Abstract
Objective: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). Methods: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. Results: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6–99.7) and 97.8% (95% CI, 93.4–99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. Conclusions: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. Trial registrations: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
Original language | English (US) |
---|---|
Pages (from-to) | 110-117 |
Number of pages | 8 |
Journal | Gynecologic oncology |
Volume | 154 |
Issue number | 1 |
DOIs | |
State | Published - Jul 2019 |
Keywords
- Cervical cancer
- Cervical intraepithelial neoplasia (CIN)
- HPV
- Persistent infection
- Vaccine
- Vulvar intraepithelial neoplasia (VIN)
ASJC Scopus subject areas
- Oncology
- Obstetrics and Gynecology
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In: Gynecologic oncology, Vol. 154, No. 1, 07.2019, p. 110-117.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Nine-valent HPV vaccine efficacy against related diseases and definitive therapy
T2 - comparison with historic placebo population
AU - Giuliano, Anna R.
AU - Joura, Elmar A.
AU - Garland, Suzanne M.
AU - Huh, Warner K.
AU - Iversen, Ole Erik
AU - Kjaer, Susanne K.
AU - Ferenczy, Alex
AU - Kurman, Robert J.
AU - Ronnett, Brigitte M.
AU - Stoler, Mark H.
AU - Bautista, Oliver M.
AU - Moeller, Erin
AU - Ritter, Michael
AU - Shields, Christine
AU - Luxembourg, Alain
N1 - Funding Information: Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, a division of McCann Health Medical Communications Inc., Hackensack, NJ, USA and was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding Information: Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, a division of McCann Health Medical Communications Inc. Hackensack, NJ, USA and was funded by Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA. Funding for this study was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA. Employees of Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. (Kenilworth, NJ, USA), the sponsor and funder of the 9vHPV and qHPV vaccine studies, designed, managed, and analyzed the study in conjunction with external investigators. The sponsor was directly involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and the preparation and review of the manuscript. Each author had access to all study data upon request. The corresponding author had full access to all data in the study and a final version of the paper was approved by each co-author. The manuscript also underwent formal review by the sponsor. The decision to submit the manuscript for publication was made by the corresponding author in conjunction with the sponsor and co-authors. The sponsor did not have the potential to prevent submission of the manuscript. The opinions expressed in the manuscript represent the collective views of the authors and do not necessarily reflect the official position of the sponsor. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare the following. A.R.G.'s institution has received grants from Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. (Kenilworth, NJ) on her behalf for her research; she is a member of the Scientific Advisory Board for MSD. E.A.J. has received grants and personal fees from MSD and Sanofi Pasteur MSD. S.M.G. has received institutional grants to perform HPV studies from MSD, GSK, CSL, and the Commonwealth Department of Health, has received scientific advisory board support from MSD and speaking fees from MSD for work performed in her private time. W.K.H. has received fees as a consultant for MSD. O-E.I. has received personal fees from MSD for conducting clinical HPV vaccine trials and for scientific advisory committee meetings, and has received lecture fees from Sanofi Pasteur MSD. S.K.K. has received scientific advisory board fees from MSD, Sanofi Pasteur MSD, and BD; unrestricted research grants have been obtained through her affiliating institute from MSD. A.F. has acted as pathologist consultant for MSD in HPV vaccine clinical trials. R.J.K. has acted as a consultant as part of the central pathology panel for MSD. B.M.R. is part of the central pathology panel for the HPV vaccine trials and has a consulting agreement with MSD, paid to Johns Hopkins University. M.H.S. is part of the central pathology panel and a consultant on this clinical trial, and the University of Virginia received support from MSD for this activity. O.M.B. E.M. M.R. C.S. and A.L. are employees of Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA, who may own stock and/or hold stock options in Merck & Co. Inc. Kenilworth, NJ, USA. A.R.G. contributed to study conception, design, and planning, acquired data, and interpreted the results; she is guarantor of the study and attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. E.A.J. contributed to study conception, design, and planning, and acquired and analyzed the data. S.M.G. contributed to study conception, design, and planning, acquired data (FUTURE 1 study), and interpreted the results. W.K.H. analyzed the data and interpreted the results. O-E.I. and S.K.K. acquired the data and interpreted the results. A.F. interpreted the results. R.J.K. and B.M.R. acquired data. M.H.S. contributed to study conception, design, and planning, acquired and analyzed data, and interpreted the results. O.M.B. analyzed data, interpreted results, and provided statistical expertise. E.M. contributed to study conception, design, and planning, and analyzed the data. M.R. and A.L. contributed to study conception, design, and planning, and interpreted the results. C.S. contributed to study conception, design, and planning. A.R.G. E.A.J. O.M.B. and A.L. drafted the manuscript; all other authors critically reviewed or revised the manuscript for important intellectual content. All authors reviewed and approved the final version of the manuscript. Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA's data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to dataaccess@merck.com. Funding Information: Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, a division of McCann Health Medical Communications Inc. Hackensack, NJ, USA and was funded by Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA. Funding for this study was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA. Employees of Merck & Co. Inc. (Kenilworth, NJ, USA), the sponsor and funder of the 9vHPV and qHPV vaccine studies, designed, managed, and analyzed the study in conjunction with external investigators. The sponsor was directly involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and the preparation and review of the manuscript. Each author had access to all study data upon request. The corresponding author had full access to all data in the study and a final version of the paper was approved by each co-author. The manuscript also underwent formal review by the sponsor. The decision to submit the manuscript for publication was made by the corresponding author in conjunction with the sponsor and co-authors. The sponsor did not have the potential to prevent submission of the manuscript. The opinions expressed in the manuscript represent the collective views of the authors and do not necessarily reflect the official position of the sponsor. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare the following. A.R.G.'s institution has received grants from Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. (Kenilworth, NJ) on her behalf for her research; she is a member of the Scientific Advisory Board for MSD. E.A.J. has received grants and personal fees from MSD and Sanofi Pasteur MSD. S.M.G. has received institutional grants to perform HPV studies from MSD, GSK, CSL, and the Commonwealth Department of Health, has received scientific advisory board support from MSD and speaking fees from MSD for work performed in her private time. W.K.H. has received fees as a consultant for MSD. O-E.I. has received personal fees from MSD for conducting clinical HPV vaccine trials and for scientific advisory committee meetings, and has received lecture fees from Sanofi Pasteur MSD. S.K.K. has received scientific advisory board fees from MSD, Sanofi Pasteur MSD, and BD; unrestricted research grants have been obtained through her affiliating institute from MSD. A.F. has acted as pathologist consultant for MSD in HPV vaccine clinical trials. R.J.K. has acted as a consultant as part of the central pathology panel for MSD. B.M.R. is part of the central pathology panel for the HPV vaccine trials and has a consulting agreement with MSD, paid to Johns Hopkins University. M.H.S. is part of the central pathology panel and a consultant on this clinical trial, and the University of Virginia received support from MSD for this activity. O.M.B. E.M. M.R. C.S. and A.L. are employees of Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. who may own stock and/or hold stock options in Merck & Co. Inc. Kenilworth, NJ, USA. A.R.G. contributed to study conception, design, and planning, acquired data, and interpreted the results; she is guarantor of the study and attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. E.A.J. contributed to study conception, design, and planning, and acquired and analyzed the data. S.M.G. contributed to study conception, design, and planning, acquired data (FUTURE 1 study), and interpreted the results. W.K.H. analyzed the data and interpreted the results. O-E.I. and S.K.K. acquired the data and interpreted the results. A.F. interpreted the results. R.J.K. and B.M.R. acquired data. M.H.S. contributed to study conception, design, and planning, acquired and analyzed data, and interpreted the results. O.M.B. analyzed data, interpreted results, and provided statistical expertise. E.M. contributed to study conception, design, and planning, and analyzed the data. M.R. and A.L. contributed to study conception, design, and planning, and interpreted the results. C.S. contributed to study conception, design, and planning. A.R.G. E.A.J. O.M.B. and A.L. drafted the manuscript; all other authors critically reviewed or revised the manuscript for important intellectual content. All authors reviewed and approved the final version of the manuscript. Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. Kenilworth, NJ, USA's data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to dataaccess@merck.com. Publisher Copyright: © 2019 The Authors
PY - 2019/7
Y1 - 2019/7
N2 - Objective: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). Methods: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. Results: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6–99.7) and 97.8% (95% CI, 93.4–99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. Conclusions: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. Trial registrations: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
AB - Objective: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). Methods: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. Results: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6–99.7) and 97.8% (95% CI, 93.4–99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. Conclusions: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. Trial registrations: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
KW - Cervical cancer
KW - Cervical intraepithelial neoplasia (CIN)
KW - HPV
KW - Persistent infection
KW - Vaccine
KW - Vulvar intraepithelial neoplasia (VIN)
UR - http://www.scopus.com/inward/record.url?scp=85064037417&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064037417&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2019.03.253
DO - 10.1016/j.ygyno.2019.03.253
M3 - Article
C2 - 30982556
AN - SCOPUS:85064037417
SN - 0090-8258
VL - 154
SP - 110
EP - 117
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 1
ER -