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Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population.
- Source :
-
Gynecologic oncology [Gynecol Oncol] 2019 Jul; Vol. 154 (1), pp. 110-117. Date of Electronic Publication: 2019 Apr 11. - Publication Year :
- 2019
-
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).<br />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.<br />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.<br />Conclusions: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures.<br />Trial Registrations: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.<br /> (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
DNA, Viral isolation & purification
Double-Blind Method
Female
Humans
Papillomaviridae genetics
Papillomaviridae immunology
Papillomavirus Infections pathology
Papillomavirus Vaccines adverse effects
Papillomavirus Vaccines immunology
Uterine Cervical Dysplasia pathology
Uterine Cervical Dysplasia surgery
Uterine Cervical Dysplasia virology
Vaginal Diseases pathology
Vaginal Diseases virology
Vulvar Diseases pathology
Vulvar Diseases virology
Young Adult
Papillomavirus Infections prevention & control
Papillomavirus Vaccines administration & dosage
Uterine Cervical Dysplasia prevention & control
Vaginal Diseases prevention & control
Vulvar Diseases prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1095-6859
- Volume :
- 154
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gynecologic oncology
- Publication Type :
- Academic Journal
- Accession number :
- 30982556
- Full Text :
- https://doi.org/10.1016/j.ygyno.2019.03.253