Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults
Background Long-term persistence of immune response and safety of two doses of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (an α-tocopherol oil-in-water emulsion-based Adjuvant System) administered 21 d apart was evaluated in Japanese adults [NCT00989612]. Methods On...
Gespeichert in:
| Veröffentlicht in: | Human vaccines & immunotherapeutics 2012-02, Vol.8 (2), p.260-266 |
|---|---|
| Hauptverfasser: | , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 266 |
|---|---|
| container_issue | 2 |
| container_start_page | 260 |
| container_title | Human vaccines & immunotherapeutics |
| container_volume | 8 |
| creator | Ikematsu, Hideyuki Nagai, Hideaki Kawashima, Masahiro Kawakami, Yasunobu Tenjinbaru, Kazuyoshi Li, Ping Walravens, Karl Gillard, Paul Roman, François |
| description | Background
Long-term persistence of immune response and safety of two doses of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (an α-tocopherol oil-in-water emulsion-based Adjuvant System) administered 21 d apart was evaluated in Japanese adults [NCT00989612].
Methods
One-hundred healthy subjects aged 20−64 y (stratified [1:1] into two age strata 20−40 y and 41−64 y) received 21 d apart, two doses of AS03-adjuvanted 3.75µg haemagglutinin (HA) H1N1 2009 vaccine. Immunogenicity data by haemagglutination inhibition (HI) assay six months after the first vaccine dose (Day 182) and microneutralization assay following each of the two vaccine doses (Days 21 and 42) and at Day 182 are reported here.
Results
Persistence of strong HI immune response was observed at Day 182 that met the US and European regulatory thresholds for pandemic influenza vaccines (seroprotection rate: 95%; seroconversion rate: 93%; geometric mean fold-rise: 20). The neutralizing antibody response against the A/Netherlands/602/2009 strain (antigenically similar to vaccine-strain) persisted for at least up to Day 182 (vaccine response rate: 76%; geometric mean titer: 114.4) and paralleled the HI immune response at all time points. No marked difference was observed in HI antibody persistence and neutralising antibody response between the two age strata. The vaccine had a clinically-acceptable safety profile.
Conclusion
Two priming doses of H1N1 2009 pandemic influenza vaccine induced an immune response persisting for at least six months after the first vaccine dose. This could be beneficial in evaluating the importance and effect of vaccination with this AS03-adjuvanted pandemic influenza vaccine. |
| doi_str_mv | 10.4161/hv.18469 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_crossref_primary_10_4161_hv_18469</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1014114062</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3489-578e020904285b7d031bcb300a6da06992a31fb29b3cf29525fc040988d192693</originalsourceid><addsrcrecordid>eNqFkc1u1DAUhSMEolWpxBMgL9mk9U_iJBuk0QgYUFUk_sTOurGdiSvHDrYzo-mj8LRkOsMAYoE3tq6_c66vT5Y9J_iqIJxc95srUhe8eZSdU8KLvCyLb49PZ1KeZZcx3uF5VZgWnD_NzigtKGe8Oc9-LHsIIJMO5h6S8Q6BU8h6t87n2oBGHaKJSTupke-QGYbJaRR0HL2LGnXeWr81bo3S1iPlo457DBxafMJskYO6mzbgklZoRW4JMq6zk3b3gDYgpZmtjEO9Bpv6HXoPIzg9u4KabIrPsicd2Kgvj_tF9uXN68_LVX7z4e275eIml6yom7ysao0pbnBB67KtFGaklS3DGLgCzJuGAiNdS5uWyY42JS07iQvc1LUiDeUNu8heHXzHqR20ktqlAFaMwQwQdsKDEX_fONOLtd8IxnhV4b3By6NB8N8nHZMYTJTa2nkaP0VBMCkIKTCnv1EZfIxBd6c2BIt9mqLfiIc0Z_TFn886gb-ymwF-AOY-SsfW-CjNPqgTevzjKCAkI60-OV__R0gxIauvmFTkoxhVNyvYQTHn58MAWx-sEgl21ocugJMmCvbPBD8BomLS3Q</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1014114062</pqid></control><display><type>article</type><title>Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults</title><source>MEDLINE</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Ikematsu, Hideyuki ; Nagai, Hideaki ; Kawashima, Masahiro ; Kawakami, Yasunobu ; Tenjinbaru, Kazuyoshi ; Li, Ping ; Walravens, Karl ; Gillard, Paul ; Roman, François</creator><creatorcontrib>Ikematsu, Hideyuki ; Nagai, Hideaki ; Kawashima, Masahiro ; Kawakami, Yasunobu ; Tenjinbaru, Kazuyoshi ; Li, Ping ; Walravens, Karl ; Gillard, Paul ; Roman, François</creatorcontrib><description>Background
Long-term persistence of immune response and safety of two doses of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (an α-tocopherol oil-in-water emulsion-based Adjuvant System) administered 21 d apart was evaluated in Japanese adults [NCT00989612].
Methods
One-hundred healthy subjects aged 20−64 y (stratified [1:1] into two age strata 20−40 y and 41−64 y) received 21 d apart, two doses of AS03-adjuvanted 3.75µg haemagglutinin (HA) H1N1 2009 vaccine. Immunogenicity data by haemagglutination inhibition (HI) assay six months after the first vaccine dose (Day 182) and microneutralization assay following each of the two vaccine doses (Days 21 and 42) and at Day 182 are reported here.
Results
Persistence of strong HI immune response was observed at Day 182 that met the US and European regulatory thresholds for pandemic influenza vaccines (seroprotection rate: 95%; seroconversion rate: 93%; geometric mean fold-rise: 20). The neutralizing antibody response against the A/Netherlands/602/2009 strain (antigenically similar to vaccine-strain) persisted for at least up to Day 182 (vaccine response rate: 76%; geometric mean titer: 114.4) and paralleled the HI immune response at all time points. No marked difference was observed in HI antibody persistence and neutralising antibody response between the two age strata. The vaccine had a clinically-acceptable safety profile.
Conclusion
Two priming doses of H1N1 2009 pandemic influenza vaccine induced an immune response persisting for at least six months after the first vaccine dose. This could be beneficial in evaluating the importance and effect of vaccination with this AS03-adjuvanted pandemic influenza vaccine.</description><identifier>ISSN: 2164-5515</identifier><identifier>EISSN: 2164-554X</identifier><identifier>DOI: 10.4161/hv.18469</identifier><identifier>PMID: 22426369</identifier><language>eng</language><publisher>United States: Taylor & Francis</publisher><subject>adjuvant ; Adjuvants, Immunologic ; Adult ; Antibodies, Neutralizing - blood ; Antibodies, Neutralizing - immunology ; Antibodies, Viral - blood ; Antibodies, Viral - immunology ; AS03 ; Binding ; Biology ; Bioscience ; Calcium ; Cancer ; Cell ; Cycle ; Female ; H1N1 ; Hemagglutination Inhibition Tests ; Hemagglutinin Glycoproteins, Influenza Virus - immunology ; Humans ; Influenza A Virus, H1N1 Subtype - immunology ; Influenza Vaccines - administration & dosage ; Influenza Vaccines - immunology ; Influenza, Human - immunology ; Influenza, Human - prevention & control ; Japan ; Landes ; long-term ; Male ; Middle Aged ; Organogenesis ; pandemic ; persistence ; Proteins ; Research Paper ; Time Factors ; Vaccination ; Young Adult</subject><ispartof>Human vaccines & immunotherapeutics, 2012-02, Vol.8 (2), p.260-266</ispartof><rights>Copyright © 2012 Landes Bioscience 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3489-578e020904285b7d031bcb300a6da06992a31fb29b3cf29525fc040988d192693</citedby><cites>FETCH-LOGICAL-c3489-578e020904285b7d031bcb300a6da06992a31fb29b3cf29525fc040988d192693</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3367709/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3367709/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22426369$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ikematsu, Hideyuki</creatorcontrib><creatorcontrib>Nagai, Hideaki</creatorcontrib><creatorcontrib>Kawashima, Masahiro</creatorcontrib><creatorcontrib>Kawakami, Yasunobu</creatorcontrib><creatorcontrib>Tenjinbaru, Kazuyoshi</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Walravens, Karl</creatorcontrib><creatorcontrib>Gillard, Paul</creatorcontrib><creatorcontrib>Roman, François</creatorcontrib><title>Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults</title><title>Human vaccines & immunotherapeutics</title><addtitle>Hum Vaccin Immunother</addtitle><description>Background
Long-term persistence of immune response and safety of two doses of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (an α-tocopherol oil-in-water emulsion-based Adjuvant System) administered 21 d apart was evaluated in Japanese adults [NCT00989612].
Methods
One-hundred healthy subjects aged 20−64 y (stratified [1:1] into two age strata 20−40 y and 41−64 y) received 21 d apart, two doses of AS03-adjuvanted 3.75µg haemagglutinin (HA) H1N1 2009 vaccine. Immunogenicity data by haemagglutination inhibition (HI) assay six months after the first vaccine dose (Day 182) and microneutralization assay following each of the two vaccine doses (Days 21 and 42) and at Day 182 are reported here.
Results
Persistence of strong HI immune response was observed at Day 182 that met the US and European regulatory thresholds for pandemic influenza vaccines (seroprotection rate: 95%; seroconversion rate: 93%; geometric mean fold-rise: 20). The neutralizing antibody response against the A/Netherlands/602/2009 strain (antigenically similar to vaccine-strain) persisted for at least up to Day 182 (vaccine response rate: 76%; geometric mean titer: 114.4) and paralleled the HI immune response at all time points. No marked difference was observed in HI antibody persistence and neutralising antibody response between the two age strata. The vaccine had a clinically-acceptable safety profile.
Conclusion
Two priming doses of H1N1 2009 pandemic influenza vaccine induced an immune response persisting for at least six months after the first vaccine dose. This could be beneficial in evaluating the importance and effect of vaccination with this AS03-adjuvanted pandemic influenza vaccine.</description><subject>adjuvant</subject><subject>Adjuvants, Immunologic</subject><subject>Adult</subject><subject>Antibodies, Neutralizing - blood</subject><subject>Antibodies, Neutralizing - immunology</subject><subject>Antibodies, Viral - blood</subject><subject>Antibodies, Viral - immunology</subject><subject>AS03</subject><subject>Binding</subject><subject>Biology</subject><subject>Bioscience</subject><subject>Calcium</subject><subject>Cancer</subject><subject>Cell</subject><subject>Cycle</subject><subject>Female</subject><subject>H1N1</subject><subject>Hemagglutination Inhibition Tests</subject><subject>Hemagglutinin Glycoproteins, Influenza Virus - immunology</subject><subject>Humans</subject><subject>Influenza A Virus, H1N1 Subtype - immunology</subject><subject>Influenza Vaccines - administration & dosage</subject><subject>Influenza Vaccines - immunology</subject><subject>Influenza, Human - immunology</subject><subject>Influenza, Human - prevention & control</subject><subject>Japan</subject><subject>Landes</subject><subject>long-term</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Organogenesis</subject><subject>pandemic</subject><subject>persistence</subject><subject>Proteins</subject><subject>Research Paper</subject><subject>Time Factors</subject><subject>Vaccination</subject><subject>Young Adult</subject><issn>2164-5515</issn><issn>2164-554X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>0YH</sourceid><sourceid>EIF</sourceid><recordid>eNqFkc1u1DAUhSMEolWpxBMgL9mk9U_iJBuk0QgYUFUk_sTOurGdiSvHDrYzo-mj8LRkOsMAYoE3tq6_c66vT5Y9J_iqIJxc95srUhe8eZSdU8KLvCyLb49PZ1KeZZcx3uF5VZgWnD_NzigtKGe8Oc9-LHsIIJMO5h6S8Q6BU8h6t87n2oBGHaKJSTupke-QGYbJaRR0HL2LGnXeWr81bo3S1iPlo457DBxafMJskYO6mzbgklZoRW4JMq6zk3b3gDYgpZmtjEO9Bpv6HXoPIzg9u4KabIrPsicd2Kgvj_tF9uXN68_LVX7z4e275eIml6yom7ysao0pbnBB67KtFGaklS3DGLgCzJuGAiNdS5uWyY42JS07iQvc1LUiDeUNu8heHXzHqR20ktqlAFaMwQwQdsKDEX_fONOLtd8IxnhV4b3By6NB8N8nHZMYTJTa2nkaP0VBMCkIKTCnv1EZfIxBd6c2BIt9mqLfiIc0Z_TFn886gb-ymwF-AOY-SsfW-CjNPqgTevzjKCAkI60-OV__R0gxIauvmFTkoxhVNyvYQTHn58MAWx-sEgl21ocugJMmCvbPBD8BomLS3Q</recordid><startdate>20120201</startdate><enddate>20120201</enddate><creator>Ikematsu, Hideyuki</creator><creator>Nagai, Hideaki</creator><creator>Kawashima, Masahiro</creator><creator>Kawakami, Yasunobu</creator><creator>Tenjinbaru, Kazuyoshi</creator><creator>Li, Ping</creator><creator>Walravens, Karl</creator><creator>Gillard, Paul</creator><creator>Roman, François</creator><general>Taylor & Francis</general><general>Landes Bioscience</general><scope>0YH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20120201</creationdate><title>Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults</title><author>Ikematsu, Hideyuki ; Nagai, Hideaki ; Kawashima, Masahiro ; Kawakami, Yasunobu ; Tenjinbaru, Kazuyoshi ; Li, Ping ; Walravens, Karl ; Gillard, Paul ; Roman, François</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3489-578e020904285b7d031bcb300a6da06992a31fb29b3cf29525fc040988d192693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>adjuvant</topic><topic>Adjuvants, Immunologic</topic><topic>Adult</topic><topic>Antibodies, Neutralizing - blood</topic><topic>Antibodies, Neutralizing - immunology</topic><topic>Antibodies, Viral - blood</topic><topic>Antibodies, Viral - immunology</topic><topic>AS03</topic><topic>Binding</topic><topic>Biology</topic><topic>Bioscience</topic><topic>Calcium</topic><topic>Cancer</topic><topic>Cell</topic><topic>Cycle</topic><topic>Female</topic><topic>H1N1</topic><topic>Hemagglutination Inhibition Tests</topic><topic>Hemagglutinin Glycoproteins, Influenza Virus - immunology</topic><topic>Humans</topic><topic>Influenza A Virus, H1N1 Subtype - immunology</topic><topic>Influenza Vaccines - administration & dosage</topic><topic>Influenza Vaccines - immunology</topic><topic>Influenza, Human - immunology</topic><topic>Influenza, Human - prevention & control</topic><topic>Japan</topic><topic>Landes</topic><topic>long-term</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Organogenesis</topic><topic>pandemic</topic><topic>persistence</topic><topic>Proteins</topic><topic>Research Paper</topic><topic>Time Factors</topic><topic>Vaccination</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ikematsu, Hideyuki</creatorcontrib><creatorcontrib>Nagai, Hideaki</creatorcontrib><creatorcontrib>Kawashima, Masahiro</creatorcontrib><creatorcontrib>Kawakami, Yasunobu</creatorcontrib><creatorcontrib>Tenjinbaru, Kazuyoshi</creatorcontrib><creatorcontrib>Li, Ping</creatorcontrib><creatorcontrib>Walravens, Karl</creatorcontrib><creatorcontrib>Gillard, Paul</creatorcontrib><creatorcontrib>Roman, François</creatorcontrib><collection>Taylor & Francis Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Human vaccines & immunotherapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ikematsu, Hideyuki</au><au>Nagai, Hideaki</au><au>Kawashima, Masahiro</au><au>Kawakami, Yasunobu</au><au>Tenjinbaru, Kazuyoshi</au><au>Li, Ping</au><au>Walravens, Karl</au><au>Gillard, Paul</au><au>Roman, François</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults</atitle><jtitle>Human vaccines & immunotherapeutics</jtitle><addtitle>Hum Vaccin Immunother</addtitle><date>2012-02-01</date><risdate>2012</risdate><volume>8</volume><issue>2</issue><spage>260</spage><epage>266</epage><pages>260-266</pages><issn>2164-5515</issn><eissn>2164-554X</eissn><abstract>Background
Long-term persistence of immune response and safety of two doses of an A/California/07/2009 H1N1 pandemic influenza vaccine adjuvanted with AS03 (an α-tocopherol oil-in-water emulsion-based Adjuvant System) administered 21 d apart was evaluated in Japanese adults [NCT00989612].
Methods
One-hundred healthy subjects aged 20−64 y (stratified [1:1] into two age strata 20−40 y and 41−64 y) received 21 d apart, two doses of AS03-adjuvanted 3.75µg haemagglutinin (HA) H1N1 2009 vaccine. Immunogenicity data by haemagglutination inhibition (HI) assay six months after the first vaccine dose (Day 182) and microneutralization assay following each of the two vaccine doses (Days 21 and 42) and at Day 182 are reported here.
Results
Persistence of strong HI immune response was observed at Day 182 that met the US and European regulatory thresholds for pandemic influenza vaccines (seroprotection rate: 95%; seroconversion rate: 93%; geometric mean fold-rise: 20). The neutralizing antibody response against the A/Netherlands/602/2009 strain (antigenically similar to vaccine-strain) persisted for at least up to Day 182 (vaccine response rate: 76%; geometric mean titer: 114.4) and paralleled the HI immune response at all time points. No marked difference was observed in HI antibody persistence and neutralising antibody response between the two age strata. The vaccine had a clinically-acceptable safety profile.
Conclusion
Two priming doses of H1N1 2009 pandemic influenza vaccine induced an immune response persisting for at least six months after the first vaccine dose. This could be beneficial in evaluating the importance and effect of vaccination with this AS03-adjuvanted pandemic influenza vaccine.</abstract><cop>United States</cop><pub>Taylor & Francis</pub><pmid>22426369</pmid><doi>10.4161/hv.18469</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2164-5515 |
| ispartof | Human vaccines & immunotherapeutics, 2012-02, Vol.8 (2), p.260-266 |
| issn | 2164-5515 2164-554X |
| language | eng |
| recordid | cdi_crossref_primary_10_4161_hv_18469 |
| source | MEDLINE; PubMed Central; Alma/SFX Local Collection |
| subjects | adjuvant Adjuvants, Immunologic Adult Antibodies, Neutralizing - blood Antibodies, Neutralizing - immunology Antibodies, Viral - blood Antibodies, Viral - immunology AS03 Binding Biology Bioscience Calcium Cancer Cell Cycle Female H1N1 Hemagglutination Inhibition Tests Hemagglutinin Glycoproteins, Influenza Virus - immunology Humans Influenza A Virus, H1N1 Subtype - immunology Influenza Vaccines - administration & dosage Influenza Vaccines - immunology Influenza, Human - immunology Influenza, Human - prevention & control Japan Landes long-term Male Middle Aged Organogenesis pandemic persistence Proteins Research Paper Time Factors Vaccination Young Adult |
| title | Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-03T06%3A28%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Characterization%20and%20long-term%20persistence%20of%20immune%20response%20following%20two%20doses%20of%20an%20AS03A-adjuvanted%20H1N1%20influenza%20vaccine%20in%20healthy%20Japanese%20adults&rft.jtitle=Human%20vaccines%20&%20immunotherapeutics&rft.au=Ikematsu,%20Hideyuki&rft.date=2012-02-01&rft.volume=8&rft.issue=2&rft.spage=260&rft.epage=266&rft.pages=260-266&rft.issn=2164-5515&rft.eissn=2164-554X&rft_id=info:doi/10.4161/hv.18469&rft_dat=%3Cproquest_cross%3E1014114062%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1014114062&rft_id=info:pmid/22426369&rfr_iscdi=true |