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 - Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2019/7/1
Y1 - 2019/7/1
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 - Adult
KW - DNA, Viral/isolation & purification
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Papillomaviridae/genetics
KW - Papillomavirus Infections/pathology
KW - Papillomavirus Vaccines/administration & dosage
KW - Uterine Cervical Dysplasia/pathology
KW - Vaginal Diseases/pathology
KW - Vulvar Diseases/pathology
KW - Young Adult
KW - Vulvar intraepithelial neoplasia (VIN)
KW - Vaccine
KW - HPV
KW - Cervical intraepithelial neoplasia (CIN)
KW - Persistent infection
KW - Cervical cancer
UR - http://www.scopus.com/inward/record.url?scp=85064037417&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2019.03.253
DO - 10.1016/j.ygyno.2019.03.253
M3 - Journal article
C2 - 30982556
SN - 0090-8258
VL - 154
SP - 110
EP - 117
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 1
ER -