Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population

Anna R. Giuliano, Elmar A. Joura, Suzanne M. Garland, Warner K. Huh, Ole Erik Iversen, Susanne K. Kjaer, Alex Ferenczy, Robert J Kurman, Brigitte Maria Ronnett, Mark H. Stoler, Oliver M. Bautista, Erin Moeller, Michael Ritter, Christine Shields, Alain Luxembourg

Research output: Contribution to journalArticle

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 languageEnglish (US)
JournalGynecologic oncology
DOIs
StatePublished - Jan 1 2019

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Papillomavirus Vaccines
Vaccines
Placebos
Population
Therapeutics
Vaginal Diseases
Vulvar Diseases
Confidence Intervals
Double-Blind Method
Vaccination
Biopsy
DNA
Incidence

Keywords

  • Cervical cancer
  • Cervical intraepithelial neoplasia (CIN)
  • HPV
  • Persistent infection
  • Vaccine
  • Vulvar intraepithelial neoplasia (VIN)

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Nine-valent HPV vaccine efficacy against related diseases and definitive therapy : comparison with historic placebo population. / Giuliano, Anna R.; Joura, Elmar A.; Garland, Suzanne M.; Huh, Warner K.; Iversen, Ole Erik; Kjaer, Susanne K.; Ferenczy, Alex; Kurman, Robert J; Ronnett, Brigitte Maria; Stoler, Mark H.; Bautista, Oliver M.; Moeller, Erin; Ritter, Michael; Shields, Christine; Luxembourg, Alain.

In: Gynecologic oncology, 01.01.2019.

Research output: Contribution to journalArticle

Giuliano, AR, Joura, EA, Garland, SM, Huh, WK, Iversen, OE, Kjaer, SK, Ferenczy, A, Kurman, RJ, Ronnett, BM, Stoler, MH, Bautista, OM, Moeller, E, Ritter, M, Shields, C & Luxembourg, A 2019, 'Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population', Gynecologic oncology. https://doi.org/10.1016/j.ygyno.2019.03.253
Giuliano, Anna R. ; Joura, Elmar A. ; Garland, Suzanne M. ; Huh, Warner K. ; Iversen, Ole Erik ; Kjaer, Susanne K. ; Ferenczy, Alex ; Kurman, Robert J ; Ronnett, Brigitte Maria ; Stoler, Mark H. ; Bautista, Oliver M. ; Moeller, Erin ; Ritter, Michael ; Shields, Christine ; Luxembourg, Alain. / Nine-valent HPV vaccine efficacy against related diseases and definitive therapy : comparison with historic placebo population. In: Gynecologic oncology. 2019.
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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.",
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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 Maria

AU - Stoler, Mark H.

AU - Bautista, Oliver M.

AU - Moeller, Erin

AU - Ritter, Michael

AU - Shields, Christine

AU - Luxembourg, Alain

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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.

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KW - Cervical cancer

KW - Cervical intraepithelial neoplasia (CIN)

KW - HPV

KW - Persistent infection

KW - Vaccine

KW - Vulvar intraepithelial neoplasia (VIN)

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