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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of Fewer than Three Doses of an HPV-16/18 AS04 adjuvanted Vaccine: Combined Analysis of Data from the Costa Rica Vaccine Trial and the PATRICIA Trial</title><author><name sortKey="Kreimer, Aimee R" sort="Kreimer, Aimee R" uniqKey="Kreimer A" first="Aimée R" last="Kreimer">Aimée R. Kreimer</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Struyf, Frank" sort="Struyf, Frank" uniqKey="Struyf F" first="Frank" last="Struyf">Frank Struyf</name><affiliation><nlm:aff id="A2">GSK Vaccines, Wavre, Belgium</nlm:aff></affiliation></author><author><name sortKey="Del Rosario Raymundo, Maria Rowena" sort="Del Rosario Raymundo, Maria Rowena" uniqKey="Del Rosario Raymundo M" first="Maria Rowena" last="Del Rosario-Raymundo">Maria Rowena Del Rosario-Raymundo</name><affiliation><nlm:aff id="A3">Department of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines</nlm:aff></affiliation></author><author><name sortKey="Hildesheim, Allan" sort="Hildesheim, Allan" uniqKey="Hildesheim A" first="Allan" last="Hildesheim">Allan Hildesheim</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Skinner, S Rachel" sort="Skinner, S Rachel" uniqKey="Skinner S" first="S Rachel" last="Skinner">S Rachel Skinner</name><affiliation><nlm:aff id="A4">Vaccine Trials Group, Telethon Institute for Child Health Research, Perth, W.A and Sydney University Discipline of Paediatrics and Child Health, Children’s Hospital at Westmead, Sydney, NSW, Australia</nlm:aff></affiliation></author><author><name sortKey="Wacholder, Sholom" sort="Wacholder, Sholom" uniqKey="Wacholder S" first="Sholom" last="Wacholder">Sholom Wacholder</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Garland, Suzanne M" sort="Garland, Suzanne M" uniqKey="Garland S" first="Suzanne M" last="Garland">Suzanne M. Garland</name><affiliation><nlm:aff id="A5">Microbiology and Infectious Diseases Department, Royal Women’s Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Childrens Research Institute Melbourne, VIC, Australia</nlm:aff></affiliation></author><author><name sortKey="Herrero, Rolando" sort="Herrero, Rolando" uniqKey="Herrero R" first="Rolando" last="Herrero">Rolando Herrero</name><affiliation><nlm:aff id="A6">Proyecto Epidemiologico Guanacaste, San José, Costa Rica</nlm:aff></affiliation><affiliation><nlm:aff id="A7">Section of Early Detection and Prevention, International Agency for Research on Cancer, Lyon, France</nlm:aff></affiliation></author><author><name sortKey="David, Marie Pierre" sort="David, Marie Pierre" uniqKey="David M" first="Marie-Pierre" last="David">Marie-Pierre David</name><affiliation><nlm:aff id="A2">GSK Vaccines, Wavre, Belgium</nlm:aff></affiliation></author><author><name sortKey="Wheeler, Cosette M" sort="Wheeler, Cosette M" uniqKey="Wheeler C" first="Cosette M" last="Wheeler">Cosette M. Wheeler</name><affiliation><nlm:aff id="A8">Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26071347</idno><idno type="pmc">4498478</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4498478</idno><idno type="RBID">PMC:4498478</idno><idno type="doi">10.1016/S1470-2045(15)00047-9</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">001D84</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001D84</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy of Fewer than Three Doses of an HPV-16/18 AS04 adjuvanted Vaccine: Combined Analysis of Data from the Costa Rica Vaccine Trial and the PATRICIA Trial</title><author><name sortKey="Kreimer, Aimee R" sort="Kreimer, Aimee R" uniqKey="Kreimer A" first="Aimée R" last="Kreimer">Aimée R. Kreimer</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Struyf, Frank" sort="Struyf, Frank" uniqKey="Struyf F" first="Frank" last="Struyf">Frank Struyf</name><affiliation><nlm:aff id="A2">GSK Vaccines, Wavre, Belgium</nlm:aff></affiliation></author><author><name sortKey="Del Rosario Raymundo, Maria Rowena" sort="Del Rosario Raymundo, Maria Rowena" uniqKey="Del Rosario Raymundo M" first="Maria Rowena" last="Del Rosario-Raymundo">Maria Rowena Del Rosario-Raymundo</name><affiliation><nlm:aff id="A3">Department of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines</nlm:aff></affiliation></author><author><name sortKey="Hildesheim, Allan" sort="Hildesheim, Allan" uniqKey="Hildesheim A" first="Allan" last="Hildesheim">Allan Hildesheim</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Skinner, S Rachel" sort="Skinner, S Rachel" uniqKey="Skinner S" first="S Rachel" last="Skinner">S Rachel Skinner</name><affiliation><nlm:aff id="A4">Vaccine Trials Group, Telethon Institute for Child Health Research, Perth, W.A and Sydney University Discipline of Paediatrics and Child Health, Children’s Hospital at Westmead, Sydney, NSW, Australia</nlm:aff></affiliation></author><author><name sortKey="Wacholder, Sholom" sort="Wacholder, Sholom" uniqKey="Wacholder S" first="Sholom" last="Wacholder">Sholom Wacholder</name><affiliation><nlm:aff id="A1">Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Garland, Suzanne M" sort="Garland, Suzanne M" uniqKey="Garland S" first="Suzanne M" last="Garland">Suzanne M. Garland</name><affiliation><nlm:aff id="A5">Microbiology and Infectious Diseases Department, Royal Women’s Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Childrens Research Institute Melbourne, VIC, Australia</nlm:aff></affiliation></author><author><name sortKey="Herrero, Rolando" sort="Herrero, Rolando" uniqKey="Herrero R" first="Rolando" last="Herrero">Rolando Herrero</name><affiliation><nlm:aff id="A6">Proyecto Epidemiologico Guanacaste, San José, Costa Rica</nlm:aff></affiliation><affiliation><nlm:aff id="A7">Section of Early Detection and Prevention, International Agency for Research on Cancer, Lyon, France</nlm:aff></affiliation></author><author><name sortKey="David, Marie Pierre" sort="David, Marie Pierre" uniqKey="David M" first="Marie-Pierre" last="David">Marie-Pierre David</name><affiliation><nlm:aff id="A2">GSK Vaccines, Wavre, Belgium</nlm:aff></affiliation></author><author><name sortKey="Wheeler, Cosette M" sort="Wheeler, Cosette M" uniqKey="Wheeler C" first="Cosette M" last="Wheeler">Cosette M. Wheeler</name><affiliation><nlm:aff id="A8">Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA</nlm:aff></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Limited data suggest one or two doses of the HPV vaccines confer similar protection to the three-dose regimen. This study aimed to further evaluate the question of reduced-dose efficacy of the HPV-16/18 vaccine.</p></sec><sec id="S2"><title>Methods</title><p id="P2">Summary-level data from the Costa Rica Vaccine Trial (CVT; NCT00128661) and the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT001226810), two phase III controlled, randomized, double-blind, clinical trials of the HPV-16/18 AS04-adjuvanted vaccine among young women, were combined in a <italic>post-hoc</italic> analysis (GSK e-track 202142) to investigate efficacy of fewer doses of the HPV-16/18 vaccine after four years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet some received fewer doses. After excluding women with <12-months follow-up or those HPV16/18 DNA-positive at enrollment (for the HPV16/18 endpoint), vaccine efficacy (VE) was calculated against one-time detection of incident HPV infections after three (n=11,110 HPV:11,217control), two (n=611:574), and one (N=292:251) dose(s). The main aim of the study was to ascertain HPV16/18 VE in both full and naïve cohorts, as well as to explore protection conferred against non-vaccine HPV types, by number of doses received.</p></sec><sec id="S3"><title>Findings</title><p id="P3">VE against incident HPV16/18 infections for three doses was 77·0% (95%CI 74·7 to 79·1%), two doses was 76·0% (95%CI 62·0 to 85·3%), and one dose was 85·7% (95%CI 70·7 to 93·7%). VE against incident HPV31/33/45 infections for three doses was 59·7% (95%CI 56·0 to 63·0%), two doses was 37·7% (95%CI 12·4 to 55·9%), and one dose was 36·6% (95%CI −5·4 to 62·2%). However, two-dose women who received their second dose at six months, but not those receiving it at one month, had efficacy estimates against HPV 31/33/45 similar to the three-dose group (VE 68·1%, 95%CI 27·0 to 87·0%; CVT data only).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">Four years following vaccination of women aged 15 to 25 years, one and two dose(s) of the HPV16/18 vaccine appear to protect against cervical HPV16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by six months additionally provided limited cross-protection. These data argue for a direct evaluation of one-dose efficacy of the HPV16/18 vaccine.</p></sec><sec id="S5"><title>Funding</title><p id="P5">The CVT trial was sponsored and funded by the US National Cancer Institute, NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women’s Health, and done with the support from the Ministry of Health of Costa Rica. Vaccine was provided for CVT by GlaxoSmithKline Biologicals SA, under a Clinical Trials Agreement with the NCI. GlaxoSmithKline Biologicals SA provided support for aspects of the trial associated with regulatory submission needs of the company under US Food and Drug Administration BB-IND 7920. The PATRICIA trial was sponsored by GlaxoSmithKline Biologicals SA.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The Lancet. Oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">26071347</article-id><article-id pub-id-type="pmc">4498478</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(15)00047-9</article-id><article-id pub-id-type="manuscript">NIHMS700097</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Efficacy of Fewer than Three Doses of an HPV-16/18 AS04 adjuvanted Vaccine: Combined Analysis of Data from the Costa Rica Vaccine Trial and the PATRICIA Trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kreimer</surname><given-names>Aimée R</given-names></name><degrees>Ph.D</degrees><xref ref-type="aff" rid="A1">1</xref><xref rid="FN2" ref-type="author-notes">*</xref><xref rid="FN1" ref-type="author-notes">†</xref></contrib><contrib contrib-type="author"><name><surname>Struyf</surname><given-names>Frank</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A2">2</xref><xref rid="FN2" ref-type="author-notes">*</xref></contrib><contrib contrib-type="author"><name><surname>Del Rosario-Raymundo</surname><given-names>Maria Rowena</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Hildesheim</surname><given-names>Allan</given-names><prefix>Prof.</prefix></name><degrees>Ph.D.</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Skinner</surname><given-names>S Rachel</given-names></name><degrees>Ph.D.</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Wacholder</surname><given-names>Sholom</given-names><prefix>Prof.</prefix></name><degrees>Ph.D.</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Garland</surname><given-names>Suzanne M</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Herrero</surname><given-names>Rolando</given-names></name><degrees>Ph.D.</degrees><xref ref-type="aff" rid="A6">6</xref><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>David</surname><given-names>Marie-Pierre</given-names></name><degrees>M.Sc.</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Wheeler</surname><given-names>Cosette M</given-names><prefix>Prof.</prefix></name><degrees>Ph.D.</degrees><xref ref-type="aff" rid="A8">8</xref><xref rid="FN1" ref-type="author-notes">†</xref></contrib><on-behalf-of>For the Costa Rica Vaccine Trial and The PATRICIA study groups</on-behalf-of></contrib-group><aff id="A1"><label>1</label>Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA</aff><aff id="A2"><label>2</label>GSK Vaccines, Wavre, Belgium</aff><aff id="A3"><label>3</label>Department of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines</aff><aff id="A4"><label>4</label>Vaccine Trials Group, Telethon Institute for Child Health Research, Perth, W.A and Sydney University Discipline of Paediatrics and Child Health, Children’s Hospital at Westmead, Sydney, NSW, Australia</aff><aff id="A5"><label>5</label>Microbiology and Infectious Diseases Department, Royal Women’s Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Childrens Research Institute Melbourne, VIC, Australia</aff><aff id="A6"><label>6</label>Proyecto Epidemiologico Guanacaste, San José, Costa Rica</aff><aff id="A7"><label>7</label>Section of Early Detection and Prevention, International Agency for Research on Cancer, Lyon, France</aff><aff id="A8"><label>8</label>Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA</aff><author-notes><corresp id="FN1"><label>†</label><bold>Co-corresponding authors:</bold> Dr. Aimée R. Kreimer, Division of Cancer Epidemiology and Genetics, US National Cancer Institute, NIH, Bethesda, MD, USA. Phone: +1 2402767102, <email>kreimera@mail.nih.gov</email>; Dr Cosette M. Wheeler, Departments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, MSC 02-1670 Bldg 191, 1 University of New Mexico, Albuquerque, NM 87131 USA. Fax: +1 505 277 0265. <email>cwheeler@salud.unm.edu</email></corresp><fn id="FN2"><label>*</label><p>Indicates co-first author</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>24</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>09</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>7</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>01</day><month>7</month><year>2016</year></pub-date><volume>16</volume><issue>7</issue><fpage>775</fpage><lpage>786</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(15)00047-9</pmc-comment>
<permissions><copyright-statement>© Published by Elsevier Ltd.</copyright-statement><license license-type="open-access"><license-p>This manuscript version is made available under the CC BY-NC-ND 4.0 license.</license-p></license></permissions><abstract><sec id="S1"><title>Background</title><p id="P1">Limited data suggest one or two doses of the HPV vaccines confer similar protection to the three-dose regimen. This study aimed to further evaluate the question of reduced-dose efficacy of the HPV-16/18 vaccine.</p></sec><sec id="S2"><title>Methods</title><p id="P2">Summary-level data from the Costa Rica Vaccine Trial (CVT; NCT00128661) and the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT001226810), two phase III controlled, randomized, double-blind, clinical trials of the HPV-16/18 AS04-adjuvanted vaccine among young women, were combined in a <italic>post-hoc</italic> analysis (GSK e-track 202142) to investigate efficacy of fewer doses of the HPV-16/18 vaccine after four years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet some received fewer doses. After excluding women with <12-months follow-up or those HPV16/18 DNA-positive at enrollment (for the HPV16/18 endpoint), vaccine efficacy (VE) was calculated against one-time detection of incident HPV infections after three (n=11,110 HPV:11,217control), two (n=611:574), and one (N=292:251) dose(s). The main aim of the study was to ascertain HPV16/18 VE in both full and naïve cohorts, as well as to explore protection conferred against non-vaccine HPV types, by number of doses received.</p></sec><sec id="S3"><title>Findings</title><p id="P3">VE against incident HPV16/18 infections for three doses was 77·0% (95%CI 74·7 to 79·1%), two doses was 76·0% (95%CI 62·0 to 85·3%), and one dose was 85·7% (95%CI 70·7 to 93·7%). VE against incident HPV31/33/45 infections for three doses was 59·7% (95%CI 56·0 to 63·0%), two doses was 37·7% (95%CI 12·4 to 55·9%), and one dose was 36·6% (95%CI −5·4 to 62·2%). However, two-dose women who received their second dose at six months, but not those receiving it at one month, had efficacy estimates against HPV 31/33/45 similar to the three-dose group (VE 68·1%, 95%CI 27·0 to 87·0%; CVT data only).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">Four years following vaccination of women aged 15 to 25 years, one and two dose(s) of the HPV16/18 vaccine appear to protect against cervical HPV16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by six months additionally provided limited cross-protection. These data argue for a direct evaluation of one-dose efficacy of the HPV16/18 vaccine.</p></sec><sec id="S5"><title>Funding</title><p id="P5">The CVT trial was sponsored and funded by the US National Cancer Institute, NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women’s Health, and done with the support from the Ministry of Health of Costa Rica. Vaccine was provided for CVT by GlaxoSmithKline Biologicals SA, under a Clinical Trials Agreement with the NCI. GlaxoSmithKline Biologicals SA provided support for aspects of the trial associated with regulatory submission needs of the company under US Food and Drug Administration BB-IND 7920. The PATRICIA trial was sponsored by GlaxoSmithKline Biologicals SA.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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