17 research outputs found
Prior human papillomavirusâ16/18 AS04âadjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Postâhoc analysis from a randomized controlled trial
We evaluated the efficacy of the human papillomavirus (HPV)â16/18 AS04âadjuvanted vaccine in preventing HPVârelated disease after surgery for cervical lesions in a postâhoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15â25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPVâ16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present postâhoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPVârelated cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more postâsurgery. Other outcomes included the incidence of HPVârelated CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more postâsurgery. Of the total vaccinated cohort of 18,644 women (vaccineâ=â9,319; controlâ=â9,325), 454 (vaccineâ=â190, controlâ=â264) underwent an excisional procedure during the trial. Efficacy 60 days or more postâsurgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (â21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more postâsurgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPVâ16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.139122812282
Risk of newly detected infections and cervical abnormalities in adult women seropositive or seronegative for naturally acquired HPV-16/18 antibodies
Funder: GlaxoSmithKline Biologicals SAPeer reviewedPublisher PD
Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial
We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccineâ=â9,319; controlâ=â9,325), 454 (vaccineâ=â190, controlâ=â264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.status: publishe
Risk of newly detected infections and cervical abnormalities in adult women seropositive or seronegative for naturally acquired HPV-16/18 antibodies
10.1002/cam4.1879CANCER MEDICINE8104938-495
Risk of newly detected infections and cervical abnormalities in adult women seropositive or seronegative for naturally acquired HPVâ16/18 antibodies
Abstract Background Infections with human papillomavirus (HPV) types 16 and 18 account for ~70% of invasive cervical cancers but the degree of protection from naturally acquired antiâHPV antibodies is uncertain. We examined the risk of HPV infections as defined by HPV DNA detection and cervical abnormalities among women >25Â years in the Human Papilloma VIrus Vaccine Immunogenicity ANd Efficacy trial's (VIVIANE, NCT00294047) control arm. Methods Serum antiâHPVâ16/18 antibodies were determined at baseline and every 12Â months in baseline DNAânegative women (NÂ =Â 2687 for HPVâ16 and 2705 for HPVâ18) by enzymeâlinked immunosorbent assay (ELISA) from blood samples. HPV infections were identified by polymerase chain reaction (PCR) every 6âmonths, and cervical abnormalities were confirmed by cytology every 12Â months. Data were collected over a 7âyear period. The association between the risk of typeâspecific infection and cervical abnormalities and serostatus was assessed using Cox proportional hazard models. Results Risk of newly detected HPVâ16âassociated 6âmonth persistent infections (PI) (hazard ratio [HR]Â =Â 0.56 [95%CI:0.32; 0.99]) and atypical squamous cells of undetermined significance (ASCâUS+) (HRÂ =Â 0.28 [0.12; 0.67]) were significantly lower in baseline seropositive vs baseline seronegative women. HPVâ16âassociated incident infections (HRÂ =Â 0.81 [0.56; 1.16]) and 12âmonth PI (HRÂ =Â 0.53 [0.24; 1.16]) showed the same trend. A similar trend of lower risk was observed in HPVâ18âseropositive vs âseronegative women (HRÂ =Â 0.95 [0.59; 1.51] for IIs, HRÂ =Â 0.43 [0.16; 1.13] for 6âmonth PIs, HRÂ =Â 0.31 [0.07; 1.36] for 12âmonth PIs, and HRÂ =Â 0.61 [0.23; 1.61] for ASCâUS+). Conclusions Naturally acquired antiâHPVâ16 antibodies were associated with a decreased risk of subsequent infection and cervical abnormalities in women >25Â years. This possible protection was lower than that previously reported in 15â to 25âyearâold women