Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.
Identifieur interne : 000226 ( Hal/Checkpoint ); précédent : 000225; suivant : 000227Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.
Auteurs : Odile Launay [France] ; Corinne Desaint [France] ; Christine Durier [France] ; Pierre Loulergue [France] ; Xavier Duval [France] ; Christine Jacomet [France] ; Gilles Pialoux ; Jade Ghosn [France] ; François Raffi [France] ; David Rey ; Faiza Ajana ; Nathalie Colin De Verdière [France] ; Jacques Reynes [France] ; Valérie Foubert [France] ; François Roman ; Jeanne-Marie Devaster ; Jean-François Delfraissy [France] ; Jean-Pierre Aboulker [France] ; Christian Michelet [France]Source :
- Journal of Infectious Diseases [ 0022-1899 ] ; 2011-07-01.
Abstract
BACKGROUND: Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population. METHODS: We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 μg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 μg HA to assess hemagglutination inhibition (HI) response and safety. RESULTS: A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥1:40 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected. CONCLUSIONS: In HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.
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DOI: 10.1093/infdis/jir211
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40 Rue de Rennes, BP 73532 - 49035 Angers CEDEX 01</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-angers.fr/</ref> </desc> </org></tutelle><tutelle active="#struct-105160" type="direct"><org type="institution" xml:id="struct-105160" status="VALID"> <orgName>Université de Rennes 1</orgName> <orgName type="acronym">UR1</orgName> <desc> <address> <addrLine>2 rue du Thabor - CS 46510 - 35065 Rennes cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-rennes1.fr/</ref> </desc> <listRelation> <relation active="#struct-528860" type="direct"></relation> </listRelation> </org></tutelle><tutelle active="#struct-528860" type="indirect"><org type="regroupinstitution" xml:id="struct-528860" status="VALID"> <orgName>Université de Rennes</orgName> <orgName type="acronym">UNIV-RENNES</orgName> <date type="start">2018-01-01</date> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-301986" type="direct"><org type="institution" xml:id="struct-301986" status="VALID"> <orgName>École des Hautes Études en Santé Publique [EHESP]</orgName> <orgName type="acronym">EHESP</orgName> <date type="start">2016-06-20</date> <desc> <address> <addrLine>15, avenue du Pr. 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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><country>France</country></affiliation></author><author><name sortKey="Desaint, Corinne" sort="Desaint, Corinne" uniqKey="Desaint C" first="Corinne" last="Desaint">Corinne Desaint</name><affiliation wicri:level="1"><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><country>France</country></affiliation></author><author><name sortKey="Durier, Christine" sort="Durier, Christine" uniqKey="Durier C" first="Christine" last="Durier">Christine Durier</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2794" status="OLD"> <orgName>Essais Therapeutiques et Infection Par Le Vih</orgName> <date type="end">2012</date> <desc> <address> <addrLine>Centre de Recherche Inserm PARIS XI 16, Avenue Paul Vaillant-Couturier 94807 VILLEJUIF CEDEX</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-92966" type="direct"></relation> <relation name="SC10" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-92966" type="direct"><org type="institution" xml:id="struct-92966" status="VALID"> <orgName>Université Paris-Sud - Paris 11</orgName> <orgName type="acronym">UP11</orgName> <desc> <address> <addrLine>Bâtiment 300 - 91405 Orsay cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.u-psud.fr/</ref> </desc> </org></tutelle><tutelle name="SC10" 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><country>France</country></affiliation></author><author><name sortKey="Loulergue, Pierre" sort="Loulergue, Pierre" uniqKey="Loulergue P" first="Pierre" last="Loulergue">Pierre Loulergue</name><affiliation wicri:level="1"><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><country>France</country></affiliation></author><author><name sortKey="Duval, Xavier" sort="Duval, Xavier" uniqKey="Duval X" first="Xavier" last="Duval">Xavier Duval</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2607" status="VALID"> <orgName>CIC - CHU Bichat</orgName> <desc> <address> <addrLine>Gh Xavier Bichat - Claude Bernard PARIS VII 46, Rue Henri Huchard 75018 PARIS</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CIC7" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CIC7" 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><country>France</country></affiliation></author><author><name sortKey="Jacomet, Christine" sort="Jacomet, Christine" uniqKey="Jacomet C" first="Christine" last="Jacomet">Christine Jacomet</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2612" status="VALID"> <orgName>CIC - Clermont Ferrand</orgName> <desc> <address> <addrLine>Chu Clermont Ferrand LYON 58, Rue Montalembert 63003 CLERMONT FERRAND CEDEX 1</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CIC501" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CIC501" 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><country>France</country></affiliation></author><author><name sortKey="Pialoux, Gilles" sort="Pialoux, Gilles" uniqKey="Pialoux G" first="Gilles" last="Pialoux">Gilles Pialoux</name></author><author><name sortKey="Ghosn, Jade" sort="Ghosn, Jade" uniqKey="Ghosn J" first="Jade" last="Ghosn">Jade Ghosn</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-33891" status="VALID"> <orgName>Service de médecine interne et maladies infectieuses</orgName> <desc> <address> <addrLine>Le Kremlin-Bicêtre</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-92966" type="direct"></relation> <relation active="#struct-300068" type="direct"></relation> <relation active="#struct-300148" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-92966" type="direct"><org type="institution" xml:id="struct-92966" status="VALID"> <orgName>Université Paris-Sud - 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34090 Montpellier</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.umontpellier.fr/</ref> </desc> </org></tutelle></tutelles></hal:affiliation><country>France</country><placeName><settlement type="city">Montpellier</settlement><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region></placeName><orgName type="university">Université Montpellier 1</orgName><orgName type="institution" wicri:auto="newGroup">PRES Sud de France</orgName></affiliation></author><author><name sortKey="Foubert, Valerie" sort="Foubert, Valerie" uniqKey="Foubert V" first="Valérie" last="Foubert">Valérie Foubert</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2794" status="OLD"> <orgName>Essais Therapeutiques et Infection Par Le Vih</orgName> <date type="end">2012</date> <desc> <address> <addrLine>Centre de Recherche Inserm PARIS XI 16, Avenue Paul Vaillant-Couturier 94807 VILLEJUIF CEDEX</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-92966" type="direct"></relation> <relation name="SC10" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-92966" type="direct"><org type="institution" xml:id="struct-92966" status="VALID"> <orgName>Université Paris-Sud - Paris 11</orgName> <orgName type="acronym">UP11</orgName> <desc> <address> <addrLine>Bâtiment 300 - 91405 Orsay cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.u-psud.fr/</ref> </desc> </org></tutelle><tutelle name="SC10" 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><country>France</country></affiliation></author><author><name sortKey="Roman, Francois" sort="Roman, Francois" uniqKey="Roman F" first="François" last="Roman">François Roman</name></author><author><name sortKey="Devaster, Jeanne Marie" sort="Devaster, Jeanne Marie" uniqKey="Devaster J" first="Jeanne-Marie" last="Devaster">Jeanne-Marie Devaster</name></author><author><name sortKey="Delfraissy, Jean Francois" sort="Delfraissy, Jean Francois" uniqKey="Delfraissy J" first="Jean-François" last="Delfraissy">Jean-François Delfraissy</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2612" status="VALID"> <orgName>CIC - Clermont Ferrand</orgName> <desc> <address> <addrLine>Chu Clermont Ferrand LYON 58, Rue Montalembert 63003 CLERMONT FERRAND CEDEX 1</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CIC501" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CIC501" 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><country>France</country></affiliation></author><author><name sortKey="Aboulker, Jean Pierre" sort="Aboulker, Jean Pierre" uniqKey="Aboulker J" first="Jean-Pierre" last="Aboulker">Jean-Pierre Aboulker</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2794" status="OLD"> <orgName>Essais Therapeutiques et Infection Par Le Vih</orgName> <date type="end">2012</date> <desc> <address> <addrLine>Centre de Recherche Inserm PARIS XI 16, Avenue Paul Vaillant-Couturier 94807 VILLEJUIF CEDEX</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-92966" type="direct"></relation> <relation name="SC10" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-92966" type="direct"><org type="institution" xml:id="struct-92966" status="VALID"> <orgName>Université Paris-Sud - Paris 11</orgName> <orgName type="acronym">UP11</orgName> <desc> <address> <addrLine>Bâtiment 300 - 91405 Orsay cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.u-psud.fr/</ref> </desc> </org></tutelle><tutelle name="SC10" 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><country>France</country></affiliation></author><author><name sortKey="Michelet, Christian" sort="Michelet, Christian" uniqKey="Michelet C" first="Christian" last="Michelet">Christian Michelet</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-182194" status="VALID"> <idno type="RNSR">201722263E</idno> <orgName>Institut de recherche en santé, environnement et travail</orgName> <orgName type="acronym">Irset</orgName> <desc> <address> <addrLine>263 avenue Général Leclerc 35042 Rennes Cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.irset.org</ref> </desc> <listRelation> <relation active="#struct-74911" type="direct"></relation> <relation active="#struct-105160" type="direct"></relation> <relation active="#struct-528860" type="indirect"></relation> <relation active="#struct-301986" type="direct"></relation> <relation name="U1085" active="#struct-303623" type="direct"></relation> <relation active="#struct-453207" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-74911" type="direct"><org type="institution" xml:id="struct-74911" status="VALID"> <idno type="IdRef">026402920</idno> <idno type="ISNI">0000000122483363</idno> <orgName>Université d'Angers</orgName> <orgName type="acronym">UA</orgName> <date type="start">1971-10-25</date> <desc> <address> <addrLine>Université d'Angers - 40 Rue de Rennes, BP 73532 - 49035 Angers CEDEX 01</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-angers.fr/</ref> </desc> </org></tutelle><tutelle active="#struct-105160" type="direct"><org type="institution" xml:id="struct-105160" status="VALID"> <orgName>Université de Rennes 1</orgName> <orgName type="acronym">UR1</orgName> <desc> <address> <addrLine>2 rue du Thabor - CS 46510 - 35065 Rennes cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-rennes1.fr/</ref> </desc> <listRelation> <relation active="#struct-528860" type="direct"></relation> </listRelation> </org></tutelle><tutelle active="#struct-528860" type="indirect"><org type="regroupinstitution" xml:id="struct-528860" status="VALID"> <orgName>Université de Rennes</orgName> <orgName type="acronym">UNIV-RENNES</orgName> <date type="start">2018-01-01</date> <desc> <address> <country key="FR"></country> </address> </desc> </org></tutelle><tutelle active="#struct-301986" type="direct"><org type="institution" xml:id="struct-301986" status="VALID"> <orgName>École des Hautes Études en Santé Publique [EHESP]</orgName> <orgName type="acronym">EHESP</orgName> <date type="start">2016-06-20</date> <desc> <address> <addrLine>15, avenue du Pr. Léon Bernard - 35043 Rennes Cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.ehesp.fr/</ref> </desc> </org></tutelle><tutelle name="U1085" 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-453207" type="direct"><org type="institution" xml:id="struct-453207" status="VALID"> <orgName>Structure Fédérative de Recherche en Biologie et Santé de Rennes </orgName> <orgName type="acronym"> Biosit : Biologie - Santé - Innovation Technologique </orgName> <desc> <address> <addrLine>Université Rennes 1 - Campus Santé Villejean - 2, avenue Professeur Léon Bernard 35043 Rennes cedex</addrLine> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation><country>France</country><placeName><settlement type="city">Angers</settlement><region type="region" nuts="2">Pays de la Loire</region></placeName><orgName type="university">Université d'Angers</orgName><placeName><settlement type="city">Rennes</settlement><region type="region" nuts="2">Région Bretagne</region></placeName><orgName type="university">Université de Rennes 1</orgName><orgName type="institution" wicri:auto="newGroup">Université européenne de Bretagne</orgName></affiliation></author></analytic><idno type="DOI">10.1093/infdis/jir211</idno><series><title level="j">Journal of Infectious Diseases</title><idno type="ISSN">0022-1899</idno><imprint><date type="datePub">2011-07-01</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"> <p>BACKGROUND: Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population. METHODS: We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 μg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 μg HA to assess hemagglutination inhibition (HI) response and safety. RESULTS: A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥1:40 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected. CONCLUSIONS: In HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.</p> </div></front></TEI><hal api="V3"> <titleStmt> <title xml:lang="en">Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.</title> <author role="crp"> <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">Corinne</forename> <surname>Desaint</surname> </persName> <idno type="halauthorid">707355</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christine</forename> <surname>Durier</surname> </persName> <idno type="halauthorid">707354</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Pierre</forename> <surname>Loulergue</surname> </persName> <idno type="halauthorid">902103</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <idno type="halauthorid">203676</idno> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christine</forename> <surname>Jacomet</surname> </persName> <idno type="halauthorid">902010</idno> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Gilles</forename> <surname>Pialoux</surname> </persName> <idno type="halauthorid">422826</idno> </author> <author role="aut"> <persName> <forename type="first">Jade</forename> <surname>Ghosn</surname> </persName> <idno type="halauthorid">705124</idno> <affiliation ref="#struct-33891"></affiliation> </author> <author role="aut"> <persName> <forename type="first">François</forename> <surname>Raffi</surname> </persName> <idno type="halauthorid">88274</idno> <affiliation ref="#struct-178763"></affiliation> </author> <author role="aut"> <persName> <forename type="first">David</forename> <surname>Rey</surname> </persName> <idno type="halauthorid">100700</idno> </author> <author role="aut"> <persName> <forename type="first">Faiza</forename> <surname>Ajana</surname> </persName> <idno type="halauthorid">902104</idno> </author> <author role="aut"> <persName> <forename type="first">Nathalie</forename> <surname>Colin De Verdière</surname> </persName> <idno type="halauthorid">902105</idno> <affiliation ref="#struct-197258"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jacques</forename> <surname>Reynes</surname> </persName> <idno type="halauthorid">609865</idno> <affiliation ref="#struct-160874"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Valérie</forename> <surname>Foubert</surname> </persName> <idno type="halauthorid">902106</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">François</forename> <surname>Roman</surname> </persName> <idno type="halauthorid">901926</idno> </author> <author role="aut"> <persName> <forename type="first">Jeanne-Marie</forename> <surname>Devaster</surname> </persName> <idno type="halauthorid">902107</idno> </author> <author role="aut"> <persName> <forename type="first">Jean-François</forename> <surname>Delfraissy</surname> </persName> <idno type="halauthorid">85735</idno> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jean-Pierre</forename> <surname>Aboulker</surname> </persName> <idno type="halauthorid">707359</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christian</forename> <surname>Michelet</surname> </persName> <idno type="halauthorid">516156</idno> <affiliation ref="#struct-182194"></affiliation> </author> <editor role="depositor"> <persName> <forename>Morgane</forename> <surname>Le Corre</surname> </persName> <email type="md5">8503b29898396526c56d96d8ae07e3e5</email> <email type="domain">univ-rennes1.fr</email> </editor> </titleStmt> <editionStmt> <edition n="v1" type="current"> <date type="whenSubmitted">2013-10-21 16:00:36</date> <date type="whenModified">2020-03-28 02:17:52</date> <date type="whenReleased">2013-10-21 16:00:36</date> <date type="whenProduced">2011-07-01</date> <ref type="externalLink" target="https://academic.oup.com/jid/article-pdf/204/1/124/18064872/jir211.pdf"></ref> </edition> <respStmt> <resp>contributor</resp> <name key="186196"> <persName> <forename>Morgane</forename> <surname>Le Corre</surname> </persName> <email type="md5">8503b29898396526c56d96d8ae07e3e5</email> <email type="domain">univ-rennes1.fr</email> </name> </respStmt> </editionStmt> <publicationStmt> <distributor>CCSD</distributor> <idno type="halId">hal-00875299</idno> <idno type="halUri">https://hal.archives-ouvertes.fr/hal-00875299</idno> <idno type="halBibtex">launay:hal-00875299</idno> <idno type="halRefHtml">Journal of Infectious Diseases, Oxford University Press (OUP), 2011, 204 (1), pp.124-34. ⟨10.1093/infdis/jir211⟩</idno> <idno type="halRef">Journal of Infectious Diseases, Oxford University Press (OUP), 2011, 204 (1), pp.124-34. ⟨10.1093/infdis/jir211⟩</idno> </publicationStmt> <seriesStmt> <idno type="stamp" n="UNIV-PARIS7" corresp="UNIV-PARIS">Université Denis Diderot - Paris VII</idno> <idno type="stamp" n="IFR140">SFR Biosit - Biologie et Santé CNRS UMS 3480</idno> <idno type="stamp" n="UNIV-RENNES1">Université de Rennes 1</idno> <idno type="stamp" n="IRSET">Institut de Recherche en Santé, Environnement et Travail</idno> <idno type="stamp" n="APHP" corresp="INSERM">AP-HP</idno> <idno type="stamp" n="IRSET-HIAEC" corresp="IRSET">HEPATOTROPIC INFECTIOUS AGENTS AND ENVIRONMENTAL COFACTORS</idno> <idno type="stamp" n="BIOSIT">SFR Biosit - Biologie et Santé CNRS UMS 3480</idno> <idno type="stamp" n="UR1-UFR-SVE">UFR SVE Sciences de la vie et de l'environnement</idno> <idno type="stamp" n="USPC">Université Sorbonne Paris Cité</idno> <idno type="stamp" n="UR1-HAL">Publications labos UR1 dans HAL-Rennes 1</idno> <idno type="stamp" n="STATS-UR1">Statistiques-HAL-UR1</idno> <idno type="stamp" n="UR1-SDV">UR1 - publications SDV</idno> <idno type="stamp" n="IRSET-2" corresp="IRSET">SAMSON - Infection, immunité, facteurs environnementaux et foie (2IFEF) </idno> <idno type="stamp" n="UNIV-ANGERS">Université d'Angers</idno> <idno type="stamp" n="UNIV-PSUD">Université Paris Sud - Paris XI</idno> <idno type="stamp" n="BS">Biologie-Santé</idno> <idno type="stamp" n="UNIV-MONTPELLIER">Université de Montpellier</idno> <idno type="stamp" n="TEST-UNIV-RENNES">TEST Université de Rennes</idno> <idno type="stamp" n="TEST-UR-CSS">TEST Université de Rennes CSS</idno> <idno type="stamp" n="UNIV-RENNES">Université de Rennes</idno> <idno type="stamp" n="IRSET-SMS" corresp="IRSET">STRESS, MEMBRANE AND SIGNALING</idno> <idno type="stamp" n="IRSET-CCII" corresp="IRSET">CHEMICAL CONTAMINANTS, IMMUNITY AND INFLAMMATION</idno> <idno type="stamp" n="IRSET-TREC" corresp="IRSET">TRANSCRIPTION, ENVIRONMENT and CANCER (TREC)</idno> <idno type="stamp" n="IRSET-SMLF" corresp="IRSET">SIGNALING AND MODELING IN LIVER FIBROSIS</idno> <idno type="stamp" n="IRSET-ERD" corresp="IRSET">EPIDEMIOLOGICAL RESEARCH ON ENVIRONMENT, REPRODUCTION AND DEVELOPMENT</idno> <idno type="stamp" n="IRSET-VCER" corresp="IRSET">ENVIRONMENT VIRAL ET CHIMIQUE & REPRODUCTION</idno> <idno type="stamp" n="IRSET-NEED" corresp="IRSET">NEUROENDOCRINE EFFECTS OF ENDOCRINE DISRUPTORS</idno> <idno type="stamp" n="IRSET-TNGC" corresp="IRSET">Recherches épidémiologiques sur l'environnement, la reproduction et le développement</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">Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.</title> <author role="crp"> <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">Corinne</forename> <surname>Desaint</surname> </persName> <idno type="halauthorid">707355</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christine</forename> <surname>Durier</surname> </persName> <idno type="halauthorid">707354</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Pierre</forename> <surname>Loulergue</surname> </persName> <idno type="halauthorid">902103</idno> <affiliation ref="#struct-2593"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Xavier</forename> <surname>Duval</surname> </persName> <idno type="halauthorid">203676</idno> <affiliation ref="#struct-2607"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christine</forename> <surname>Jacomet</surname> </persName> <idno type="halauthorid">902010</idno> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Gilles</forename> <surname>Pialoux</surname> </persName> <idno type="halauthorid">422826</idno> </author> <author role="aut"> <persName> <forename type="first">Jade</forename> <surname>Ghosn</surname> </persName> <idno type="halauthorid">705124</idno> <affiliation ref="#struct-33891"></affiliation> </author> <author role="aut"> <persName> <forename type="first">François</forename> <surname>Raffi</surname> </persName> <idno type="halauthorid">88274</idno> <affiliation ref="#struct-178763"></affiliation> </author> <author role="aut"> <persName> <forename type="first">David</forename> <surname>Rey</surname> </persName> <idno type="halauthorid">100700</idno> </author> <author role="aut"> <persName> <forename type="first">Faiza</forename> <surname>Ajana</surname> </persName> <idno type="halauthorid">902104</idno> </author> <author role="aut"> <persName> <forename type="first">Nathalie</forename> <surname>Colin De Verdière</surname> </persName> <idno type="halauthorid">902105</idno> <affiliation ref="#struct-197258"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jacques</forename> <surname>Reynes</surname> </persName> <idno type="halauthorid">609865</idno> <affiliation ref="#struct-160874"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Valérie</forename> <surname>Foubert</surname> </persName> <idno type="halauthorid">902106</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">François</forename> <surname>Roman</surname> </persName> <idno type="halauthorid">901926</idno> </author> <author role="aut"> <persName> <forename type="first">Jeanne-Marie</forename> <surname>Devaster</surname> </persName> <idno type="halauthorid">902107</idno> </author> <author role="aut"> <persName> <forename type="first">Jean-François</forename> <surname>Delfraissy</surname> </persName> <idno type="halauthorid">85735</idno> <affiliation ref="#struct-2612"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Jean-Pierre</forename> <surname>Aboulker</surname> </persName> <idno type="halauthorid">707359</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Christian</forename> <surname>Michelet</surname> </persName> <idno type="halauthorid">516156</idno> <affiliation ref="#struct-182194"></affiliation> </author> </analytic> <monogr> <idno type="halJournalId" status="VALID">16582</idno> <idno type="issn">0022-1899</idno> <idno type="eissn">1537-6613</idno> <title level="j">Journal of Infectious Diseases</title> <imprint> <publisher>Oxford University Press (OUP)</publisher> <biblScope unit="volume">204</biblScope> <biblScope unit="issue">1</biblScope> <biblScope unit="pp">124-34</biblScope> <date type="datePub">2011-07-01</date> </imprint> </monogr> <idno type="doi">10.1093/infdis/jir211</idno> <idno type="pubmed">21628666</idno> </biblStruct> </sourceDesc> <profileDesc> <langUsage> <language ident="en">English</language> </langUsage> <textClass> <classCode scheme="mesh">Adjuvants, Immunologic</classCode> <classCode scheme="mesh">Adult</classCode> <classCode scheme="mesh">Male</classCode> <classCode scheme="mesh">Middle Aged</classCode> <classCode scheme="mesh">Squalene</classCode> <classCode scheme="mesh">Antibodies, Viral</classCode> <classCode scheme="mesh">Female</classCode> <classCode scheme="mesh">HIV Infections</classCode> <classCode scheme="mesh">Hemagglutination Inhibition Tests</classCode> <classCode scheme="mesh">Humans</classCode> <classCode scheme="mesh">Influenza A Virus, H1N1 Subtype</classCode> <classCode scheme="mesh">Influenza Vaccines</classCode> <classCode scheme="mesh">Influenza, Human</classCode> <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>BACKGROUND: Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population. METHODS: We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 μg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 μg HA to assess hemagglutination inhibition (HI) response and safety. RESULTS: A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥1:40 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected. CONCLUSIONS: In HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.</p> </abstract> <particDesc> <org type="consortium">ANRS 151 HIFLUVAC Study Group and the French Clinical Vaccinology Network (Réseau National d'Investigation Clinique en Vaccinologie REIVAC)</org> </particDesc> </profileDesc> </hal></record>Pour manipuler ce document sous Unix (Dilib)
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