We report the long-term efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine (Cervarix1) up to 8.4 y after the first vaccine dose. In an initial placebo-controlled study performed in US, Canada and Brazil, women aged 15–25 y with normal cervical cytology, HPV-16/18 seronegative by ELISA, DNA-negative for 14 oncogenic HPV types by PCR, received either the HPV- 16/18 vaccine or placebo (n = 1,113). Subjects were followed up to 6.4 y after the first dose (n = 776). We report an additional 2-y follow-up for women enrolled from the Brazilian centers from the initial study (n = 436). During the current follow-up study (HPV-023, NCT00518336), no new infection or lesions associated with HPV-16/18 occurred in the vaccine group. Vaccine efficacy over the entire follow-up (up to 8.4 y) was 95.1% (84.6, 99.0) for incident infection, 100% (79.8, 100) for 6-mo persistent infection, 100% (56.1, 100) for 12-mo persistent infection and 100% (, 0, 100) for CIN2+ associated with HPV-16/18. All women in the vaccine group remained seropositive to both HPV-16/ 18, with antibody titers for total and neutralizing antibodies remaining several-folds above natural infection levels. The safety profile was clinically acceptable for both vaccine and control groups. This is, to date, the longest follow-up study for a licensed cervical cancer vaccine. | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Human vaccines & immunotherapeutics. Philadelphia. Vol. 8, no. 3 (Mar. 2012), p. 390-397 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Papillomavirus humano 16 | pt_BR |
dc.subject | Human papillomavirus (HPV) | en |
dc.subject | Cervical cancer | en |
dc.subject | Papillomavirus humano 18 | pt_BR |
dc.subject | HPV-16/18 vaccine | en |
dc.subject | Revisão sistemática | pt_BR |
dc.subject | Prophylactic | en |
dc.subject | Vacinas contra papillomavirus | pt_BR |
dc.subject | Long-term immunogenicity | en |
dc.subject | Efficacy | en |
dc.title | Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine : up to 8.4 years of follow-up | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 000953299 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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