{"entity":{"id":"patricia","kind":"trial","name":"PATRICIA","aka":["HPV-008","HPV 008","PApilloma TRIal against Cancer In young Adults","580299/008"],"tldr":"PATRICIA showed that three doses of a vaccine against the two human papillomavirus types behind most cervical cancers prevented almost all of the type-specific high-grade cervical precancers in young women who were free of those types when vaccinated, which carried Cervarix to approval in Europe and the United States.","summary":"PATRICIA (PApilloma TRIal against Cancer In young Adults; Cervarix product information study HPV-008; NCT00122681) was a multinational, double-blind, randomised, controlled phase 3 trial of the HPV-16/18 AS04-adjuvanted vaccine in women aged 15 to 25 years. Women received the HPV vaccine or a hepatitis A vaccine control at months 0, 1 and 6.\n\nThe primary endpoint was vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV-16 or HPV-18 in the according-to-protocol cohort for efficacy (women seronegative at baseline and DNA negative at baseline and month 6 for the corresponding type; vaccine 8,093, control 8,069). In the Lancet 2009 final event-driven analysis, after a mean follow-up of 34.9 months from the third dose, vaccine efficacy was 92.9 percent (96.1 percent CI 79.9 to 98.3) in the primary analysis and 98.1 percent (88.4 to 100) when probable causality to HPV type was assigned in lesions infected with several oncogenic types. Efficacy against CIN2+ irrespective of HPV type was 30.4 percent in the total vaccinated cohort and 70.2 percent in women with no evidence of oncogenic HPV infection at baseline, and cross-protection against CIN2+ associated with HPV-31, HPV-33 and HPV-45 was seen.\n\nThe Cervarix product information names the study HPV-008 and quotes the same 92.9 percent event-triggered figure. ClinicalTrials.gov registers the trial with condition papillomavirus infection rather than a cancer, which is why the automated pass never attached it to the vaccine record.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00122681","url":"https://clinicaltrials.gov/study/NCT00122681"},{"label":"Lancet 2009","url":"https://doi.org/10.1016/S0140-6736(09)61248-4"},{"label":"Cervarix EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cervarix"}],"tags":[],"related":[],"cancers":["cervical"],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":["hpv-bivalent-vaccine"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-patricia-paavonen-lancet-2009"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00122681","phase":"3","setting":"Women aged 15 to 25 years: HPV-16/18 AS04-adjuvanted vaccine versus hepatitis A vaccine control at months 0, 1 and 6, for prevention of cervical precancer associated with HPV-16 or HPV-18","sponsor":"GlaxoSmithKline","result":"Vaccine efficacy against CIN2+ associated with HPV-16/18 92.9% (96.1% CI 79.9 to 98.3) in the according-to-protocol efficacy cohort; 98.1% with HPV-type causality assigned.","yearReported":2009,"enrolled":18644,"enrolledBasis":"randomised","enrolledNote":"The Lancet 2009 final analysis reports a total vaccinated cohort of 9,319 women on the HPV-16/18 vaccine and 9,325 on the hepatitis A control (18,644); ClinicalTrials.gov NCT00122681 lists an actual enrolment of 18,729.","outcomes":[{"endpoint":"Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (according-to-protocol cohort for efficacy, primary analysis)","primary":true,"unit":"%","arms":[{"name":"HPV-16/18 AS04-adjuvanted vaccine","n":8093,"value":92.9,"note":"96.1% confidence interval 79.9 to 98.3; efficacy is relative to the control arm"},{"name":"Hepatitis A vaccine control","n":8069,"note":"Reference arm; the abstract reports efficacy, not a control-arm rate"}],"ci":[79.9,98.3],"source":"https://doi.org/10.1016/S0140-6736(09)61248-4"},{"endpoint":"Vaccine efficacy against CIN2+ irrespective of HPV type (total vaccinated cohort, no evidence of oncogenic HPV at baseline)","unit":"%","arms":[{"name":"HPV-16/18 AS04-adjuvanted vaccine","n":5822,"value":70.2,"note":"96.1% confidence interval 54.7 to 80.9"},{"name":"Hepatitis A vaccine control","n":5819}],"ci":[54.7,80.9],"source":"https://doi.org/10.1016/S0140-6736(09)61248-4"}],"replication":"FUTURE I and II established the same class effect for the quadrivalent vaccine; the Costa Rica Vaccine Trial and KEN SHE later showed that one dose of an HPV vaccine protects as well as two or three."},"route":"/trials/patricia/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}],"section":[{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"hpv-vaccine","kind":"technology","name":"HPV & HBV vaccination","route":"/technologies/hpv-vaccine/"}],"drug":[{"id":"hpv-bivalent-vaccine","kind":"drug","name":"HPV bivalent vaccine (types 16 and 18)","route":"/drugs/hpv-bivalent-vaccine/"}],"company":[{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"}],"paper":[{"id":"paper-patricia-paavonen-lancet-2009","kind":"paper","name":"Efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis","route":"/key-papers/paper-patricia-paavonen-lancet-2009/"}]}}