Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9–14 years: Results to month 12 from a randomized trial
Identifieur interne : 000007 ( Pmc/Curation ); précédent : 000006; suivant : 000008Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9–14 years: Results to month 12 from a randomized trial
Auteurs : Ting Fan Leung [Hong Kong] ; Anthony Pak-Yin Liu [Hong Kong] ; Fong Seng Lim [Singapour] ; Franck Thollot [France] ; Helen May Lin Oh [Singapour] ; Bee Wah Lee [Singapour] ; Lars Rombo [Suède] ; Ngiap Chuan Tan [Singapour] ; Roman Rouzier [France] ; Damien Friel [Belgique] ; Benoit De Muynck [Belgique] ; Stéphanie De Simoni [Belgique] ; Pemmaraju Suryakiran [Inde] ; Marjan Hezareh [Belgique] ; Nicolas Folschweiller [Belgique] ; Florence Thomas [Belgique] ; Frank Struyf [Belgique]Source :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 2015.
Abstract
This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9–14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49–1.91] for anti-HPV-16 and 4.52 [3.97–5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54–1.93] for anti-HPV-16 and 3.22 [2.82–3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9–14 years).
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DOI: 10.1080/21645515.2015.1050570
PubMed: 26062002
PubMed Central: 4514190
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Li Ka Shing Faculty of Medicine; The University of Hong Kong</institution>;<country>Hong Kong</country></nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation><nlm:aff id="af0014">These authors equally contributed to the work.</nlm:aff></affiliation></author><author><name sortKey="Lim, Fong Seng" sort="Lim, Fong Seng" uniqKey="Lim F" first="Fong Seng" last="Lim">Fong Seng Lim</name><affiliation wicri:level="1"><nlm:aff id="af0003"><institution>National Healthcare Group Polyclinics and National University of Singapore</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thollot, Franck" sort="Thollot, Franck" uniqKey="Thollot F" first="Franck" last="Thollot">Franck Thollot</name><affiliation wicri:level="1"><nlm:aff id="af0004"><institution>Association Française de Pédiatrie Ambulatoire (AFPA); 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Sormland County Council; Uppsala University and Karolinska Institute</institution>; Stockholm,<country>Sweden</country></nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Tan, Ngiap Chuan" sort="Tan, Ngiap Chuan" uniqKey="Tan N" first="Ngiap Chuan" last="Tan">Ngiap Chuan Tan</name><affiliation wicri:level="1"><nlm:aff id="af0008"><institution>SingHealth Polyclinics and DUKE-NUS Graduate Medical School</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rouzier, Roman" sort="Rouzier, Roman" uniqKey="Rouzier R" first="Roman" last="Rouzier">Roman Rouzier</name><affiliation wicri:level="1"><nlm:aff id="af0009"><institution>Institut Curie</institution>; Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Friel, Damien" sort="Friel, Damien" uniqKey="Friel D" first="Damien" last="Friel">Damien Friel</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Muynck, Benoit" sort="De Muynck, Benoit" uniqKey="De Muynck B" first="Benoit" last="De Muynck">Benoit De Muynck</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Simoni, Stephanie" sort="De Simoni, Stephanie" uniqKey="De Simoni S" first="Stéphanie" last="De Simoni">Stéphanie De Simoni</name><affiliation wicri:level="1"><nlm:aff id="af0011"><institution>GSK Vaccines</institution>; Rixensart,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Suryakiran, Pemmaraju" sort="Suryakiran, Pemmaraju" uniqKey="Suryakiran P" first="Pemmaraju" last="Suryakiran">Pemmaraju Suryakiran</name><affiliation wicri:level="1"><nlm:aff id="af0012"><institution>GlaxoSmithKline Pharmaceuticals India Ltd.</institution>; Bangalore,<country>India</country></nlm:aff><country xml:lang="fr">Inde</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hezareh, Marjan" sort="Hezareh, Marjan" uniqKey="Hezareh M" first="Marjan" last="Hezareh">Marjan Hezareh</name><affiliation wicri:level="1"><nlm:aff id="af0013"><institution>Chiltern International for GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Folschweiller, Nicolas" sort="Folschweiller, Nicolas" uniqKey="Folschweiller N" first="Nicolas" last="Folschweiller">Nicolas Folschweiller</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, Florence" sort="Thomas, Florence" uniqKey="Thomas F" first="Florence" last="Thomas">Florence Thomas</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Struyf, Frank" sort="Struyf, Frank" uniqKey="Struyf F" first="Frank" last="Struyf">Frank Struyf</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26062002</idno><idno type="pmc">4514190</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514190</idno><idno type="RBID">PMC:4514190</idno><idno type="doi">10.1080/21645515.2015.1050570</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000007</idno><idno type="wicri:Area/Pmc/Curation">000007</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9–14 years: Results to month 12 from a randomized trial</title><author><name sortKey="Leung, Ting Fan" sort="Leung, Ting Fan" uniqKey="Leung T" first="Ting Fan" last="Leung">Ting Fan Leung</name><affiliation wicri:level="1"><nlm:aff id="af0001"><institution>Department of Paediatrics; The Chinese University of Hong Kong</institution>; Shatin,<country>Hong Kong</country></nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation><nlm:aff id="af0014">These authors equally contributed to the work.</nlm:aff></affiliation></author><author><name sortKey="Liu, Anthony Pak Yin" sort="Liu, Anthony Pak Yin" uniqKey="Liu A" first="Anthony Pak-Yin" last="Liu">Anthony Pak-Yin Liu</name><affiliation wicri:level="1"><nlm:aff id="af0002"><institution>Department of Paediatrics and Adolescent Medicine; Li Ka Shing Faculty of Medicine; The University of Hong Kong</institution>;<country>Hong Kong</country></nlm:aff><country xml:lang="fr">Hong Kong</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation><nlm:aff id="af0014">These authors equally contributed to the work.</nlm:aff></affiliation></author><author><name sortKey="Lim, Fong Seng" sort="Lim, Fong Seng" uniqKey="Lim F" first="Fong Seng" last="Lim">Fong Seng Lim</name><affiliation wicri:level="1"><nlm:aff id="af0003"><institution>National Healthcare Group Polyclinics and National University of Singapore</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thollot, Franck" sort="Thollot, Franck" uniqKey="Thollot F" first="Franck" last="Thollot">Franck Thollot</name><affiliation wicri:level="1"><nlm:aff id="af0004"><institution>Association Française de Pédiatrie Ambulatoire (AFPA); Essey Les Nancy</institution>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Oh, Helen May Lin" sort="Oh, Helen May Lin" uniqKey="Oh H" first="Helen May Lin" last="Oh">Helen May Lin Oh</name><affiliation wicri:level="1"><nlm:aff id="af0005"><institution>Division of Infectious Disease; Changi General Hospital</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lee, Bee Wah" sort="Lee, Bee Wah" uniqKey="Lee B" first="Bee Wah" last="Lee">Bee Wah Lee</name><affiliation wicri:level="1"><nlm:aff id="af0006"><institution>Mount Elizabeth Medical Center and National University of Singapore</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rombo, Lars" sort="Rombo, Lars" uniqKey="Rombo L" first="Lars" last="Rombo">Lars Rombo</name><affiliation wicri:level="1"><nlm:aff id="af0007"><institution>Centre for Clinical Research; Sormland County Council; Uppsala University and Karolinska Institute</institution>; Stockholm,<country>Sweden</country></nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Tan, Ngiap Chuan" sort="Tan, Ngiap Chuan" uniqKey="Tan N" first="Ngiap Chuan" last="Tan">Ngiap Chuan Tan</name><affiliation wicri:level="1"><nlm:aff id="af0008"><institution>SingHealth Polyclinics and DUKE-NUS Graduate Medical School</institution>;<country>Singapore</country></nlm:aff><country xml:lang="fr">Singapour</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rouzier, Roman" sort="Rouzier, Roman" uniqKey="Rouzier R" first="Roman" last="Rouzier">Roman Rouzier</name><affiliation wicri:level="1"><nlm:aff id="af0009"><institution>Institut Curie</institution>; Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Friel, Damien" sort="Friel, Damien" uniqKey="Friel D" first="Damien" last="Friel">Damien Friel</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Muynck, Benoit" sort="De Muynck, Benoit" uniqKey="De Muynck B" first="Benoit" last="De Muynck">Benoit De Muynck</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Simoni, Stephanie" sort="De Simoni, Stephanie" uniqKey="De Simoni S" first="Stéphanie" last="De Simoni">Stéphanie De Simoni</name><affiliation wicri:level="1"><nlm:aff id="af0011"><institution>GSK Vaccines</institution>; Rixensart,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Suryakiran, Pemmaraju" sort="Suryakiran, Pemmaraju" uniqKey="Suryakiran P" first="Pemmaraju" last="Suryakiran">Pemmaraju Suryakiran</name><affiliation wicri:level="1"><nlm:aff id="af0012"><institution>GlaxoSmithKline Pharmaceuticals India Ltd.</institution>; Bangalore,<country>India</country></nlm:aff><country xml:lang="fr">Inde</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hezareh, Marjan" sort="Hezareh, Marjan" uniqKey="Hezareh M" first="Marjan" last="Hezareh">Marjan Hezareh</name><affiliation wicri:level="1"><nlm:aff id="af0013"><institution>Chiltern International for GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Folschweiller, Nicolas" sort="Folschweiller, Nicolas" uniqKey="Folschweiller N" first="Nicolas" last="Folschweiller">Nicolas Folschweiller</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, Florence" sort="Thomas, Florence" uniqKey="Thomas F" first="Florence" last="Thomas">Florence Thomas</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Struyf, Frank" sort="Struyf, Frank" uniqKey="Struyf F" first="Frank" last="Struyf">Frank Struyf</name><affiliation wicri:level="1"><nlm:aff id="af0010"><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Human Vaccines & Immunotherapeutics</title><idno type="ISSN">2164-5515</idno><idno type="eISSN">2164-554X</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9–14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49–1.91] for anti-HPV-16 and 4.52 [3.97–5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54–1.93] for anti-HPV-16 and 3.22 [2.82–3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9–14 years).</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Einstein, Mh" uniqKey="Einstein M">MH Einstein</name></author><author><name sortKey="Baron, M" uniqKey="Baron M">M Baron</name></author><author><name sortKey="Levin, Mj" uniqKey="Levin M">MJ Levin</name></author><author><name sortKey="Chatterjee, A" uniqKey="Chatterjee A">A Chatterjee</name></author><author><name sortKey="Edwards, Rp" uniqKey="Edwards R">RP Edwards</name></author><author><name sortKey="Zepp, F" uniqKey="Zepp F">F Zepp</name></author><author><name sortKey="Carletti, I" uniqKey="Carletti I">I Carletti</name></author><author><name sortKey="Dessy, Fj" uniqKey="Dessy F">FJ Dessy</name></author><author><name sortKey="Trofa, Af" uniqKey="Trofa A">AF 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="pmc">KHVI</journal-id><journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title></journal-title-group><issn pub-type="ppub">2164-5515</issn><issn pub-type="epub">2164-554X</issn><publisher><publisher-name>Taylor & Francis</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26062002</article-id><article-id pub-id-type="pmc">4514190</article-id><article-id pub-id-type="publisher-id">1050570</article-id><article-id pub-id-type="doi">10.1080/21645515.2015.1050570</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Paper</subject></subj-group></article-categories><title-group><article-title>Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9–14 years: Results to month 12 from a randomized trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Leung</surname><given-names>Ting Fan</given-names></name><xref ref-type="aff" rid="af0001"><sup>1</sup></xref><xref ref-type="aff" rid="af0014"><sup>#</sup></xref><xref ref-type="corresp" rid="an0001"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Liu</surname><given-names>Anthony Pak-Yin</given-names></name><xref ref-type="aff" rid="af0002"><sup>2</sup></xref><xref ref-type="aff" rid="af0014"><sup>#</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lim</surname><given-names>Fong Seng</given-names></name><xref ref-type="aff" rid="af0003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Thollot</surname><given-names>Franck</given-names></name><xref ref-type="aff" rid="af0004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Oh</surname><given-names>Helen May Lin</given-names></name><xref ref-type="aff" rid="af0005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>Bee Wah</given-names></name><xref ref-type="aff" rid="af0006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Rombo</surname><given-names>Lars</given-names></name><xref ref-type="aff" rid="af0007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Tan</surname><given-names>Ngiap Chuan</given-names></name><xref ref-type="aff" rid="af0008"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Rouzier</surname><given-names>Roman</given-names></name><xref ref-type="aff" rid="af0009"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Friel</surname><given-names>Damien</given-names></name><xref ref-type="aff" rid="af0010"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>De Muynck</surname><given-names>Benoit</given-names></name><xref ref-type="aff" rid="af0010"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>De Simoni</surname><given-names>Stéphanie</given-names></name><xref ref-type="aff" rid="af0011"><sup>11</sup></xref></contrib><contrib contrib-type="author"><name><surname>Suryakiran</surname><given-names>Pemmaraju</given-names></name><xref ref-type="aff" rid="af0012"><sup>12</sup></xref></contrib><contrib contrib-type="author"><name><surname>Hezareh</surname><given-names>Marjan</given-names></name><xref ref-type="aff" rid="af0013"><sup>13</sup></xref></contrib><contrib contrib-type="author"><name><surname>Folschweiller</surname><given-names>Nicolas</given-names></name><xref ref-type="aff" rid="af0010"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>Thomas</surname><given-names>Florence</given-names></name><xref ref-type="aff" rid="af0010"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>Struyf</surname><given-names>Frank</given-names></name><xref ref-type="aff" rid="af0010"><sup>10</sup></xref></contrib><aff id="af0001"><label>1</label><institution>Department of Paediatrics; The Chinese University of Hong Kong</institution>; Shatin,<country>Hong Kong</country></aff><aff id="af0002"><label>2</label><institution>Department of Paediatrics and Adolescent Medicine; Li Ka Shing Faculty of Medicine; The University of Hong Kong</institution>;<country>Hong Kong</country></aff><aff id="af0003"><label>3</label><institution>National Healthcare Group Polyclinics and National University of Singapore</institution>;<country>Singapore</country></aff><aff id="af0004"><label>4</label><institution>Association Française de Pédiatrie Ambulatoire (AFPA); Essey Les Nancy</institution>,<country>France</country></aff><aff id="af0005"><label>5</label><institution>Division of Infectious Disease; Changi General Hospital</institution>;<country>Singapore</country></aff><aff id="af0006"><label>6</label><institution>Mount Elizabeth Medical Center and National University of Singapore</institution>;<country>Singapore</country></aff><aff id="af0007"><label>7</label><institution>Centre for Clinical Research; Sormland County Council; Uppsala University and Karolinska Institute</institution>; Stockholm,<country>Sweden</country></aff><aff id="af0008"><label>8</label><institution>SingHealth Polyclinics and DUKE-NUS Graduate Medical School</institution>;<country>Singapore</country></aff><aff id="af0009"><label>9</label><institution>Institut Curie</institution>; Paris,<country>France</country></aff><aff id="af0010"><label>10</label><institution>GSK Vaccines</institution>; Wavre,<country>Belgium</country></aff><aff id="af0011"><label>11</label><institution>GSK Vaccines</institution>; Rixensart,<country>Belgium</country></aff><aff id="af0012"><label>12</label><institution>GlaxoSmithKline Pharmaceuticals India Ltd.</institution>; Bangalore,<country>India</country></aff><aff id="af0013"><label>13</label><institution>Chiltern International for GSK Vaccines</institution>; Wavre,<country>Belgium</country></aff><aff id="af0014"><label>#</label>These authors equally contributed to the work.</aff></contrib-group><author-notes><corresp id="an0001"><label>*</label>Correspondence to: Ting Fan Leung; Email: <email xlink:href="tfleung@cuhk.edu.hk">tfleung@cuhk.edu.hk</email></corresp></author-notes><pub-date pub-type="epub"><day>10</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="collection"><month>7</month><year>2015</year></pub-date><volume>11</volume><issue>7</issue><fpage seq="18">1689</fpage><lpage>1702</lpage><history><date date-type="received"><day>16</day><month>3</month><year>2015</year></date><date date-type="rev-recd"><day>23</day><month>4</month><year>2015</year></date><date date-type="accepted"><day>8</day><month>5</month><year>2015</year></date></history><permissions><copyright-statement>© 2015 The Author(s). Published with license by Taylor and Francis Group, LLC</copyright-statement><copyright-statement content-type="description">© Ting Fan Leung, Anthony Pak-Yin Liu, Fong Seng Lim, Franck Thollot, Helen May Lin Oh, Bee Wah Lee, Lars Rombo, Ngiap Chuan Tan, Roman Rouzier, Damien Friel, Benoit De Muynck, Stéphanie De Simoni, Pemmaraju Suryakiran, Marjan Hezareh, Nicolas Folschweiller, Florence Thomas, and Frank Struyf</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>The Author(s)</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link>), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="khvi-11-07-1050570.pdf"></self-uri><abstract><p>This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9–14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) at M7 in the according-to-protocol immunogenicity cohort (ATP-I) and total vaccinated cohort, respectively. Secondary objectives included non-inferiority/superiority of HPV-16/18(2D) vs. HPV-6/11/16/18(3D) at M7, non-inferiority/superiority at M12, HPV-16/18 neutralizing antibodies, frequencies of T-cells/B-cells, reactogenicity and safety. Antibody responses at M7 for HPV-16/18(2D) were superior to those for HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) (lower limit of 95% confidence interval for geometric mean titer ratio (GMR) was >1): HPV-16/18(2D)/HPV-6/11/16/18(2D) GMRs were 1.69 [1.49–1.91] for anti-HPV-16 and 4.52 [3.97–5.13] for anti-HPV-18; HPV-16/18(2D)/HPV-6/11/16/18(3D) GMRs were 1.72 [1.54–1.93] for anti-HPV-16 and 3.22 [2.82–3.68] for anti-HPV-18; p = 0.0001 for all comparisons. Non-inferiority/superiority was also demonstrated at M12. Among initially seronegative girls in the ATP-I, neutralizing antibody titers were at least 1.8-fold higher for HPV-16/18(2D) vs. HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D) at M7 and M12. Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9–14 years).</p></abstract><kwd-group kwd-group-type="author"><title>Keywords</title><kwd>administration schedule</kwd><kwd>female adolescents</kwd><kwd>immunogenicity</kwd><kwd>human papillomavirus (HPV) vaccines</kwd><kwd>safety</kwd></kwd-group><counts><fig-count count="4"></fig-count><table-count count="2"></table-count><ref-count count="50"></ref-count><page-count count="14"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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