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Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

Szarewski, A. ; Poppe, W.A.J. ; Skinner, S.R. ; Wheeler, C.M. ; Paavonen, J. ; Naud, P. ; Salmeron, J. ; Chow, S.-N. ; Apter, D. ; Kitchener, H. ; Castellsagué, X. ; Teixeira, J.C. ; Hedrick, J. ; Jaisamrarn, U. ; Limson, G. ; Garland, S. ; Romanowski, B. ; Aoki, F.Y. ; Schwarz, T.F. ; Bosch, F.X. ; Harper, D.M. ; Hardt, K. ; Zahaf, T. ; Descamps, D. ; Struyf, F. ; Lehtinen, M. ; Dubin, G.

International journal of cancer, 2012-07, Vol.131 (1), p.106-116 [Peer Reviewed Journal]

Hoboken: Wiley Subscription Services, Inc., A Wiley Company

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Title:
Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18
Author: Szarewski, A. ; Poppe, W.A.J. ; Skinner, S.R. ; Wheeler, C.M. ; Paavonen, J. ; Naud, P. ; Salmeron, J. ; Chow, S.-N. ; Apter, D. ; Kitchener, H. ; Castellsagué, X. ; Teixeira, J.C. ; Hedrick, J. ; Jaisamrarn, U. ; Limson, G. ; Garland, S. ; Romanowski, B. ; Aoki, F.Y. ; Schwarz, T.F. ; Bosch, F.X. ; Harper, D.M. ; Hardt, K. ; Zahaf, T. ; Descamps, D. ; Struyf, F. ; Lehtinen, M. ; Dubin, G.
Subjects: Adjuvants, Immunologic ; Adolescent ; Adult ; Antibodies, Viral - blood ; Biological and medical sciences ; Cancer ; Cervical Intraepithelial Neoplasia - pathology ; Cervical Intraepithelial Neoplasia - prevention & control ; Cohort Studies ; Confidence intervals ; Deoxyribonucleic acid ; DNA ; DNA, Viral - blood ; Female ; Human papillomavirus ; Human papillomavirus 16 - immunology ; Human papillomavirus 18 - immunology ; human papillomavirus vaccines ; human papillomavirus-16 ; human papillomavirus-18 ; Humans ; Immunization ; Infections ; Infectious diseases ; Medical research ; Medical sciences ; Papillomavirus Infections - immunology ; Papillomavirus Infections - pathology ; Papillomavirus Infections - prevention & control ; Papillomavirus Infections - virology ; Papillomavirus Vaccines - administration & dosage ; Papillomavirus Vaccines - adverse effects ; Papillomavirus Vaccines - immunology ; previous exposure ; Treatment Outcome ; Tumors ; Vaccination ; vaccine efficacy against human papillomavirus-16/18 ; Vaccines ; Viral diseases ; Young Adult
Is Part Of: International journal of cancer, 2012-07, Vol.131 (1), p.106-116
Notes: Conflicts of interest: DD, GD, FS, KH, and TZ are employees of GlaxoSmithKline Biologicals. DD, GD, FS and KH own stock in GlaxoSmithKline Biologicals, and GD holds a relevant patent. All investigators at study clinical sites were funded through their institutions to do the study protocol. PN, SRS, FYA, SG, ML, JCT, TFS, CMW, WAJP, DMH, FXB, XC and BR have received funding through their institutions to do other HPV vaccine studies for GlaxoSmithKline Biologicals and/or Merck & Co., Inc. Sharp & Dohme, Sanofi Pasteur MSD. CMW has also received reagents and equipment through her institution from Roche Molecular Systems to do HPV genotyping studies. SG has received advisory board fees and grant support from CSL and GlaxoSmithKline. SG has received lecture fees from Merck, GSK and Sanofi Pasteur. FXB, XC, PN, WAJP, BR, AS and JCT have received consulting fees in the past 3 years. FXB has received payment for participating in speakers bureau. JCT, TFS, BR and DMH have received payments from Merck and/or GlaxoSmithKline Biologicals for participating in advisory boards. SG is a member of the Merck Global Advisory Board as well as the Merck Scientific Advisory Committee for HPV. DMH, FYA, XC, PN, BR, TFS, SRS, AS and WJAP have received honoraria, paid expert testimony, or travel grants from GlaxoSmithKline Biologicals. JS, JP, JH, HK, DA, S-NC, UJ and GL declare that they have no conflicts of interest.
ark:/67375/WNG-RS2MZJ86-0
istex:4DB0F5E4EA588C6E1E652A2CD83116F4324DF361
GlaxoSmithKline Biologicals - No. NCT00122681; No. 580299/008
ArticleID:IJC26362
A.S. and W.A.J.P. contributed equally to this work
Fax: +32‐16‐344205
Conflicts of interest: DD, GD, FS, KH, and TZ are employees of GlaxoSmithKline Biologicals. DD, GD, FS and KH own stock in GlaxoSmithKline Biologicals, and GD holds a relevant patent. All investigators at study clinical sites were funded through their institutions to do the study protocol. PN, SRS, FYA, SG, ML, JCT, TFS, CMW, WAJP, DMH, FXB, XC and BR have received funding through their institutions to do other HPV vaccine studies for GlaxoSmithKline Biologicals and/or Merck & Co., Inc. Sharp & Dohme, Sanofi Pasteur MSD. CMW has also received reagents and equipment through her institution from Roche Molecular Systems to do HPV genotyping studies. SG has received advisory board fees and grant support from CSL and GlaxoSmithKline. SG has received lecture fees from Merck, GSK and Sanofi Pasteur. FXB, XC, PN, WAJP, BR, AS and JCT have received consulting fees in the past 3 years. FXB has received payment for participating in speakers bureau. JCT, TFS, BR and DMH have received payments from Merck and/or GlaxoSmithKline Biologicals for participating in advisory boards. SG is a member of the Merck Global Advisory Board as well as the Merck Scientific Advisory Committee for HPV. DMH, FYA, XC, PN, BR, TFS, SRS, AS and WJAP have received honoraria, paid expert testimony, or travel grants from GlaxoSmithKline Biologicals. JS, JP, JH, HK, DA, S‐NC, UJ and GL declare that they have no conflicts of interest.
Fax: +44‐20‐7882‐3890
Description: In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)‐16/18 AS04‐adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) was highly efficacious against HPV‐16/18 infections and precancerous lesions in women HPV‐16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV‐16/18 in the total vaccinated cohort including women who may have been exposed to HPV‐16/18 infection before vaccination. In women with no evidence of current or previous HPV‐16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3–92.6) against 6‐month persistent infection (PI), 91.9% (84.6–96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3–98.4) against CIN2+ [97.7% (91.1–99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV‐16/18 DNA negative but with serological evidence of previous HPV‐16/18 infection (seropositive), VE was 72.3% (53.0–84.5) against 6‐month PI, 67.2% (10.9–89.9) against CIN1+, and 68.8% (−28.3–95.0) against CIN2+ [88.5% (10.8–99.8) when using TAA]. In women with no evidence of current HPV‐16/18 infection (DNA negative), regardless of their baseline HPV‐16/18 serological status, VE was 88.7% (85.7–91.1) against 6‐month PI, 89.1% (81.6–94.0) against CIN1+ and 92.4% (84.0–97.0) against CIN2+ [97.0% (90.6–99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV‐16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV‐16/18 DNA or serological status at entry.
Publisher: Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Language: English

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Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

Hoboken: Wiley Subscription Services, Inc., A Wiley Company

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