Strong serological responses and HIV RNA increase following AS03‐adjuvanted pandemic immunization in HIV‐infected patients

Introduction We aimed to determine the antibody responses and effect on viral load of the AS03‐adjuvanted pandemic H1N1 vaccine in HIV‐infected patients. Method A total of 121 HIV‐infected patients and 138 healthy subjects were enrolled in a prospective, open‐label study. Healthy subjects received o...

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Veröffentlicht in:HIV medicine 2012-04, Vol.13 (4), p.207-218
Hauptverfasser: Calmy, A, Bel, M, Nguyen, A, Combescure, C, Delhumeau, C, Meier, S, Yerly, S, Kaiser, L, Hirschel, B, Siegrist, C‐A, Siegrist, C. A., Posfay‐Barbe, K., Meier, S., Bel, M., Grillet, S., Sealy, G., Demeules, J., Charvat, S., Verdon, M., Combescure, C., Hirschel, B., Calmy, A., Nguyen, A., Delhumeau‐Cartier, C., Gabay, C., Guerne, P.A., Seebach, J., Ribi, C., Villard, J., Dietrich, P. Y., George, A. C., Favet, L., Delden, C., Morard, I., Mentha, G., Giostra, E., Hadaya, K., Martin, P. Y., Soccal, P., Berney, T., Noble, S., Mohty, B., Nagy, M., Chalandon, Y., Roosnek, E., Passweg, J., Kaiser, L., Yerly, S., Thomas, Y., Wunderli, W.
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container_end_page 218
container_issue 4
container_start_page 207
container_title HIV medicine
container_volume 13
creator Calmy, A
Bel, M
Nguyen, A
Combescure, C
Delhumeau, C
Meier, S
Yerly, S
Kaiser, L
Hirschel, B
Siegrist, C‐A
Siegrist, C. A.
Posfay‐Barbe, K.
Meier, S.
Bel, M.
Grillet, S.
Sealy, G.
Demeules, J.
Charvat, S.
Verdon, M.
Combescure, C.
Hirschel, B.
Calmy, A.
Nguyen, A.
Delhumeau‐Cartier, C.
Gabay, C.
Guerne, P.A.
Seebach, J.
Ribi, C.
Villard, J.
Dietrich, P. Y.
George, A. C.
Favet, L.
Delden, C.
Morard, I.
Mentha, G.
Giostra, E.
Hadaya, K.
Martin, P. Y.
Soccal, P.
Berney, T.
Noble, S.
Mohty, B.
Nagy, M.
Chalandon, Y.
Roosnek, E.
Passweg, J.
Kaiser, L.
Yerly, S.
Thomas, Y.
Wunderli, W.
description Introduction We aimed to determine the antibody responses and effect on viral load of the AS03‐adjuvanted pandemic H1N1 vaccine in HIV‐infected patients. Method A total of 121 HIV‐infected patients and 138 healthy subjects were enrolled in a prospective, open‐label study. Healthy subjects received one dose and HIV‐infected patients two doses of the AS03‐adjuvanted split influenza A/09/H1N1 vaccine (Pandemrix®; GlaxoSmithKline, Brentford, United Kingdom.) at an interval of 3–4 weeks. The study was extended in 2010/2011 for 66 patients. Geometric mean titres (GMTs), seroprotection rates (post‐vaccination titre ≥1:40) and HIV‐1 RNA levels were measured before and 4 weeks after immunization. Results After two immunizations, the seroprotection rate (94.2 vs. 87%, respectively) and GMT (376 vs. 340, respectively) in HIV‐infected patients were as high as in healthy subjects after one dose, regardless of CD4 cell count. Four weeks after immunization, HIV RNA was detected in plasma samples from 40 of 68 (58.0%) previously aviraemic patients [median 152 HIV‐1 RNA copies/mL; interquartile range (IQR) 87–509 copies/mL]. Subsequent measures indicated that HIV RNA levels had again declined to
doi_str_mv 10.1111/j.1468-1293.2011.00961.x
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A. ; Posfay‐Barbe, K. ; Meier, S. ; Bel, M. ; Grillet, S. ; Sealy, G. ; Demeules, J. ; Charvat, S. ; Verdon, M. ; Combescure, C. ; Hirschel, B. ; Calmy, A. ; Nguyen, A. ; Delhumeau‐Cartier, C. ; Gabay, C. ; Guerne, P.A. ; Seebach, J. ; Ribi, C. ; Villard, J. ; Dietrich, P. Y. ; George, A. C. ; Favet, L. ; Delden, C. ; Morard, I. ; Mentha, G. ; Giostra, E. ; Hadaya, K. ; Martin, P. Y. ; Soccal, P. ; Berney, T. ; Noble, S. ; Mohty, B. ; Nagy, M. ; Chalandon, Y. ; Roosnek, E. ; Passweg, J. ; Kaiser, L. ; Yerly, S. ; Thomas, Y. ; Wunderli, W.</creator><creatorcontrib>Calmy, A ; Bel, M ; Nguyen, A ; Combescure, C ; Delhumeau, C ; Meier, S ; Yerly, S ; Kaiser, L ; Hirschel, B ; Siegrist, C‐A ; Siegrist, C. A. ; Posfay‐Barbe, K. ; Meier, S. ; Bel, M. ; Grillet, S. ; Sealy, G. ; Demeules, J. ; Charvat, S. ; Verdon, M. ; Combescure, C. ; Hirschel, B. ; Calmy, A. ; Nguyen, A. ; Delhumeau‐Cartier, C. ; Gabay, C. ; Guerne, P.A. ; Seebach, J. ; Ribi, C. ; Villard, J. ; Dietrich, P. Y. ; George, A. C. ; Favet, L. ; Delden, C. ; Morard, I. ; Mentha, G. ; Giostra, E. ; Hadaya, K. ; Martin, P. Y. ; Soccal, P. ; Berney, T. ; Noble, S. ; Mohty, B. ; Nagy, M. ; Chalandon, Y. ; Roosnek, E. ; Passweg, J. ; Kaiser, L. ; Yerly, S. ; Thomas, Y. ; Wunderli, W. ; H1N1 Study Group</creatorcontrib><description>Introduction We aimed to determine the antibody responses and effect on viral load of the AS03‐adjuvanted pandemic H1N1 vaccine in HIV‐infected patients. Method A total of 121 HIV‐infected patients and 138 healthy subjects were enrolled in a prospective, open‐label study. Healthy subjects received one dose and HIV‐infected patients two doses of the AS03‐adjuvanted split influenza A/09/H1N1 vaccine (Pandemrix®; GlaxoSmithKline, Brentford, United Kingdom.) at an interval of 3–4 weeks. The study was extended in 2010/2011 for 66 patients. Geometric mean titres (GMTs), seroprotection rates (post‐vaccination titre ≥1:40) and HIV‐1 RNA levels were measured before and 4 weeks after immunization. Results After two immunizations, the seroprotection rate (94.2 vs. 87%, respectively) and GMT (376 vs. 340, respectively) in HIV‐infected patients were as high as in healthy subjects after one dose, regardless of CD4 cell count. Four weeks after immunization, HIV RNA was detected in plasma samples from 40 of 68 (58.0%) previously aviraemic patients [median 152 HIV‐1 RNA copies/mL; interquartile range (IQR) 87–509 copies/mL]. Subsequent measures indicated that HIV RNA levels had again declined to &lt;20 copies/mL in most patients (27 of 34; 79.4%). Following (nonadjuvanted) influenza immunization in 2010/2011, HIV RNA levels only slightly increased (median final level 28 copies/mL) in three of 66 (4.5%) previously aviraemic patients, including two of 25 (8%) patients in whom an increase had been elicited by AS03‐adjuvanted vaccine the year before. Conclusion Most HIV‐infected patients developed seroprotection after two doses of AS03‐adjuvanted pandemic vaccine. A transient effect on HIV RNA levels was observed in previously aviraemic patients. A booster dose of the nonadjuvanted influenza vaccine containing the A/09/H1N1 strain the following year did not reproduce this finding, indicating a non‐antigen‐specific adjuvant effect.</description><identifier>ISSN: 1464-2662</identifier><identifier>EISSN: 1468-1293</identifier><identifier>DOI: 10.1111/j.1468-1293.2011.00961.x</identifier><identifier>PMID: 22093373</identifier><language>eng</language><publisher>England</publisher><subject>adjuvanted H1N1 vaccine ; Adjuvants ; Adult ; alpha-Tocopherol - administration &amp; dosage ; alpha-Tocopherol - immunology ; Antibodies ; Antibodies, Viral - blood ; CD4 antigen ; Drug Combinations ; Female ; Hemagglutination Inhibition Tests ; HIV ; HIV Infections - immunology ; HIV Infections - virology ; HIV-1 - isolation &amp; purification ; Human immunodeficiency virus 1 ; Humans ; Immunization ; Influenza A ; Influenza Vaccines - administration &amp; dosage ; Influenza Vaccines - immunology ; Male ; Middle Aged ; pandemics ; Polysorbates - administration &amp; dosage ; Prospective Studies ; RNA ; RNA, Viral - blood ; seroprotection ; Squalene - administration &amp; dosage ; Squalene - immunology ; Vaccines ; viraemia ; Viral Load</subject><ispartof>HIV medicine, 2012-04, Vol.13 (4), p.207-218</ispartof><rights>2011 British HIV Association</rights><rights>2011 British HIV Association.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1468-1293.2011.00961.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1468-1293.2011.00961.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22093373$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Calmy, A</creatorcontrib><creatorcontrib>Bel, M</creatorcontrib><creatorcontrib>Nguyen, A</creatorcontrib><creatorcontrib>Combescure, C</creatorcontrib><creatorcontrib>Delhumeau, C</creatorcontrib><creatorcontrib>Meier, S</creatorcontrib><creatorcontrib>Yerly, S</creatorcontrib><creatorcontrib>Kaiser, L</creatorcontrib><creatorcontrib>Hirschel, B</creatorcontrib><creatorcontrib>Siegrist, C‐A</creatorcontrib><creatorcontrib>Siegrist, C. A.</creatorcontrib><creatorcontrib>Posfay‐Barbe, K.</creatorcontrib><creatorcontrib>Meier, S.</creatorcontrib><creatorcontrib>Bel, M.</creatorcontrib><creatorcontrib>Grillet, S.</creatorcontrib><creatorcontrib>Sealy, G.</creatorcontrib><creatorcontrib>Demeules, J.</creatorcontrib><creatorcontrib>Charvat, S.</creatorcontrib><creatorcontrib>Verdon, M.</creatorcontrib><creatorcontrib>Combescure, C.</creatorcontrib><creatorcontrib>Hirschel, B.</creatorcontrib><creatorcontrib>Calmy, A.</creatorcontrib><creatorcontrib>Nguyen, A.</creatorcontrib><creatorcontrib>Delhumeau‐Cartier, C.</creatorcontrib><creatorcontrib>Gabay, C.</creatorcontrib><creatorcontrib>Guerne, P.A.</creatorcontrib><creatorcontrib>Seebach, J.</creatorcontrib><creatorcontrib>Ribi, C.</creatorcontrib><creatorcontrib>Villard, J.</creatorcontrib><creatorcontrib>Dietrich, P. Y.</creatorcontrib><creatorcontrib>George, A. C.</creatorcontrib><creatorcontrib>Favet, L.</creatorcontrib><creatorcontrib>Delden, C.</creatorcontrib><creatorcontrib>Morard, I.</creatorcontrib><creatorcontrib>Mentha, G.</creatorcontrib><creatorcontrib>Giostra, E.</creatorcontrib><creatorcontrib>Hadaya, K.</creatorcontrib><creatorcontrib>Martin, P. Y.</creatorcontrib><creatorcontrib>Soccal, P.</creatorcontrib><creatorcontrib>Berney, T.</creatorcontrib><creatorcontrib>Noble, S.</creatorcontrib><creatorcontrib>Mohty, B.</creatorcontrib><creatorcontrib>Nagy, M.</creatorcontrib><creatorcontrib>Chalandon, Y.</creatorcontrib><creatorcontrib>Roosnek, E.</creatorcontrib><creatorcontrib>Passweg, J.</creatorcontrib><creatorcontrib>Kaiser, L.</creatorcontrib><creatorcontrib>Yerly, S.</creatorcontrib><creatorcontrib>Thomas, Y.</creatorcontrib><creatorcontrib>Wunderli, W.</creatorcontrib><creatorcontrib>H1N1 Study Group</creatorcontrib><title>Strong serological responses and HIV RNA increase following AS03‐adjuvanted pandemic immunization in HIV‐infected patients</title><title>HIV medicine</title><addtitle>HIV Med</addtitle><description>Introduction We aimed to determine the antibody responses and effect on viral load of the AS03‐adjuvanted pandemic H1N1 vaccine in HIV‐infected patients. Method A total of 121 HIV‐infected patients and 138 healthy subjects were enrolled in a prospective, open‐label study. Healthy subjects received one dose and HIV‐infected patients two doses of the AS03‐adjuvanted split influenza A/09/H1N1 vaccine (Pandemrix®; GlaxoSmithKline, Brentford, United Kingdom.) at an interval of 3–4 weeks. The study was extended in 2010/2011 for 66 patients. Geometric mean titres (GMTs), seroprotection rates (post‐vaccination titre ≥1:40) and HIV‐1 RNA levels were measured before and 4 weeks after immunization. Results After two immunizations, the seroprotection rate (94.2 vs. 87%, respectively) and GMT (376 vs. 340, respectively) in HIV‐infected patients were as high as in healthy subjects after one dose, regardless of CD4 cell count. Four weeks after immunization, HIV RNA was detected in plasma samples from 40 of 68 (58.0%) previously aviraemic patients [median 152 HIV‐1 RNA copies/mL; interquartile range (IQR) 87–509 copies/mL]. Subsequent measures indicated that HIV RNA levels had again declined to &lt;20 copies/mL in most patients (27 of 34; 79.4%). Following (nonadjuvanted) influenza immunization in 2010/2011, HIV RNA levels only slightly increased (median final level 28 copies/mL) in three of 66 (4.5%) previously aviraemic patients, including two of 25 (8%) patients in whom an increase had been elicited by AS03‐adjuvanted vaccine the year before. Conclusion Most HIV‐infected patients developed seroprotection after two doses of AS03‐adjuvanted pandemic vaccine. A transient effect on HIV RNA levels was observed in previously aviraemic patients. A booster dose of the nonadjuvanted influenza vaccine containing the A/09/H1N1 strain the following year did not reproduce this finding, indicating a non‐antigen‐specific adjuvant effect.</description><subject>adjuvanted H1N1 vaccine</subject><subject>Adjuvants</subject><subject>Adult</subject><subject>alpha-Tocopherol - administration &amp; dosage</subject><subject>alpha-Tocopherol - immunology</subject><subject>Antibodies</subject><subject>Antibodies, Viral - blood</subject><subject>CD4 antigen</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Hemagglutination Inhibition Tests</subject><subject>HIV</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - isolation &amp; purification</subject><subject>Human immunodeficiency virus 1</subject><subject>Humans</subject><subject>Immunization</subject><subject>Influenza A</subject><subject>Influenza Vaccines - administration &amp; dosage</subject><subject>Influenza Vaccines - immunology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>pandemics</subject><subject>Polysorbates - administration &amp; dosage</subject><subject>Prospective Studies</subject><subject>RNA</subject><subject>RNA, Viral - blood</subject><subject>seroprotection</subject><subject>Squalene - administration &amp; dosage</subject><subject>Squalene - immunology</subject><subject>Vaccines</subject><subject>viraemia</subject><subject>Viral Load</subject><issn>1464-2662</issn><issn>1468-1293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkctO3TAQhi3UCijwCsg7Vkk9dmLHEpsjVC4SKlK5bC2fxEY-SuwQJ9wWiEfoM_ZJ6nCALbOZkeb7ZzEfQhhIDql-rnIoeJUBlSynBCAnRHLIHzfQ9ufi29tcZJRzuoV-xLgiBASTZBNtUUokY4Jto5fLcQj-FkczhDbculq3eDCxDz6aiLVv8OnZDf7ze4Gdrwejo8E2tG14cCm0uCTs3-tf3ayme-1H0-A-JUznauy6bvLuWY8u-BSdryTSeWvqNTc648e4i75b3Uaz99530PXxr6uj0-z84uTsaHGe9awoIasrywm1TbO0pWWitFSURSVFVVEpABpWVcWyXgrJBOfGiqKhpWZQE14WRIJkO-hgfbcfwt1k4qg6F2vTttqbMEUlJQNSSICvSV6BAMZJIvffyWnZmUb1g-v08KQ-npuAwzXw4Frz9LkHomaJaqVmV2p2pWaJ6k2ielTpV2lg_wEr8JFA</recordid><startdate>201204</startdate><enddate>201204</enddate><creator>Calmy, A</creator><creator>Bel, M</creator><creator>Nguyen, A</creator><creator>Combescure, C</creator><creator>Delhumeau, C</creator><creator>Meier, S</creator><creator>Yerly, S</creator><creator>Kaiser, L</creator><creator>Hirschel, B</creator><creator>Siegrist, C‐A</creator><creator>Siegrist, C. 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Y. ; Soccal, P. ; Berney, T. ; Noble, S. ; Mohty, B. ; Nagy, M. ; Chalandon, Y. ; Roosnek, E. ; Passweg, J. ; Kaiser, L. ; Yerly, S. ; Thomas, Y. ; Wunderli, W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p3451-c8f602fddbf5f375f27548978829711d3884bcb793766ef74d25a31c065409193</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>adjuvanted H1N1 vaccine</topic><topic>Adjuvants</topic><topic>Adult</topic><topic>alpha-Tocopherol - administration &amp; dosage</topic><topic>alpha-Tocopherol - immunology</topic><topic>Antibodies</topic><topic>Antibodies, Viral - blood</topic><topic>CD4 antigen</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Hemagglutination Inhibition Tests</topic><topic>HIV</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - isolation &amp; purification</topic><topic>Human immunodeficiency virus 1</topic><topic>Humans</topic><topic>Immunization</topic><topic>Influenza A</topic><topic>Influenza Vaccines - administration &amp; dosage</topic><topic>Influenza Vaccines - immunology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>pandemics</topic><topic>Polysorbates - administration &amp; dosage</topic><topic>Prospective Studies</topic><topic>RNA</topic><topic>RNA, Viral - blood</topic><topic>seroprotection</topic><topic>Squalene - administration &amp; dosage</topic><topic>Squalene - immunology</topic><topic>Vaccines</topic><topic>viraemia</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Calmy, A</creatorcontrib><creatorcontrib>Bel, M</creatorcontrib><creatorcontrib>Nguyen, A</creatorcontrib><creatorcontrib>Combescure, C</creatorcontrib><creatorcontrib>Delhumeau, C</creatorcontrib><creatorcontrib>Meier, S</creatorcontrib><creatorcontrib>Yerly, S</creatorcontrib><creatorcontrib>Kaiser, L</creatorcontrib><creatorcontrib>Hirschel, B</creatorcontrib><creatorcontrib>Siegrist, C‐A</creatorcontrib><creatorcontrib>Siegrist, C. 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C.</creatorcontrib><creatorcontrib>Favet, L.</creatorcontrib><creatorcontrib>Delden, C.</creatorcontrib><creatorcontrib>Morard, I.</creatorcontrib><creatorcontrib>Mentha, G.</creatorcontrib><creatorcontrib>Giostra, E.</creatorcontrib><creatorcontrib>Hadaya, K.</creatorcontrib><creatorcontrib>Martin, P. Y.</creatorcontrib><creatorcontrib>Soccal, P.</creatorcontrib><creatorcontrib>Berney, T.</creatorcontrib><creatorcontrib>Noble, S.</creatorcontrib><creatorcontrib>Mohty, B.</creatorcontrib><creatorcontrib>Nagy, M.</creatorcontrib><creatorcontrib>Chalandon, Y.</creatorcontrib><creatorcontrib>Roosnek, E.</creatorcontrib><creatorcontrib>Passweg, J.</creatorcontrib><creatorcontrib>Kaiser, L.</creatorcontrib><creatorcontrib>Yerly, S.</creatorcontrib><creatorcontrib>Thomas, Y.</creatorcontrib><creatorcontrib>Wunderli, W.</creatorcontrib><creatorcontrib>H1N1 Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>HIV medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Calmy, A</au><au>Bel, M</au><au>Nguyen, A</au><au>Combescure, C</au><au>Delhumeau, C</au><au>Meier, S</au><au>Yerly, S</au><au>Kaiser, L</au><au>Hirschel, B</au><au>Siegrist, C‐A</au><au>Siegrist, C. A.</au><au>Posfay‐Barbe, K.</au><au>Meier, S.</au><au>Bel, M.</au><au>Grillet, S.</au><au>Sealy, G.</au><au>Demeules, J.</au><au>Charvat, S.</au><au>Verdon, M.</au><au>Combescure, C.</au><au>Hirschel, B.</au><au>Calmy, A.</au><au>Nguyen, A.</au><au>Delhumeau‐Cartier, C.</au><au>Gabay, C.</au><au>Guerne, P.A.</au><au>Seebach, J.</au><au>Ribi, C.</au><au>Villard, J.</au><au>Dietrich, P. Y.</au><au>George, A. C.</au><au>Favet, L.</au><au>Delden, C.</au><au>Morard, I.</au><au>Mentha, G.</au><au>Giostra, E.</au><au>Hadaya, K.</au><au>Martin, P. Y.</au><au>Soccal, P.</au><au>Berney, T.</au><au>Noble, S.</au><au>Mohty, B.</au><au>Nagy, M.</au><au>Chalandon, Y.</au><au>Roosnek, E.</au><au>Passweg, J.</au><au>Kaiser, L.</au><au>Yerly, S.</au><au>Thomas, Y.</au><au>Wunderli, W.</au><aucorp>H1N1 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Strong serological responses and HIV RNA increase following AS03‐adjuvanted pandemic immunization in HIV‐infected patients</atitle><jtitle>HIV medicine</jtitle><addtitle>HIV Med</addtitle><date>2012-04</date><risdate>2012</risdate><volume>13</volume><issue>4</issue><spage>207</spage><epage>218</epage><pages>207-218</pages><issn>1464-2662</issn><eissn>1468-1293</eissn><abstract>Introduction We aimed to determine the antibody responses and effect on viral load of the AS03‐adjuvanted pandemic H1N1 vaccine in HIV‐infected patients. Method A total of 121 HIV‐infected patients and 138 healthy subjects were enrolled in a prospective, open‐label study. Healthy subjects received one dose and HIV‐infected patients two doses of the AS03‐adjuvanted split influenza A/09/H1N1 vaccine (Pandemrix®; GlaxoSmithKline, Brentford, United Kingdom.) at an interval of 3–4 weeks. The study was extended in 2010/2011 for 66 patients. Geometric mean titres (GMTs), seroprotection rates (post‐vaccination titre ≥1:40) and HIV‐1 RNA levels were measured before and 4 weeks after immunization. Results After two immunizations, the seroprotection rate (94.2 vs. 87%, respectively) and GMT (376 vs. 340, respectively) in HIV‐infected patients were as high as in healthy subjects after one dose, regardless of CD4 cell count. Four weeks after immunization, HIV RNA was detected in plasma samples from 40 of 68 (58.0%) previously aviraemic patients [median 152 HIV‐1 RNA copies/mL; interquartile range (IQR) 87–509 copies/mL]. Subsequent measures indicated that HIV RNA levels had again declined to &lt;20 copies/mL in most patients (27 of 34; 79.4%). Following (nonadjuvanted) influenza immunization in 2010/2011, HIV RNA levels only slightly increased (median final level 28 copies/mL) in three of 66 (4.5%) previously aviraemic patients, including two of 25 (8%) patients in whom an increase had been elicited by AS03‐adjuvanted vaccine the year before. Conclusion Most HIV‐infected patients developed seroprotection after two doses of AS03‐adjuvanted pandemic vaccine. A transient effect on HIV RNA levels was observed in previously aviraemic patients. A booster dose of the nonadjuvanted influenza vaccine containing the A/09/H1N1 strain the following year did not reproduce this finding, indicating a non‐antigen‐specific adjuvant effect.</abstract><cop>England</cop><pmid>22093373</pmid><doi>10.1111/j.1468-1293.2011.00961.x</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects adjuvanted H1N1 vaccine
Adjuvants
Adult
alpha-Tocopherol - administration & dosage
alpha-Tocopherol - immunology
Antibodies
Antibodies, Viral - blood
CD4 antigen
Drug Combinations
Female
Hemagglutination Inhibition Tests
HIV
HIV Infections - immunology
HIV Infections - virology
HIV-1 - isolation & purification
Human immunodeficiency virus 1
Humans
Immunization
Influenza A
Influenza Vaccines - administration & dosage
Influenza Vaccines - immunology
Male
Middle Aged
pandemics
Polysorbates - administration & dosage
Prospective Studies
RNA
RNA, Viral - blood
seroprotection
Squalene - administration & dosage
Squalene - immunology
Vaccines
viraemia
Viral Load
title Strong serological responses and HIV RNA increase following AS03‐adjuvanted pandemic immunization in HIV‐infected patients
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