Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study.

ABSTRACT:

Objective

Evaluation of the long-term HPV-16/18 AS04-adjuvanted vaccine immunogenicity persistence in women.

Design

Multicentre, open-label, long-term follow-up (NCT00947115) of a primary phase-III study (NCT00196937).

Setting

Six centres in Germany and Poland.

Population

488 healthy women (aged 15-55 years, age-stratified into groups: 15-25, 26-45, and 46-55 years) who received three vaccine doses in the primary study.

Methods

Immune responses were evaluated in serum and cervicovaginal secretion (CVS) samples 6 years after dose 1. Anti-HPV-16/18 geometric mean titres (GMTs) were measured by enzyme-linked immunosorbent assay (ELISA), and were used to fit the modified power-law and piecewise models, predicting long-term immunogenicity. Serious adverse eve

SUBMITTER: Schwarz T 

PROVIDER: S-EPMC4489326 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature