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Baseline characteristics and prevalence of HPV 6, 11, 16, 18 in young German women participating in phase III clinical trials of a quadrivalent HPV (6/11/16/18) vaccine

Archives of Gynecology and Obstetrics volume 279, pages 803–807 (2009)Cite this article

Abstract

Introduction

As limited data among German women exist about HPV, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae, we report the prevalence of these genital infections and general baseline demographics of the young German women enrolled in the phase III trials of the quadrivalent HPV vaccine.

Materials and methods

German females (n = 437; 9–23 years) were recruited among 3 international phase 3 studies of an HPV-6/11/16/18 vaccine. We present baseline characteristics, prevalence of HPV-6/11/16/18 and, for women aged 16–23, abnormal cervical cytology and sexually transmitted diseases.

Results

Chlamydia trachomatis and Neisseria gonorrhoeae prevalence was 5 and 0.3%, respectively. Approximately 17% of participants had HPV-6, 11, 16, or 18 DNA or antibodies. All subjects <17 years were naïve to the four vaccine types.

Discussion

The results of the vaccine trials have demonstrated that it is worth administering prophylactic HPV vaccines before sexual debut; however, none of these sexually active German women were positive to all four types and most were positive to only one type. Thus, all women had the potential to benefit from vaccination with a quadrivalent HPV vaccine.

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Acknowledgments

Merck Research Laboratories, a division of Merck and Co., Inc., funded this study in its entirety. A portion of these data were presented at the 2007 Joint Annual Bavarian-Austrian Congress on Gynaecology and Obstetrics. Drs Barthell, Woelber, Hellner, Camerer, Gieseking, Hauschild, and Friese report having received funding from Merck through their respective institutions to conduct clinical trials of this vaccine. Drs Sings and Barr are employees of Merck and Co., Inc. and hold stock and/or stock options. Dr Barthell has received lecture fees from speaking at the invitation of Sanofi-Pasteur Merck Sharp & Dohme.

Conflict of interest statement

Barthell, Woelber, Hellner, Camerer, Gieseking, Hauschild, and Friese report having received funding from Merck through their respective institutions to conduct clinical trials of this vaccine. Drs Sings and Barr are employees of Merck and Co., Inc. and hold stock and/or stock options. Dr. Barthell has received lecture fees from speaking at the invitation of Sanofi-Pasteur Merck Sharp & Dohme. Merck Research Laboratories funded this study in its entirety.

Author information

Author notes

  1. Karin Hellner

    Present address: The Channing Laboratory, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA

Affiliations

  1. First Department of Obstetrics and Gynaecology – Klinikum Innenstadt, Ludwig-Maximilian-University Munich, Maistrasse 11, 80337, Munich, Germany

    Elisabeth Barthell, Birka Camerer, Ioannis Mylonas & Klaus Friese

  2. Universitaetsklinik Hamburg-Eppendorf, Hamburg, Germany

    Linn Woelber & Friederike Gieseking

  3. Charite University Hospital of Berlin, Berlin, Germany

    Karin Hellner

  4. Frauenklinik und Brustzentrum Rheinfelden, Rheinfelden, Germany

    Maik Hauschild

  5. Merck Research Laboratories, Westpoint, USA

    Heather L. Sings, Radha Railkar, Christine Gause & Eliav Barr

  6. Maistrasse 11, 80337, Munich, Germany

    Ioannis Mylonas

Authors
  1. Elisabeth Barthell
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  2. Linn Woelber
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  9. Heather L. Sings
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  11. Christine Gause
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Corresponding author

Correspondence to Ioannis Mylonas.

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Barthell, E., Woelber, L., Hellner, K. et al. Baseline characteristics and prevalence of HPV 6, 11, 16, 18 in young German women participating in phase III clinical trials of a quadrivalent HPV (6/11/16/18) vaccine. Arch Gynecol Obstet 279, 803–807 (2009). https://doi.org/10.1007/s00404-008-0806-1

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Keywords

  • HPV prevalence
  • Prophylactic quadrivalent HPV vaccine
  • Cervical cytology
  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Female