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 : 000176 ( France/Analysis ); précédent : 000175; suivant : 000177Safety 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.
Url:
DOI: 10.1093/infdis/jir211
Affiliations:
- France
- Languedoc-Roussillon, Occitanie (région administrative), Pays de la Loire, Région Bretagne
- Angers, Montpellier, Rennes
- PRES Sud de France, Université Montpellier 1, Université d'Angers, Université de Rennes 1, Université européenne de Bretagne
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Hal:hal-00875299Le document en format XML
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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. 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></titleStmt><publicationStmt><idno type="wicri:source">HAL</idno><idno type="RBID">Hal:hal-00875299</idno><idno type="halId">hal-00875299</idno><idno type="halUri">https://hal.archives-ouvertes.fr/hal-00875299</idno><idno type="url">https://hal.archives-ouvertes.fr/hal-00875299</idno><idno type="doi">10.1093/infdis/jir211</idno><date when="2011-07-01">2011-07-01</date><idno type="wicri:Area/Hal/Corpus">000259</idno><idno type="wicri:Area/Hal/Curation">000259</idno><idno type="wicri:Area/Hal/Checkpoint">000226</idno><idno type="wicri:explorRef" wicri:stream="Hal" wicri:step="Checkpoint">000226</idno><idno type="wicri:doubleKey">0022-1899:2011:Launay O:safety:and:immunogenicity</idno><idno type="wicri:Area/Main/Merge">000B75</idno><idno type="wicri:Area/Main/Curation">000B71</idno><idno type="wicri:Area/Main/Exploration">000B71</idno><idno type="wicri:Area/France/Extraction">000176</idno></publicationStmt><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><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</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="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 - 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CS 19044 - 34967 Montpellier cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.univ-montp1.fr/</ref> </desc> </org></tutelle><tutelle active="#struct-301776" type="direct"><org type="institution" xml:id="struct-301776" status="VALID"> <orgName>Université Cheikh Anta Diop [Dakar, Sénégal]</orgName> <orgName type="acronym">UCAD</orgName> <desc> <address> <addrLine>Dakar</addrLine> <country key="SN"></country> </address> <ref type="url">https://www.ucad.sn/</ref> </desc> </org></tutelle><tutelle active="#struct-301778" type="direct"><org type="institution" xml:id="struct-301778" status="VALID"> <orgName>Universtié Yaoundé 1 [Cameroun]</orgName> <desc> <address> <country key="CM"></country> </address> </desc> </org></tutelle><tutelle active="#struct-410122" type="direct"><org type="institution" xml:id="struct-410122" status="VALID"> <idno type="ISNI">0000000120970141</idno> <orgName>Université de Montpellier</orgName> <orgName type="acronym">UM</orgName> <desc> <address> <addrLine>163 rue Auguste Broussonnet - 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><affiliations><list><country><li>France</li></country><region><li>Languedoc-Roussillon</li><li>Occitanie (région administrative)</li><li>Pays de la Loire</li><li>Région Bretagne</li></region><settlement><li>Angers</li><li>Montpellier</li><li>Rennes</li></settlement><orgName><li>PRES Sud de France</li><li>Université Montpellier 1</li><li>Université d'Angers</li><li>Université de Rennes 1</li><li>Université européenne de Bretagne</li></orgName></list><tree><noCountry><name sortKey="Ajana, Faiza" sort="Ajana, Faiza" uniqKey="Ajana F" first="Faiza" last="Ajana">Faiza Ajana</name><name sortKey="Devaster, Jeanne Marie" sort="Devaster, Jeanne Marie" uniqKey="Devaster J" first="Jeanne-Marie" last="Devaster">Jeanne-Marie Devaster</name><name sortKey="Pialoux, Gilles" sort="Pialoux, Gilles" uniqKey="Pialoux G" first="Gilles" last="Pialoux">Gilles Pialoux</name><name sortKey="Rey, David" sort="Rey, David" uniqKey="Rey D" first="David" last="Rey">David Rey</name><name sortKey="Roman, Francois" sort="Roman, Francois" uniqKey="Roman F" first="François" last="Roman">François Roman</name></noCountry><country name="France"><noRegion><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name></noRegion><name sortKey="Aboulker, Jean Pierre" sort="Aboulker, Jean Pierre" uniqKey="Aboulker J" first="Jean-Pierre" last="Aboulker">Jean-Pierre Aboulker</name><name sortKey="Colin De Verdiere, Nathalie" sort="Colin De Verdiere, Nathalie" uniqKey="Colin De Verdiere N" first="Nathalie" last="Colin De Verdière">Nathalie Colin De Verdière</name><name sortKey="Delfraissy, Jean Francois" sort="Delfraissy, Jean Francois" uniqKey="Delfraissy J" first="Jean-François" last="Delfraissy">Jean-François Delfraissy</name><name sortKey="Desaint, Corinne" sort="Desaint, Corinne" uniqKey="Desaint C" first="Corinne" last="Desaint">Corinne Desaint</name><name sortKey="Durier, Christine" sort="Durier, Christine" uniqKey="Durier C" first="Christine" last="Durier">Christine Durier</name><name sortKey="Duval, Xavier" sort="Duval, Xavier" uniqKey="Duval X" first="Xavier" last="Duval">Xavier Duval</name><name sortKey="Foubert, Valerie" sort="Foubert, Valerie" uniqKey="Foubert V" first="Valérie" last="Foubert">Valérie Foubert</name><name sortKey="Ghosn, Jade" sort="Ghosn, Jade" uniqKey="Ghosn J" first="Jade" last="Ghosn">Jade Ghosn</name><name sortKey="Jacomet, Christine" sort="Jacomet, Christine" uniqKey="Jacomet C" first="Christine" last="Jacomet">Christine Jacomet</name><name sortKey="Loulergue, Pierre" sort="Loulergue, Pierre" uniqKey="Loulergue P" first="Pierre" last="Loulergue">Pierre Loulergue</name><name sortKey="Michelet, Christian" sort="Michelet, Christian" uniqKey="Michelet C" first="Christian" last="Michelet">Christian Michelet</name><name sortKey="Raffi, Francois" sort="Raffi, Francois" uniqKey="Raffi F" first="François" last="Raffi">François Raffi</name><name sortKey="Reynes, Jacques" sort="Reynes, Jacques" uniqKey="Reynes J" first="Jacques" last="Reynes">Jacques Reynes</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.
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