Journal article

Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

KA Ault, EA Joura, SK Kjaer, OE Iversen, CM Wheeler, G Perez, DR Brown, LA Koutsky, SM Garland, SE Olsson, GWK Tang, DG Ferris, J Paavonen, M Steben, FX Bosch, S Majewski, N Muñoz, HL Sings, K Harkins, MA Rutkowski Show all

International Journal of Cancer | Published : 2011

Abstract

The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2, and 6. Women underwent colposcopy and biopsy according to a Papanicolaou triage algorithm. All tissue s..

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University of Melbourne Researchers

Grants

Funding Acknowledgements

[ "We thank all study participants and investigators. We also thank Margaret James (Merck and Co., Inc.) for statistical assistance and Karyn Davis (Merck and Co., Inc.) for publication assistance. Merck Research Laboratories, a Division of Merck & Company, Inc., funded these studies.", "KAA, EAJ, SKK, OEI, CMW, GP, DRB, LAK, SMG, SEO, DGF, MS, and FXB have received funding through their respective company or institution to conduct HPV vaccine studies for Merck. In addition, KAA has received consultancy and advisory board fees from Merck, and has received funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline, Roche, and the National Institute for Allergy and Infectious Diseases, and for nonvaccine clinical trials for Gen-Probe. EAJ has received advisory board fees from Merck and Sanofi Pasteur MSD and has received funding through his institution to conduct epidemiological HPV studies for GlaxoSmithKline. He has also received lecture fees from Merck, Sanofi Pasteur MSD and GlaxoSmithKline. SKK has received consultancy fees from Merck and Co., Inc., and has received funding through her institution to conduct HPV vaccine studies for Sanofi Pasteur MSD and Digene. OEI has received lecture fees from Merck and Co., Inc. and GlaxoSmithKline. CMW has received funding through her institution for reagents and equipment for Roche Molecular Systems in support of HPV genotyping studies and to conduct HPV vaccine studies for GlaxoSmithKline. GP has received lecture fees and consultancy fees from Merck and Co., Inc. and Sanofi Pasteur MSD, and is now an employee of the Sponsor, Merck and Co., Inc. DRB has received lecture fees, advisory board fees and intellectual property fees from Merck and Co., Inc. SMG has received advisory board fees and grant support from Commonwealth Serum Laboratories and GlaxoSmithKline, and lecture fees from Merck and Co., Inc., GSK and Sanofi Pasteur, as well as received research funds through her institution to conduct HPV vaccine studies for GSK. She is a member of the Merck Global Advisory Board as well as the Merck Scientific Advisory Committee for HPV. SEO has received lecture fees from Merck and Co., Inc. DGF has received consultancy, lecture and advisory board fees from Merck and Co. Inc. and has received funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline. MS has received lecture fees and grant support from Merck and Co., Inc. and has received unrestricted research grants for epidemiological studies from Merck. FXB has received lecture fees from Merck and Co., Inc. and GlaxoSmithKline, and has received funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline and Sanofi Pasteur MSD and has received unrestricted research grants for epidemiological studies from GlaxoSmithKline and Sanofi Pasteur MSD. GWKT received research funding for the FUTURE study on Quadrivalent HPV vaccine from 2002 for 5 years from Merck and Co., Inc. SM has received lecture fees and advisory board fees from Merck and Co., Inc. NM has received lecture fees, advisory board fees and consultancy fees from Merck and Co., Inc. and Sanofi Pasteur MSD. GP, HLS, KH, MAR, RMH, and EIOG are employees of Merck and Co., Inc. and potentially own stock and/or stock options in the company." ]