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