Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial.
Identifieur interne : 000233 ( Hal/Corpus ); précédent : 000232; suivant : 000234Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial.
Auteurs : Xavier Duval ; Adrian Caplanusi ; Henri Laurichesse ; Dominique Deplanque ; Pierre Loulergue ; Tejaswini Vaman ; Odile Launay ; Paul GillardSource :
- BMC Infectious Diseases [ 1471-2334 ] ; 2012.
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Abstract
UNLABELLED: ABSTRACT: BACKGROUND: Flexibility of vaccination schedule and lower antigen content can facilitate pandemic vaccine coverage. We assessed the immune response and safety of AS03-adjuvanted A/California/7/2009 H1N1 pandemic vaccine containing half of the registered adult haemagglutinin (HA) antigen content, administered as a two-dose schedule at intervals of 21 days or 6 months in both young and elderly adults. METHODS: In this open-label randomized trial, healthy adults aged 18-60 years (N = 163) and >60 years (N = 143) received AS03A-adjuvanted A/California/7/2009 H1N1 vaccine containing 1.9 μg HA on Day 0. A second dose was given on Day 21 (n = 177) or Day 182 (n = 106). Haemagglutination-inhibition (HI) antibody responses were analyzed on Days 0, 21, 42, 182, 364 and additionally on Day 203 for subjects vaccinated on Day 182. Solicited and unsolicited adverse events were recorded. RESULTS: The HI antibody response in both age strata 21 days after the first dose met and exceeded all regulatory acceptance criteria although the results suggested a lower response in the older age stratum (geometric mean titres [GMTs] for HI antibodies of 420.5 for subjects aged 18-60 years and 174.4 for those >60 years). A second dose of AS03A adjuvanted A/H1N1/2009 vaccine induced a further increase in antibody titres and the response was similar whether the second dose was administered at 21 days (GMTs of 771.8 for 18-60 years and 400.9 for >60 years) or 6 months (GMTs of 708.3 for 18-60 years and 512.1 for >60 years) following the first dose. Seroprotection rates remained high at 6 months after one dose or two doses while at 12 months rates tended to be higher for the 6 month interval schedule (93.3% for 18-60 years and 80.4% for >60 years) than the 21 day schedule (82.3% for 18-60 years and 50.0% for >60 years). Reactogenicity/safety profiles were similar for both schedules, there was no evidence of an increase in reactogenicity following the second dose. CONCLUSIONS: The results indicate that flexibility in the dosing interval for AS03A adjuvanted vaccine may be possible. Such flexibility could help to reduce the logistic stress on delivery of pandemic vaccination programmes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00975884.
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DOI: 10.1186/1471-2334-12-162
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Hal:inserm-00765023Le document en format XML
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Paris 7</orgName> <orgName type="acronym">UPD7</orgName> <date type="end">2019-12-31</date> <desc> <address> <addrLine>5 rue Thomas-Mann - 75205 Paris cedex 13</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-paris-diderot.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Caplanusi, Adrian" sort="Caplanusi, Adrian" uniqKey="Caplanusi A" first="Adrian" last="Caplanusi">Adrian Caplanusi</name><affiliation><hal:affiliation type="institution" xml:id="struct-209482" status="VALID"> <orgName>GlaxoSmithKline Vaccines [Wavre]</orgName> <desc> <address> <addrLine>Avenue Fleming 20, 1300 Wavre</addrLine> <country key="BE"></country> </address> </desc> </hal:affiliation></affiliation></author><author><name sortKey="Laurichesse, Henri" sort="Laurichesse, Henri" uniqKey="Laurichesse H" first="Henri" last="Laurichesse">Henri Laurichesse</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-195699" status="OLD"> <orgName>Unité de Nutrition Humaine</orgName> <orgName type="acronym">UNH</orgName> <date type="end">2016-12-31</date> <desc> <address> <addrLine>Centre de Recherches Inra de Clermont-Fd/Theix / 63122 St Genès Champanelle</addrLine> <country key="FR"></country> </address> <ref type="url">http://www4.clermont.inra.fr/unh</ref> </desc> <listRelation> <relation name="UR1019" active="#struct-92114" type="direct"></relation> <relation active="#struct-300267" type="direct"></relation> <relation active="#struct-301603" type="direct"></relation> </listRelation> <tutelles><tutelle name="UR1019" active="#struct-92114" type="direct"><org type="institution" xml:id="struct-92114" status="OLD"> <orgName>Institut National de la Recherche Agronomique</orgName> <orgName type="acronym">INRA</orgName> <date type="start">1946-05-18</date> <date type="end">2019-12-31</date> <desc> <address> <country key="FR"></country> </address> <ref type="url">http://www.inra.fr</ref> </desc> </org></tutelle><tutelle active="#struct-300267" type="direct"><org type="institution" xml:id="struct-300267" status="OLD"> <orgName>Université d'Auvergne - Clermont-Ferrand I</orgName> <orgName type="acronym">UdA</orgName> <date type="end">2016-12-31</date> <desc> <address> <addrLine>49, Boulevard François-Mitterrand / CS 60032 / 63001 Clermont-Ferrand Cedex 1</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.u-clermont1.fr/</ref> </desc> </org></tutelle><tutelle active="#struct-301603" type="direct"><org type="institution" xml:id="struct-301603" status="INCOMING"> <orgName>Clermont Université</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Deplanque, Dominique" sort="Deplanque, Dominique" uniqKey="Deplanque D" first="Dominique" last="Deplanque">Dominique Deplanque</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-2617" status="OLD"> <orgName>CIC CHU ( Lille)/inserm</orgName> <desc> <address> <addrLine>Hopital Cardiologique LILLE , Bd du Pr Jules Leclercq 59037 LILLE CEDEX</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CIC9301" active="#struct-303623" type="direct"></relation> <relation active="#struct-361611" type="direct"></relation> </listRelation> <tutelles><tutelle name="CIC9301" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle><tutelle active="#struct-361611" type="direct"><org type="institution" xml:id="struct-361611" status="OLD"> <idno type="ISNI">0000000120977060</idno> <idno type="IdRef">026404389</idno> <orgName>Université de Lille, Droit et Santé</orgName> <date type="end">2017-12-31</date> <desc> <address> <addrLine>42 rue Paul Duez 59000 Lille</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-lille2.fr/</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Loulergue, Pierre" sort="Loulergue, Pierre" uniqKey="Loulergue P" first="Pierre" last="Loulergue">Pierre Loulergue</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-2593" status="OLD"> <orgName>CIC - Biotherapie - AP-HP (cochin - Pasteur)</orgName> <desc> <address> <addrLine>Hopital Cochin PARIS V 27, Rue du Faubourg Saint-Jacques 75679 PARIS CEDEX 14</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CBT505" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CBT505" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Vaman, Tejaswini" sort="Vaman, Tejaswini" uniqKey="Vaman T" first="Tejaswini" last="Vaman">Tejaswini Vaman</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-209488" status="INCOMING"> <orgName>GlaxoSmithKline Vaccines [Bangalore]</orgName> <desc> <address> <addrLine>Bangalore</addrLine> <country key="IN"></country> </address> </desc> <listRelation> <relation active="#struct-351272" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-351272" type="direct"><org type="institution" xml:id="struct-351272" status="INCOMING"> <orgName>India GSK Pharmaceuticals Ltd.</orgName> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name><affiliation><hal:affiliation type="laboratory" xml:id="struct-2593" status="OLD"> <orgName>CIC - Biotherapie - AP-HP (cochin - Pasteur)</orgName> <desc> <address> <addrLine>Hopital Cochin PARIS V 27, Rue du Faubourg Saint-Jacques 75679 PARIS CEDEX 14</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CBT505" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CBT505" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation></affiliation></author><author><name sortKey="Gillard, Paul" sort="Gillard, Paul" uniqKey="Gillard P" first="Paul" last="Gillard">Paul Gillard</name><affiliation><hal:affiliation type="institution" xml:id="struct-209482" status="VALID"> <orgName>GlaxoSmithKline Vaccines [Wavre]</orgName> <desc> <address> <addrLine>Avenue Fleming 20, 1300 Wavre</addrLine> <country key="BE"></country> </address> </desc> </hal:affiliation></affiliation></author></analytic><idno type="DOI">10.1186/1471-2334-12-162</idno><series><title level="j">BMC Infectious Diseases</title><idno type="ISSN">1471-2334</idno><imprint><date type="datePub">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="mix" xml:lang="en"><term>CROSS-PROTECTION</term><term>IMMUNITY</term><term>IMMUNOGENICITY</term><term>SAFETY</term><term>VIRUS</term></keywords><keywords scheme="mix" xml:lang="fr"><term>AS03 ADJUVANT</term><term>PROFILE</term><term>RESPONSES</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"> <p>UNLABELLED: ABSTRACT: BACKGROUND: Flexibility of vaccination schedule and lower antigen content can facilitate pandemic vaccine coverage. We assessed the immune response and safety of AS03-adjuvanted A/California/7/2009 H1N1 pandemic vaccine containing half of the registered adult haemagglutinin (HA) antigen content, administered as a two-dose schedule at intervals of 21 days or 6 months in both young and elderly adults. METHODS: In this open-label randomized trial, healthy adults aged 18-60 years (N = 163) and >60 years (N = 143) received AS03A-adjuvanted A/California/7/2009 H1N1 vaccine containing 1.9 μg HA on Day 0. A second dose was given on Day 21 (n = 177) or Day 182 (n = 106). Haemagglutination-inhibition (HI) antibody responses were analyzed on Days 0, 21, 42, 182, 364 and additionally on Day 203 for subjects vaccinated on Day 182. Solicited and unsolicited adverse events were recorded. RESULTS: The HI antibody response in both age strata 21 days after the first dose met and exceeded all regulatory acceptance criteria although the results suggested a lower response in the older age stratum (geometric mean titres [GMTs] for HI antibodies of 420.5 for subjects aged 18-60 years and 174.4 for those >60 years). A second dose of AS03A adjuvanted A/H1N1/2009 vaccine induced a further increase in antibody titres and the response was similar whether the second dose was administered at 21 days (GMTs of 771.8 for 18-60 years and 400.9 for >60 years) or 6 months (GMTs of 708.3 for 18-60 years and 512.1 for >60 years) following the first dose. Seroprotection rates remained high at 6 months after one dose or two doses while at 12 months rates tended to be higher for the 6 month interval schedule (93.3% for 18-60 years and 80.4% for >60 years) than the 21 day schedule (82.3% for 18-60 years and 50.0% for >60 years). Reactogenicity/safety profiles were similar for both schedules, there was no evidence of an increase in reactogenicity following the second dose. CONCLUSIONS: The results indicate that flexibility in the dosing interval for AS03A adjuvanted vaccine may be possible. Such flexibility could help to reduce the logistic stress on delivery of pandemic vaccination programmes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00975884.</p> </div></front></TEI><hal api="V3"> <titleStmt> <title xml:lang="en">Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial.</title> <author role="crp"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <email type="md5">9b28f7a5ea1b2abe59e3e0af156b5172</email> <email type="domain">bch.aphp.fr</email> <idno type="halauthorid">381331</idno> <affiliation ref="#struct-3096"></affiliation> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Adrian</forename> <surname>Caplanusi</surname> </persName> <email type="md5">724fdeab7f932ff6629a462a296a94f0</email> <email type="domain">gskbio.com</email> <idno type="halauthorid">795927</idno> <affiliation ref="#struct-209482"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Henri</forename> <surname>Laurichesse</surname> </persName> <email type="md5">631d2b00c9da0afce4de24425b11a303</email> <email type="domain">chu-clermontferrand.fr</email> <idno type="halauthorid">795928</idno> <affiliation ref="#struct-195699"></affiliation> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Dominique</forename> <surname>Deplanque</surname> </persName> <email type="md5">6d0624bf587aac111d181b409d8acc6f</email> <email type="domain">univ-lille2.fr</email> <idno type="halauthorid">795929</idno> <affiliation ref="#struct-2617"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Pierre</forename> <surname>Loulergue</surname> </persName> <email type="md5">b675279121a4e0a35a980e38a3253478</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">795930</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Tejaswini</forename> <surname>Vaman</surname> </persName> <email type="md5">8aa1e8e7a00a04e7b3a70aa403a6b3bc</email> <email type="domain">gmail.com</email> <idno type="halauthorid">795931</idno> <affiliation ref="#struct-209488"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Paul</forename> <surname>Gillard</surname> </persName> <email type="md5">ecfac816d69ace233d085763ef7b8dea</email> <email type="domain">gskbio.com</email> <idno type="halauthorid">795932</idno> <affiliation ref="#struct-209482"></affiliation> </author> <editor role="depositor"> <persName> <forename>Ed.</forename> <surname>BMC</surname> </persName> <email type="md5">440c6e58a5bd861e373d54bc5e68a1a4</email> <email type="domain">biomedcentral.com</email> </editor> <funder>GSK Biologicals SA</funder> </titleStmt> <editionStmt> <edition n="v1" type="current"> <date type="whenSubmitted">2012-12-14 09:05:58</date> <date type="whenModified">2020-05-28 21:22:17</date> <date type="whenReleased">2012-12-18 12:19:20</date> <date type="whenProduced">2012</date> <date type="whenEndEmbargoed">2012-12-14</date> <ref type="file" target="https://www.hal.inserm.fr/inserm-00765023/document"> <date notBefore="2012-12-14"></date> </ref> <ref type="file" subtype="greenPublisher" n="1" target="https://www.hal.inserm.fr/inserm-00765023/file/1471-2334-12-162.pdf"> <date notBefore="2012-12-14"></date> </ref> <ref type="annex" subtype="other" n="0" target="https://www.hal.inserm.fr/inserm-00765023/file/1471-2334-12-162-S1.PDF"> <date notBefore="2012-12-14"></date> </ref> <ref type="annex" subtype="other" n="0" target="https://www.hal.inserm.fr/inserm-00765023/file/1471-2334-12-162.xml"> <date notBefore="2012-12-14"></date> </ref> <ref type="externalLink" target="https://bmcinfectdis.biomedcentral.com/track/pdf/10.1186/1471-2334-12-162"></ref> </edition> <respStmt> <resp>contributor</resp> <name key="151596"> <persName> <forename>Ed.</forename> <surname>BMC</surname> </persName> <email type="md5">440c6e58a5bd861e373d54bc5e68a1a4</email> <email type="domain">biomedcentral.com</email> </name> </respStmt> </editionStmt> <publicationStmt> <distributor>CCSD</distributor> <idno type="halId">inserm-00765023</idno> <idno type="halUri">https://www.hal.inserm.fr/inserm-00765023</idno> <idno type="halBibtex">duval:inserm-00765023</idno> <idno type="halRefHtml">BMC Infectious Diseases, BioMed Central, 2012, 12 (1), pp.162. ⟨10.1186/1471-2334-12-162⟩</idno> <idno type="halRef">BMC Infectious Diseases, BioMed Central, 2012, 12 (1), pp.162. ⟨10.1186/1471-2334-12-162⟩</idno> </publicationStmt> <seriesStmt> <idno type="stamp" n="INSERM">INSERM - Institut national de la santé et de la recherche médicale</idno> <idno type="stamp" n="UNIV-PARIS7" corresp="UNIV-PARIS">Université Denis Diderot - Paris VII</idno> <idno type="stamp" n="PRES_CLERMONT">Université de Clermont</idno> <idno type="stamp" n="UNIV-CLERMONT1" corresp="PRES_CLERMONT">Université d'Auvergne - Clermont-Ferrand I</idno> <idno type="stamp" n="UNH" corresp="PRES_CLERMONT">Unité de Nutrition Humaine</idno> <idno type="stamp" n="ACL-SVSAE" corresp="PRES_CLERMONT">ACL en SVSAE</idno> <idno type="stamp" n="INRA">INRA - Institut national de la recherche agronomique</idno> <idno type="stamp" n="APHP" corresp="INSERM">AP-HP</idno> <idno type="stamp" n="USPC">Université Sorbonne Paris Cité</idno> <idno type="stamp" n="AGREENIUM">Archive ouverte en agrobiosciences</idno> <idno type="stamp" n="INRAE">Institut National de Recherche en Agriculture, Alimentation et Environnement</idno> <idno type="stamp" n="UNIV-PARIS">Université de Paris</idno> </seriesStmt> <notesStmt> <note type="audience" n="2">International</note> <note type="popular" n="0">No</note> <note type="peer" n="1">Yes</note> </notesStmt> <sourceDesc> <biblStruct> <analytic> <title xml:lang="en">Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial.</title> <author role="crp"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <email type="md5">9b28f7a5ea1b2abe59e3e0af156b5172</email> <email type="domain">bch.aphp.fr</email> <idno type="halauthorid">381331</idno> <affiliation ref="#struct-3096"></affiliation> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Adrian</forename> <surname>Caplanusi</surname> </persName> <email type="md5">724fdeab7f932ff6629a462a296a94f0</email> <email type="domain">gskbio.com</email> <idno type="halauthorid">795927</idno> <affiliation ref="#struct-209482"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Henri</forename> <surname>Laurichesse</surname> </persName> <email type="md5">631d2b00c9da0afce4de24425b11a303</email> <email type="domain">chu-clermontferrand.fr</email> <idno type="halauthorid">795928</idno> <affiliation ref="#struct-195699"></affiliation> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Dominique</forename> <surname>Deplanque</surname> </persName> <email type="md5">6d0624bf587aac111d181b409d8acc6f</email> <email type="domain">univ-lille2.fr</email> <idno type="halauthorid">795929</idno> <affiliation ref="#struct-2617"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Pierre</forename> <surname>Loulergue</surname> </persName> <email type="md5">b675279121a4e0a35a980e38a3253478</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">795930</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Tejaswini</forename> <surname>Vaman</surname> </persName> <email type="md5">8aa1e8e7a00a04e7b3a70aa403a6b3bc</email> <email type="domain">gmail.com</email> <idno type="halauthorid">795931</idno> <affiliation ref="#struct-209488"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Paul</forename> <surname>Gillard</surname> </persName> <email type="md5">ecfac816d69ace233d085763ef7b8dea</email> <email type="domain">gskbio.com</email> <idno type="halauthorid">795932</idno> <affiliation ref="#struct-209482"></affiliation> </author> </analytic> <monogr> <idno type="halJournalId" status="VALID">337</idno> <idno type="issn">1471-2334</idno> <idno type="eissn">1471-2334</idno> <title level="j">BMC Infectious Diseases</title> <imprint> <publisher>BioMed Central</publisher> <biblScope unit="volume">12</biblScope> <biblScope unit="issue">1</biblScope> <biblScope unit="pp">162</biblScope> <date type="datePub">2012</date> <date type="dateEpub">2012-07-23</date> </imprint> </monogr> <idno type="doi">10.1186/1471-2334-12-162</idno> <idno type="prodinra">214504</idno> <idno type="pubmed">22824474</idno> <idno type="wos">000312371100001</idno> </biblStruct> </sourceDesc> <profileDesc> <langUsage> <language ident="en">English</language> </langUsage> <textClass> <keywords scheme="author"> <term xml:lang="en">CROSS-PROTECTION</term> <term xml:lang="en">VIRUS</term> <term xml:lang="en">SAFETY</term> <term xml:lang="en">IMMUNOGENICITY</term> <term xml:lang="en">IMMUNITY</term> <term xml:lang="fr">AS03 ADJUVANT</term> <term xml:lang="fr">RESPONSES</term> <term xml:lang="fr">PROFILE</term> </keywords> <classCode scheme="halDomain" n="sdv.mhep.mi">Life Sciences [q-bio]/Human health and pathology/Infectious diseases</classCode> <classCode scheme="halTypology" n="ART">Journal articles</classCode> </textClass> <abstract xml:lang="en"> <p>UNLABELLED: ABSTRACT: BACKGROUND: Flexibility of vaccination schedule and lower antigen content can facilitate pandemic vaccine coverage. We assessed the immune response and safety of AS03-adjuvanted A/California/7/2009 H1N1 pandemic vaccine containing half of the registered adult haemagglutinin (HA) antigen content, administered as a two-dose schedule at intervals of 21 days or 6 months in both young and elderly adults. METHODS: In this open-label randomized trial, healthy adults aged 18-60 years (N = 163) and >60 years (N = 143) received AS03A-adjuvanted A/California/7/2009 H1N1 vaccine containing 1.9 μg HA on Day 0. A second dose was given on Day 21 (n = 177) or Day 182 (n = 106). Haemagglutination-inhibition (HI) antibody responses were analyzed on Days 0, 21, 42, 182, 364 and additionally on Day 203 for subjects vaccinated on Day 182. Solicited and unsolicited adverse events were recorded. RESULTS: The HI antibody response in both age strata 21 days after the first dose met and exceeded all regulatory acceptance criteria although the results suggested a lower response in the older age stratum (geometric mean titres [GMTs] for HI antibodies of 420.5 for subjects aged 18-60 years and 174.4 for those >60 years). A second dose of AS03A adjuvanted A/H1N1/2009 vaccine induced a further increase in antibody titres and the response was similar whether the second dose was administered at 21 days (GMTs of 771.8 for 18-60 years and 400.9 for >60 years) or 6 months (GMTs of 708.3 for 18-60 years and 512.1 for >60 years) following the first dose. Seroprotection rates remained high at 6 months after one dose or two doses while at 12 months rates tended to be higher for the 6 month interval schedule (93.3% for 18-60 years and 80.4% for >60 years) than the 21 day schedule (82.3% for 18-60 years and 50.0% for >60 years). Reactogenicity/safety profiles were similar for both schedules, there was no evidence of an increase in reactogenicity following the second dose. CONCLUSIONS: The results indicate that flexibility in the dosing interval for AS03A adjuvanted vaccine may be possible. Such flexibility could help to reduce the logistic stress on delivery of pandemic vaccination programmes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00975884.</p> </abstract> </profileDesc> </hal></record>Pour manipuler ce document sous Unix (Dilib)
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