Journal article
Impact of an HPV6/11/16/18 L1 virus-like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection
RM Haupt, CM Wheeler, DR Brown, SM Garland, DG Ferris, JA Paavonen, MO Lehtinen, M Steben, EA Joura, KED Giacoletti, DR Radley, MK James, AJ Saah, HL Sings
International Journal of Cancer | Published : 2011
DOI: 10.1002/ijc.25940
Abstract
The impact of a human papillomavirus (HPV) vaccine on development of cervical intraepithelial neoplasia grade 2-3 or adenocarcinoma in situ (CIN2-3/AIS) in women with ongoing HPV16 or 18 infections prevaccination is reported. Seventeen thousand six-hundred and twenty-two women aged 16-26 were enrolled in 1 of 2 randomized, placebo-controlled, efficacy trials (Protocols 013 and 015). Vaccine or placebo was given at day 1, month 2 and 6. Women were tested for HPV6/11/16/18 DNA and antibodies at day 1. We focus on the subset of women who were seropositive and DNA positive to HPV16 or HPV18 prevaccination. Incidence is expressed as the number of women with an endpoint per 100 person-years-at-ris..
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Awarded by Merck Sharp Dohme, Corp.
Funding Acknowledgements
[ "All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf. C.M.W., D.R.B., S.M.G., D.G.F., J.P., M.L., M.S. and E.A.J. have received funding through their institutions to conduct HPV vaccine studies for Merck Sharp & Dohme, Corp. C.M.W. has received funding through her institution for reagents and equipment from Roche Molecular Systems in support of HPV genotyping studies and to conduct HPV vaccine studies for GlaxoSmithKline. D.R.B. has received lecture fees, advisory board fees, and intellectual property fees from Merck Sharp & Dohme, Corp. M.S. has received lecture fees and grant support from Merck Sharp & Dohme, Corp. S.M.G. has received advisory board fees and grant support from Commonwealth Serum Laboratories and GlaxoSmithKline, lecture fees from Merck Sharp & Dohme, Corp., GlaxoSmithKline and Sanofi Pasteur MSD, as well as funding through her institution to conduct HPV vaccine study trials for GlaxoSmithKline. D.G.F. has received consultancy fees and funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline, and advisory board fees, consultancy fees and lecture fees from Merck Sharp & Dohme, Corp. J.P. has received consultancy fees, advisory board fees, and lecture fees from Merck Sharp & Dohme, Corp. and has received funding through his institution to conduct HPV vaccine studies for GlaxoSmithKline. M.S. has received lecture fees and grant support from Merck Sharp & Dohme, Corp. E.A.J. has received lecture fees from Merck Sharp & Dohme, Corp., Sanofi Pasteur MSD and GlaxoSmithKline and advisory board fees from Merck Sharp & Dohme, Corp. and Sanofi Paster MSD. R.M.H., K.E.D.G., D.R., M.K.J., A.S. and H.L.S. are employees of Merck Sharp & Dohme, Corp. and potentially own stock and/or stock options in the company.", "Grant sponsor: Merck Sharp & Dohme, Corp.", "Grant numbers: NCT00092521, NCT00092534" ]