Research Paper
Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine
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Volume 6, Issue 12 December 2010
Pages 1054 - 1061
http://dx.doi.org/10.4161/hv.6.12.13399
Authors: Tino F. Schwarz, Mariëlle Kocken, Tiina Petäjä, Mark H. Einstein, Marek Spaczynski, Jacqueline A. Louwers, Court Pedersen, Myron J. Levin, Toufik Zahaf, Sylviane Poncelet, Karin Hardt, Dominique Descamps and Gary Dubin
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- Tino F. Schwarz
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Corresponding author: t.schwarz@juliusspital.de
Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Wuerzburg, Germany
- Mariëlle Kocken
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Erasmus MC University Medical Center, Rotterdam, the Netherlands
- Tiina Petäjä
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University of Tampere, School of Public Health, Tampere, Finland
- Mark H. Einstein
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Montefiore Medical Center, Albert Einstein College of Medicine, Department of Obstetrics & Gynecology and Women’s Health, Division of Gynecologic Oncology, Bronx, NY USA
- Marek Spaczynski
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Department of Gynecology, Obstetrics and Gynecological Oncology, Poznan University of Medical Sciences, Poland
- Jacqueline A. Louwers
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VU University Medical Center, Amsterdam, the Netherlands
- Court Pedersen
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Odense University Hospital, Odense and Herlev Hospital, Copenhagen, Denmark
- Myron J. Levin
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University of Colorado Denver and Health Sciences Center, Aurora, CO USA
- Toufik Zahaf
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GlaxoSmithKline Biologicals, Wavre, Belgium
- Sylviane Poncelet
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GlaxoSmithKline Biologicals, Wavre, Belgium
- Karin Hardt
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GlaxoSmithKline Biologicals, Wavre, Belgium
- Dominique Descamps
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GlaxoSmithKline Biologicals, Wavre, Belgium
- Gary Dubin
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GlaxoSmithKline Biologicals, King of Prussia, PA USA
Abstract:
This pooled analysis of data from four Phase III clinical trials was undertaken to assess the correlation between levels of anti-human papillomavirus (HPV)-16/18 antibodies in serum and cervicovaginal secretions (CVS) in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine. Serum and CVS samples were collected from a subset of women aged 10–65 years (N=350) at pre-specified time-points from 7 to 36 months post-vaccination. Anti-HPV-16/18 antibody levels in serum and CVS were measured by enzyme-linked immunosorbent assay. Pearson correlation coefficients between serum and CVS antibody levels, standardized for total immunoglobulin G, were calculated at each time-point in women with detectable antibodies in both serum and CVS. All subjects had seroconverted at Month 7 and remained seropositive through Month 36 for both antigens. Geometric mean titers of anti-HPV-16/18 antibodies in serum were substantially higher at all time-points than those in a control group of women who had cleared a natural HPV infection in another trial. In women with detectable antibodies in both serum and CVS, good correlation was seen between HPV-16/18 antibody levels at all time-points (Pearson correlation coefficient: 0.84–0.92 for HPV-16 and 0.90–0.91 for HPV-18). The strong correlation between levels of HPV-16/18 antibodies in serum and CVS up to 36 months post-vaccination in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine supports transudation of serum antibodies as the mechanism by which antibodies are introduced into CVS. These CVS antibodies may play a role in the protective efficacy of this vaccine.
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