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<title 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>
<creator>Launay, Odile</creator>
<creator>Desaint, Corinne</creator>
<creator>Durier, Christine</creator>
<creator>Loulergue, Pierre</creator>
<creator>Duval, Xavier</creator>
<creator>Jacomet, Christine</creator>
<creator>Pialoux, Gilles</creator>
<creator>Ghosn, Jade</creator>
<creator>Raffi, François</creator>
<creator>Rey, David</creator>
<creator>Ajana, Faiza</creator>
<creator>Colin De Verdière, Nathalie</creator>
<creator>Reynes, Jacques</creator>
<creator>Foubert, Valérie</creator>
<creator>Roman, François</creator>
<creator>Devaster, Jeanne-Marie</creator>
<creator>Delfraissy, Jean-François</creator>
<creator>Aboulker, Jean-Pierre</creator>
<creator>Michelet, Christian</creator>
<contributor>CIC - Biotherapie - AP-HP (cochin - Pasteur) ; Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Essais Therapeutiques et Infection Par Le Vih ; Université Paris-Sud - Paris 11 (UP11) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>CIC - CHU Bichat ; Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>CIC - Clermont Ferrand ; Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Service de médecine interne et maladies infectieuses ; Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bicêtre</contributor>
<contributor>Maladies infectieuses et tropicales</contributor>
<contributor>Service des Maladies Infectieuses et Tropicales ; Assistance publique - Hôpitaux de Paris (AP-HP) - Groupe Hospitalier Saint-Louis-Lariboisière- Fernand-Widal - Université Paris Diderot - Paris 7 (UPD7)</contributor>
<contributor>Département des Maladies Infectieuses et Tropicales ; Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) - Hôpital Gui de Chauliac - UMI 233</contributor>
<contributor>Institut de recherche, santé, environnement et travail [Rennes] (Irset) ; Université d'Angers (UA) - Université des Antilles et de la Guyane (UAG) - Université de Rennes 1 (UR1) - École des Hautes Études en Santé Publique [EHESP] (EHESP) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )</contributor>
<description>International audience</description>
<source>ISSN: 0022-1899</source>
<source>EISSN: 1537-6613</source>
<source>Journal of Infectious Diseases</source>
<publisher>Oxford University Press (OUP)</publisher>
<identifier>hal-00875299</identifier>
<identifier>https://hal.archives-ouvertes.fr/hal-00875299</identifier>
<source>https://hal.archives-ouvertes.fr/hal-00875299</source>
<source>Journal of Infectious Diseases, Oxford University Press (OUP), 2011, 204 (1), pp.124-34. 〈10.1093/infdis/jir211〉</source>
<identifier>DOI : 10.1093/infdis/jir211</identifier>
<relation>info:eu-repo/semantics/altIdentifier/doi/10.1093/infdis/jir211</relation>
<identifier>PUBMED : 21628666</identifier>
<relation>info:eu-repo/semantics/altIdentifier/pmid/21628666</relation>
<language>en</language>
<subject>[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases</subject>
<type>info:eu-repo/semantics/article</type>
<type>Journal articles</type>
<description lang=en>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.</description>
<contributor>ANRS 151 HIFLUVAC Study Group and the French Clinical Vaccinology Network (Réseau National d'Investigation Clinique en Vaccinologie REIVAC)</contributor>
<date>2011-07-01</date>
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