PloS one · 2013
Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Luna Joaquin, Plata Manuel, Gonzalez Mauricio, Correa Alfonso, Maldonado Ivete, Nossa Claudia, Radley David, Vuocolo Scott, Haupt Richard M, Saah Alfred
Аннотация
BACKGROUND: Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.
METHODS: Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.
RESULTS: There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.
CONCLUSIONS: Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.
TRIAL REGISTRATION: Clinicaltrials.govNCT00090220.
METHODS: Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.
RESULTS: There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.
CONCLUSIONS: Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.
TRIAL REGISTRATION: Clinicaltrials.govNCT00090220.
Предметные рубрики MeSH
AdultColombiaCondylomata AcuminataDouble-Blind MethodFemaleFollow-Up StudiesHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Human papillomavirus 11Human papillomavirus 16Human papillomavirus 18Human papillomavirus 6HumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesPregnancySafetyTreatment OutcomeUterine Cervical NeoplasmsYoung AdultUterine Cervical Dysplasia