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- aggregation classification "A1".
- aggregation creator B434554.
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- aggregation date "2011".
- aggregation format "application/pdf".
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- aggregation isPartOf urn:issn:1556-6811.
- aggregation language "eng".
- aggregation rights "I have retained and own the full copyright for this publication".
- aggregation subject "Medicine and Health Sciences".
- aggregation title "Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus Vaccine administered to adults during two randomized controlled trials".
- aggregation abstract "The influence of AS03(A), a tocopherol oil-in-water emulsion-based adjuvant system, on humoral and cell-mediated responses to A/California/7/2009 H1N1 pandemic vaccine was investigated. In two observer-blind studies, a total of 261 healthy adults aged 18 to 60 years were randomized to receive either AS03(A)-adjuvanted H1N1 vaccine containing 3.75 mu g hemagglutinin (HA) or nonadjuvanted H1N1 vaccine containing 15 or 3.75 mu g HA on days 0 and 21. Hemagglutination inhibition (HI) antibody and T-cell responses were analyzed up to day 42. A first dose of AS03(A)-adjuvanted vaccine (3.75 mu g HA) or nonadjuvanted vaccine (15 mu g HA) induced HI responses of similar magnitudes that exceeded licensure criteria (e. g., 94 to 100% with titers of >= 40). A lower response following 3.75 mu g HA without adjuvant was observed (73% with titers of >= 40). Following a second dose, geometric mean HI titers at day 42 were higher for AS03A-adjuvanted vaccine (636 and 637) relative to nonadjuvanted vaccine (341 for 15 mu g HA and 150 for 3.75 mu g HA). Over the 42-day period, the increase in frequency of A/H1N1/2009-specific CD4(+) T cells was significantly higher in the adjuvanted group than in the nonadjuvanted group. There was no evidence of correlation between baseline CD4(+) T-cell frequencies and day 21 HI antibody titers, while there was some correlation (R = 0.35) between day 21 CD4(+) T-cell frequencies and day 42 HI titers. AS03A adjuvant enhanced the humoral and CD4(+) T-cell-mediated responses to A/H1N1/2009 vaccine. Baseline A/H1N1/2009-specific CD4(+) T-cell frequencies did not predict post-dose 1 antibody responses, but there was some correlation between post-dose 1 CD4(+) T-cell frequencies and post-dose 2 antibody responses.".
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- aggregation endPage "843".
- aggregation issue "5".
- aggregation startPage "835".
- aggregation volume "18".
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