{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T11:13:21Z","timestamp":1790162001318,"version":"4.1.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"8","funder":[{"name":"The Costa Rica HPV Vaccine Trial","award":["NCT00128661"],"award-info":[{"award-number":["NCT00128661"]}]},{"DOI":"10.13039\/100000054","name":"NCI","doi-asserted-by":"publisher","award":["N01-CP-11005"],"award-info":[{"award-number":["N01-CP-11005"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institutes of Health Office of Research on Women's Health","award":["FDA BB-IND 7920"],"award-info":[{"award-number":["FDA BB-IND 7920"]}]},{"name":"PATRICIA","award":["NCT00122681"],"award-info":[{"award-number":["NCT00122681"]}]},{"name":"GlaxoSmithKline Biologicals SA"},{"DOI":"10.13039\/100000054","name":"NCI","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"name":"GlaxoSmithKline Biologicals SA","award":["205206"],"award-info":[{"award-number":["205206"]}]},{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The AS04-adjuvanted HPV16\/18 (AS04-HPV16\/18) vaccine provides excellent protection against targeted human papillomavirus (HPV) types and a variable degree of cross-protection against others, including types 6\/11\/31\/33\/45. High efficacy against any cervical intraepithelial neoplasia grade 3 or greater (CIN3+; &amp;gt;90%) suggests that lower levels of protection may exist for a wide range of oncogenic HPV types, which is difficult to quantify in individual trials. Pooling individual-level data from two randomized controlled trials, we aimed to evaluate AS04-HPV16\/18 vaccine efficacy against incident HPV infections and cervical abnormalities .<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data were available from the Costa Rica Vaccine Trial (NCT00128661) and Papilloma Trial Against Cancer in Young Adults trial (NCT00122681), two large-scale, double-blind randomized controlled trials of the AS04-HPV16\/18 vaccine. Primary analyses focused on disease-free women with no detectable cervicovaginal HPV at baseline.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 12\u2009550 women were included in our primary analyses (HPV arm\u2009=\u20096271, control arm\u2009=\u20096279). Incidence of 6-month persistent oncogenic and nononcogenic infections, excluding known and accepted protected types 6\/11\/16\/18\/31\/33\/45 (focusing on 34\/35\/39\/40\/42\/43\/44\/51\/52\/53\/54\/56\/58\/59\/66\/68\/73\/70\/74), was statistically significantly lower in the HPV arm than in the control arm (efficacy\u2009=\u20099.9%, 95% confidence interval [CI] = 1.7% to 17.4%). Statistically significant efficacy (P\u2009&amp;lt;\u2009.05) was observed for individual oncogenic types 16\/18\/31\/33\/45\/52 and nononcogenic types 6\/11\/53\/74. Efficacy against cervical abnormalities (all types) increased with severity, ranging from 27.7% (95% CI = 21.7% to 33.3%) to 58.7% (95% CI = 34.1% to 74.7%) for cytologic outcomes (low-grade squamous intraepithelial neoplasia lesion or greater, and high-grade squamous intraepithelial neoplasia lesion or greater, respectively) and 66.0% (95% CI = 54.4% to 74.9%) to 87.8% (95% CI = 71.1% to 95.7%) for histologic outcomes (CIN2+ and CIN3+, respectively). Comparing Costa Rica Vaccine Trial and Papilloma Trial Against Cancer in Young Adults results, there was no evidence of heterogeneity, except for type 51 (efficacy = \u221228.6% and 20.7%, respectively; two-sided P\u2009=\u2009.03).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The AS04-HPV16\/18 vaccine provides some additional cross-protection beyond established protected types, which partially explains the high efficacy against CIN3+.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jnci\/djz222","type":"journal-article","created":{"date-parts":[[2019,11,5]],"date-time":"2019-11-05T04:56:20Z","timestamp":1572929780000},"page":"818-828","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy of the AS04-Adjuvanted HPV16\/18 Vaccine: Pooled Analysis of the Costa Rica Vaccine and PATRICIA Randomized Controlled Trials"],"prefix":"10.1093","volume":"112","author":[{"given":"Joseph E","family":"Tota","sequence":"first","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Struyf","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua N","family":"Sampson","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"},{"name":"Proyecto Epidemiol\u00f3gico Guanacaste, Fundaci\u00f3n INCIENSA, Guanacaste, Costa Rica"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Ryser","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolando","family":"Herrero","sequence":"additional","affiliation":[{"name":"Proyecto Epidemiol\u00f3gico Guanacaste, Fundaci\u00f3n INCIENSA, Guanacaste, Costa Rica"},{"name":"Section of Early Detection and Prevention, International Agency for Research on Cancer, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Schussler","sequence":"additional","affiliation":[{"name":"Information Management Services, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naveen","family":"Karkada","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Cecilia","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Proyecto Epidemiol\u00f3gico Guanacaste, Fundaci\u00f3n INCIENSA, San Jos\u00e9, Costa Rica"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0299-7783","authenticated-orcid":false,"given":"Nicolas","family":"Folschweiller","sequence":"additional","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Porras","sequence":"additional","affiliation":[{"name":"Proyecto Epidemiol\u00f3gico Guanacaste, Fundaci\u00f3n INCIENSA, San Jos\u00e9, Costa Rica"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Schiffman","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John 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