Long-Term Follow-up Observation of the Safety, Immunogenicity, and Effectiveness of Gardasil™ in Adult Women

Abstract

BackgroundPrevious 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.ResultsThere 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.ConclusionsVaccination 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.gov NCT00090220

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

“…Younger individuals have higher GMTs induced by the vaccine, which is why we used the 35–45 year old age group to compare point estimates of post vaccine GMTs since our cohort mean age was 38.1 years. 18-21 The kinetics of antibody response to qHPV vaccine show a peak one month after the third vaccine shot and a decrease in level to a plateau at 18 months, with high GMTs maintained at 5 years post vaccine. 18 , 20-22 There are some studies assessing immunogenicity in immunosuppressed populations with most showing immunogenicity with slightly lower GMTs post vaccine than in normal individuals.…”

Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes

“…This reduction of seropositivity for HPV18 by cLIA is consistent with findings in aprevious study in Colombia, which reported a 45% of seropositivity for HPV18 at month 72, nevertheless a sustained absence of disease due to HPV18, as well as due to the other HPV vaccine types was observed. 32 However, when the total IgG assay is used, the proportion of women who are seropositive for HPV18 at month 72 is substantially higher (81.5% overall). The high seronegativity rate for HPV18 deserves further evaluation to better understand the long term protection of less than 3 doses schedule.…”

HPV vaccination impact on a cervical cancer screening program: methods of the FASTER-Tlalpan Study in Mexico

“…11,12 Additionally, current vaccines protect against both HPV16 and HPV18 as well as provide cross-protection against other HPV types, particularly types 31 and 45. 13 Broadspectrum protection such as this may lower the need for subsequent screening, warrant longer screening intervals than those currently used, and offer novel prevention policies against HPV-related cancers.…”

“…11,12 The aim of the present study is to document the benefit of a massive HPV vaccination program within a cervical cancer-screening program to extend the HPV screening interval from five to 10 years through the prevention of 6-month persistent infection as well as the prevention of CIN2+ incidence.…”