human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic , generally well tolerated , and effective against HPV-16 or HPV-18 infections , and associated precancerous lesions in an event-triggered interim analysis of the phase III r and omised , double-blind , controlled PApilloma TRIal against Cancer In young Adults ( PATRICIA ) . We now assess the vaccine efficacy in the final event-driven analysis . METHODS Women ( 15 - 25 years ) were vaccinated at months 0 , 1 , and 6 . Analyses were done in the according-to- protocol cohort for efficacy ( ATP-E ; vaccine , n=8093 ; control , n=8069 ) , total vaccinated cohort ( TVC , included all women receiving at least one vaccine dose , regardless of their baseline HPV status ; represents the general population , including those who are sexually active ; vaccine , n=9319 ; control , n=9325 ) , and TVC-naive ( no evidence of oncogenic HPV infection at baseline ; represents women before sexual debut ; vaccine , n=5822 ; control , n=5819 ) . The primary endpoint was to assess vaccine efficacy against cervical intraepithelial neoplasia 2 + ( CIN2 + ) that was associated with HPV-16 or HPV-18 in women who were seronegative at baseline , and DNA negative at baseline and month 6 for the corresponding type ( ATP-E ) . This trial is registered with Clinical Trials.gov , number NCT00122681 . FINDINGS Mean follow-up was 34.9 months ( SD 6.4 ) after the third dose . Vaccine efficacy against CIN2 + associated with HPV-16/18 was 92.9 % ( 96.1 % CI 79.9 - 98.3 ) in the primary analysis and 98.1 % ( 88.4 - 100 ) in an analysis in which probable causality to HPV type was assigned in lesions infected with multiple oncogenic types ( ATP-E cohort ) . Vaccine efficacy against CIN2 + irrespective of HPV DNA in lesions was 30.4 % ( 16.4 - 42.1 ) in the TVC and 70.2 % ( 54.7 - 80.9 ) in the TVC-naive . Corresponding values against CIN3 + were 33.4 % ( 9.1 - 51.5 ) in the TVC and 87.0 % ( 54.9 - 97.7 ) in the TVC-naive . Vaccine efficacy against CIN2 + associated with 12 non-vaccine oncogenic types was 54.0 % ( 34.0 - 68.4 ; ATP-E ) . Individual cross-protection against CIN2 + associated with HPV-31 , HPV-33 , and HPV-45 was seen in the TVC . INTERPRETATION The HPV-16/18 AS04-adjuvanted vaccine showed high efficacy against CIN2 + associated with HPV-16/18 and non-vaccine oncogenic HPV types and substantial overall effect in cohorts that are relevant to universal mass vaccination and catch-up programmes . FUNDING GlaxoSmithKline Biologicals BACKGROUND Although the peak incidence of human papillomavirus ( HPV ) infection occurs in most population s within 5 - 10 years of first sexual experience , all women remain at risk for acquisition of HPV infections . We tested the safety , immunogenicity , and efficacy of the quadrivalent HPV ( types 6 , 11 , 16 , 18 ) L1 virus-like-particle vaccine in women aged 24 - 45 years . METHODS Women aged 24 - 45 years with no history of genital warts or cervical disease were enrolled from community health centres , academic health centres , and primary health-care providers into an ongoing multicentre , parallel , r and omised , placebo-controlled , double-blind study . Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine ( n=1911 ) or placebo ( n=1908 ) at day 1 , and months 2 and 6 . All study site investigators and personnel , study participants , monitors , and central laboratory personnel were blinded to treatment allocation . Co primary efficacy endpoints were 6 months ' or more duration of infection and cervical and external genital disease due to HPV 6 , 11 , 16 , 18 ; and due to HPV 16 and 18 alone . Primary efficacy analyses were done in a per- protocol population , but intention-to-treat analyses were also undertaken . This study is registered with Clinical Trials.gov , number NCT00090220 . FINDINGS 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo . In the per- protocol population , efficacy against the first co primary endpoint ( disease or infection related to HPV 6 , 11 , 16 , and 18 ) was 90.5 % ( 95 % CI 73.7 - 97.5 , four of 1615 cases in the vaccine group vs 41/1607 in the placebo group ) and 83.1 % ( 50.6 - 95.8 , four of 1601 cases vs 23/1579 cases ) against the second co primary endpoint ( disease or infection related to HPV 16 and 18 alone ) . In the intention-to-treat population , efficacy against the first co primary endpoint was 30.9 % ( 95 % CI 11.1 - 46.5 , 108/1886 cases vs 154/1883 cases ) and against the second co primary endpoint was 22.6 % ( -2.9 to 41.9 , 90/1886 cases vs 115/1883 cases ) , since infection and disease were present at baseline . We recorded no vaccine-related serious adverse events . INTERPRETATION The quadrivalent HPV vaccine is efficacious in women aged 24 - 45 years not infected with the relevant HPV types at enrolment . FUNDING Merck ( USA ) Background : Previous analyses from a r and omised trial in women aged 24–45 years have shown the quadrivalent human papillomavirus ( qHPV ) vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( CIN ) , and external genital lesions ( EGLs ) related to HPV 6/11/16/18 . In this report , we present end-of- study efficacy , safety , and immunogenicity data with a median follow-up time of 4.0 years . Methods : We enrolled 3819 24–45-year-old women with no history of cervical disease or genital warts in the past 5 years . Women received quadrivalent vaccine or placebo at day 1 , and at months 2 and 6 . Ascertainment of CIN/EGL was accomplished through Pap testing , genital inspection , and cervicovaginal sampling ( every 6 months ) . The main analysis was conducted in a per- protocol efficacy population ( that received three doses , was naive to the relevant HPV types at day 1 , and remained free of infection through month 7 ) . Efficacy was also estimated in other naive and non-naive population s. Results : Vaccine efficacy against the combined incidence of persistent infection , CIN/EGL related to HPV6/11/16/18 in the per- protocol population was 88.7 % ( 95 % CI : 78.1 , 94.8 ) . Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9 % ( 95 % CI : 4.3 , 90.6 ) . At month 48 , 91.5 , 92.0 , 97.4 , and 47.9 % of vaccinated women were seropositive to HPV 6/11/16/18 , respectively . No serious vaccine-related adverse experiences were reported . Conclusions : The qHPV vaccine demonstrated high efficacy , immunogenicity , and acceptable safety in women aged 24–45 years , regardless of previous exposure to HPV vaccine type BACKGROUND A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus ( HPV ) types 6 , 11 , 16 , and 18 . METHODS In this r and omized , placebo-controlled , double-blind trial involving 5455 women between the ages of 16 and 24 years , we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1 , month 2 , and month 6 . The co primary composite end points were the incidence of genital warts , vulvar or vaginal intraepithelial neoplasia , or cancer and the incidence of cervical intraepithelial neoplasia , adenocarcinoma in situ , or cancer associated with HPV type 6 , 11 , 16 , or 18 . Data for the primary analysis were collected for a per- protocol susceptible population of women who had no virologic evidence of HPV type 6 , 11 , 16 , or 18 through 1 month after administration of the third dose . RESULTS The women were followed for an average of 3 years after administration of the first dose . In the per- protocol population , those followed for vulvar , vaginal , or perianal disease included 2261 women ( 83 % ) in the vaccine group and 2279 ( 83 % ) in the placebo group . Those followed for cervical disease included 2241 women ( 82 % ) in the vaccine group and 2258 ( 83 % ) in the placebo group . Vaccine efficacy was 100 % for each of the co primary end points . In an intention-to-treat analysis , including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV , vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34 % ( 95 % confidence interval [ CI ] , 15 to 49 ) , and the rate of cervical lesions regardless of the causal HPV type by 20 % ( 95 % CI , 8 to 31 ) . CONCLUSIONS The quadrivalent vaccine significantly reduced the incidence of  HPV-associated anogenital diseases in young women . ( Clinical Trials.gov number , NCT00092521 [ Clinical Trials.gov ] . ) To investigate the prevalence of and the risk factors for human papillomavirus ( HPV ) infection in South Korea , we interviewed and examined a r and omly selected sample of 863 sexually active women ( age range = 20 - 74 years , median 44 ) and 103 self-reported virgins from Busan . The presence of DNA of 34 different HPV types in cervical exfoliated cells was tested among sexually active women by means of a PCR-based assay .  IgG antibodies against L1 virus-like particles ( anti-VLPs ) of HPV types 16 , 18 , 31 , 33 and 58 were also evaluated by means of ELISA . The overall prevalence of HPV DNA was 10.4 % ( 95 % confidence interval , CI : 8.5 - 12.7 % ) . The most often found HPV DNA types were HPV 70 , HPV 16 and HPV 33 ; 19.8 % ( 95 % CI : 17.2 - 22.0 ) of sexually active women had antibodies against one or more HPV types . The most common anti-VLPs were against HPV 18 , 31 and 16 . Prevalences st and ardized by age on the basis of the world st and ard population were 13.0 % for HPV DNA and 17.1 % for anti-VLPs . The concordance between the 2 HPV markers at an individual level was modest , but the risk factors for detection of HPV DNA and anti-VLPs were similar : number of lifetime sexual partners ( odds ratio , OR for > /= 4 vs. 1 = 3.5 and 5.4 , respectively ) , seropositivity for herpes simplex virus-2 antibodies ( OR = 2.6 and 2.5 , respectively ) and being single or divorced . HPV DNA , but not anti-VLPs , were elevated among women whose husb and s were thought by their wives to have extra-marital affairs and those who had undergone vasectomy . Among 103 virgins , 4.9 % had anti-VLPs ( 1/73 among those aged 24 years or less ) Objectives To determine the effect of human papillomavirus ( HPV ) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts , vulvar intraepithelial neoplasia , or vaginal intraepithel 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic , generally well tolerated , and effective against HPV-16 or HPV-18 infections , and associated precancerous lesions in an event-triggered interim analysis of the phase III r and omised , double-blind , controlled PApilloma TRIal against Cancer In young Adults ( PATRICIA ) . We now assess the vaccine efficacy in the final event-driven analysis . METHODS Women ( 15 - 25 years ) were vaccinated at months 0 , 1 , and 6 . Analyses were done in the according-to- protocol cohort for efficacy ( ATP-E ; vaccine , n=8093 ; control , n=8069 ) , total vaccinated cohort ( TVC , included all women receiving at least one vaccine dose , regardless of their baseline HPV status ; represents the general population , including those who are sexually active ; vaccine , n=9319 ; control , n=9325 ) , and TVC-naive ( no evidence of oncogenic HPV infection at baseline ; represents women before sexual debut ; vaccine , n=5822 ; control , n=5819 ) . The primary endpoint was to assess vaccine efficacy against cervical intraepithelial neoplasia 2 + ( CIN2 + ) that was associated with HPV-16 or HPV-18 in women who were seronegative at baseline , and DNA negative at baseline and month 6 for the corresponding type ( ATP-E ) . This trial is registered with Clinical Trials.gov , number NCT00122681 . FINDINGS Mean follow-up was 34.9 months ( SD 6.4 ) after the third dose . Vaccine efficacy against CIN2 + associated with HPV-16/18 was 92.9 % ( 96.1 % CI 79.9 - 98.3 ) in the primary analysis and 98.1 % ( 88.4 - 100 ) in an analysis in which probable causality to HPV type was assigned in lesions infected with multiple oncogenic types ( ATP-E cohort ) . Vaccine efficacy against CIN2 + irrespective of HPV DNA in lesions was 30.4 % ( 16.4 - 42.1 ) in the TVC and 70.2 % ( 54.7 - 80.9 ) in the TVC-naive . Corresponding values against CIN3 + were 33.4 % ( 9.1 - 51.5 ) in the TVC and 87.0 % ( 54.9 - 97.7 ) in the TVC-naive . Vaccine efficacy against CIN2 + associated with 12 non-vaccine oncogenic types was 54.0 % ( 34.0 - 68.4 ; ATP-E ) . Individual cross-protection against CIN2 + associated with HPV-31 , HPV-33 , and HPV-45 was seen in the TVC . INTERPRETATION The HPV-16/18 AS04-adjuvanted vaccine showed high efficacy against CIN2 + associated with HPV-16/18 and non-vaccine oncogenic HPV types and substantial overall effect in cohorts that are relevant to universal mass vaccination and catch-up programmes . FUNDING GlaxoSmithKline Biologicals BACKGROUND Although the peak incidence of human papillomavirus ( HPV ) infection occurs in most population s within 5 - 10 years of first sexual experience , all women remain at risk for acquisition of HPV infections . We tested the safety , immunogenicity , and efficacy of the quadrivalent HPV ( types 6 , 11 , 16 , 18 ) L1 virus-like-particle vaccine in women aged 24 - 45 years . METHODS Women aged 24 - 45 years with no history of genital warts or cervical disease were enrolled from community health centres , academic health centres , and primary health-care providers into an ongoing multicentre , parallel , r and omised , placebo-controlled , double-blind study . Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine ( n=1911 ) or placebo ( n=1908 ) at day 1 , and months 2 and 6 . All study site investigators and personnel , study participants , monitors , and central laboratory personnel were blinded to treatment allocation . Co primary efficacy endpoints were 6 months ' or more duration of infection and cervical and external genital disease due to HPV 6 , 11 , 16 , 18 ; and due to HPV 16 and 18 alone . Primary efficacy analyses were done in a per- protocol population , but intention-to-treat analyses were also undertaken . This study is registered with Clinical Trials.gov , number NCT00090220 . FINDINGS 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo . In the per- protocol population , efficacy against the first co primary endpoint ( disease or infection related to HPV 6 , 11 , 16 , and 18 ) was 90.5 % ( 95 % CI 73.7 - 97.5 , four of 1615 cases in the vaccine group vs 41/1607 in the placebo group ) and 83.1 % ( 50.6 - 95.8 , four of 1601 cases vs 23/1579 cases ) against the second co primary endpoint ( disease or infection related to HPV 16 and 18 alone ) . In the intention-to-treat population , efficacy against the first co primary endpoint was 30.9 % ( 95 % CI 11.1 - 46.5 , 108/1886 cases vs 154/1883 cases ) and against the second co primary endpoint was 22.6 % ( -2.9 to 41.9 , 90/1886 cases vs 115/1883 cases ) , since infection and disease were present at baseline . We recorded no vaccine-related serious adverse events . INTERPRETATION The quadrivalent HPV vaccine is efficacious in women aged 24 - 45 years not infected with the relevant HPV types at enrolment . FUNDING Merck ( USA ) Background : Previous analyses from a r and omised trial in women aged 24–45 years have shown the quadrivalent human papillomavirus ( qHPV ) vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( CIN ) , and external genital lesions ( EGLs ) related to HPV 6/11/16/18 . In this report , we present end-of- study efficacy , safety , and immunogenicity data with a median follow-up time of 4.0 years . Methods : We enrolled 3819 24–45-year-old women with no history of cervical disease or genital warts in the past 5 years . Women received quadrivalent vaccine or placebo at day 1 , and at months 2 and 6 . Ascertainment of CIN/EGL was accomplished through Pap testing , genital inspection , and cervicovaginal sampling ( every 6 months ) . The main analysis was conducted in a per- protocol efficacy population ( that received three doses , was naive to the relevant HPV types at day 1 , and remained free of infection through month 7 ) . Efficacy was also estimated in other naive and non-naive population s. Results : Vaccine efficacy against the combined incidence of persistent infection , CIN/EGL related to HPV6/11/16/18 in the per- protocol population was 88.7 % ( 95 % CI : 78.1 , 94.8 ) . Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9 % ( 95 % CI : 4.3 , 90.6 ) . At month 48 , 91.5 , 92.0 , 97.4 , and 47.9 % of vaccinated women were seropositive to HPV 6/11/16/18 , respectively . No serious vaccine-related adverse experiences were reported . Conclusions : The qHPV vaccine demonstrated high efficacy , immunogenicity , and acceptable safety in women aged 24–45 years , regardless of previous exposure to HPV vaccine type BACKGROUND A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus ( HPV ) types 6 , 11 , 16 , and 18 . METHODS In this r and omized , placebo-controlled , double-blind trial involving 5455 women between the ages of 16 and 24 years , we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1 , month 2 , and month 6 . The co primary composite end points were the incidence of genital warts , vulvar or vaginal intraepithelial neoplasia , or cancer and the incidence of cervical intraepithelial neoplasia , adenocarcinoma in situ , or cancer associated with HPV type 6 , 11 , 16 , or 18 . Data for the primary analysis were collected for a per- protocol susceptible population of women who had no virologic evidence of HPV type 6 , 11 , 16 , or 18 through 1 month after administration of the third dose . RESULTS The women were followed for an average of 3 years after administration of the first dose . In the per- protocol population , those followed for vulvar , vaginal , or perianal disease included 2261 women ( 83 % ) in the vaccine group and 2279 ( 83 % ) in the placebo group . Those followed for cervical disease included 2241 women ( 82 % ) in the vaccine group and 2258 ( 83 % ) in the placebo group . Vaccine efficacy was 100 % for each of the co primary end points . In an intention-to-treat analysis , including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV , vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34 % ( 95 % confidence interval [ CI ] , 15 to 49 ) , and the rate of cervical lesions regardless of the causal HPV type by 20 % ( 95 % CI , 8 to 31 ) . CONCLUSIONS The quadrivalent vaccine significantly reduced the incidence of  HPV-associated anogenital diseases in young women . ( Clinical Trials.gov number , NCT00092521 [ Clinical Trials.gov ] . ) To investigate the prevalence of and the risk factors for human papillomavirus ( HPV ) infection in South Korea , we interviewed and examined a r and omly selected sample of 863 sexually active women ( age range = 20 - 74 years , median 44 ) and 103 self-reported virgins from Busan . The presence of DNA of 34 different HPV types in cervical exfoliated cells was tested among sexually active women by means of a PCR-based assay .  IgG antibodies against L1 virus-like particles ( anti-VLPs ) of HPV types 16 , 18 , 31 , 33 and 58 were also evaluated by means of ELISA . The overall prevalence of HPV DNA was 10.4 % ( 95 % confidence interval , CI : 8.5 - 12.7 % ) . The most often found HPV DNA types were HPV 70 , HPV 16 and HPV 33 ; 19.8 % ( 95 % CI : 17.2 - 22.0 ) of sexually active women had antibodies against one or more HPV types . The most common anti-VLPs were against HPV 18 , 31 and 16 . Prevalences st and ardized by age on the basis of the world st and ard population were 13.0 % for HPV DNA and 17.1 % for anti-VLPs . The concordance between the 2 HPV markers at an individual level was modest , but the risk factors for detection of HPV DNA and anti-VLPs were similar : number of lifetime sexual partners ( odds ratio , OR for > /= 4 vs. 1 = 3.5 and 5.4 , respectively ) , seropositivity for herpes simplex virus-2 antibodies ( OR = 2.6 and 2.5 , respectively ) and being single or divorced . HPV DNA , but not anti-VLPs , were elevated among women whose husb and s were thought by their wives to have extra-marital affairs and those who had undergone vasectomy . Among 103 virgins , 4.9 % had anti-VLPs ( 1/73 among those aged 24 years or less ) Objectives To determine the effect of human papillomavirus ( HPV ) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts , vulvar intraepithelial neoplasia , or vaginal intraepithel 
    Output:
    