tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2011 Mar 30. [Epub ahead of print]
Effect on cellular and humoral immune responses of the AS03 Adjuvant System in an A/H1N1/2009 influenza vaccine administered to adults during two randomised controlled trials.
Roman F, Cl?ment F, Dew? W, Walravens K, Maes C, Willekens J, De Boever F, Hanon E, Leroux-Roels G.
GlaxoSmithKline Biologicals, Wavre, Belgium; Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium; GlaxoSmithKline Biologicals, Rixensart, Belgium.
Abstract
Background: The influence of AS03A, a tocopherol oil-in-water emulsion based Adjuvant System, was investigated on humoral and cell-mediated responses to A/California/7/2009 H1N1 pandemic vaccine. Methods: In two observer-blind studies a total of 261 healthy adults aged 18-60 years were randomised to receive either AS03A-adjuvanted H1N1 vaccine containing 3.75μg haemagglutinin (HA) or non-adjuvanted H1N1 vaccine containing 15μg HA or 3.75μg HA on Days 0 and 21. Haemagglutination-inhibition (HI) antibody and T-cell responses were analyzed up to Day 42. Results: A first dose of AS03A-adjuvanted vaccine (3.75μg HA) or non-adjuvanted vaccine (15μg HA) induced HI responses of similar magnitude that exceeded licensure criteria (e.g. 94-100% with titres ≥40). A lower response following 3.75μg HA without adjuvant was observed (73% with titres ≥40). Following a second dose, geometric mean HI titres at Day 42 were higher for AS03A-adjuvanted vaccine (636 and 637) relative to non-adjuvanted vaccine (341 for 15μg HA and 150 for 3.75μg 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 compared to the non-adjuvanted group. There was no evidence of correlation between baseline CD4(+) T-cell frequencies and Day 21 HI antibody titres while there was some correlation (R=0.35) between Day 21 CD4(+) T-cell frequencies and Day 42 HI titres. Conclusions: 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.
PMID: 21450978 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21450978
Effect on cellular and humoral immune responses of the AS03 Adjuvant System in an A/H1N1/2009 influenza vaccine administered to adults during two randomised controlled trials.
Roman F, Cl?ment F, Dew? W, Walravens K, Maes C, Willekens J, De Boever F, Hanon E, Leroux-Roels G.
GlaxoSmithKline Biologicals, Wavre, Belgium; Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium; GlaxoSmithKline Biologicals, Rixensart, Belgium.
Abstract
Background: The influence of AS03A, a tocopherol oil-in-water emulsion based Adjuvant System, was investigated on humoral and cell-mediated responses to A/California/7/2009 H1N1 pandemic vaccine. Methods: In two observer-blind studies a total of 261 healthy adults aged 18-60 years were randomised to receive either AS03A-adjuvanted H1N1 vaccine containing 3.75μg haemagglutinin (HA) or non-adjuvanted H1N1 vaccine containing 15μg HA or 3.75μg HA on Days 0 and 21. Haemagglutination-inhibition (HI) antibody and T-cell responses were analyzed up to Day 42. Results: A first dose of AS03A-adjuvanted vaccine (3.75μg HA) or non-adjuvanted vaccine (15μg HA) induced HI responses of similar magnitude that exceeded licensure criteria (e.g. 94-100% with titres ≥40). A lower response following 3.75μg HA without adjuvant was observed (73% with titres ≥40). Following a second dose, geometric mean HI titres at Day 42 were higher for AS03A-adjuvanted vaccine (636 and 637) relative to non-adjuvanted vaccine (341 for 15μg HA and 150 for 3.75μg 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 compared to the non-adjuvanted group. There was no evidence of correlation between baseline CD4(+) T-cell frequencies and Day 21 HI antibody titres while there was some correlation (R=0.35) between Day 21 CD4(+) T-cell frequencies and Day 42 HI titres. Conclusions: 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.
PMID: 21450978 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21450978