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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.

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 ?g hemagglutinin (HA) or nonadjuvanted H1N1 vaccine containing 15 or 3.75 ?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 ?g HA) or nonadjuvanted vaccine (15 ?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 ?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 AS03(A)-adjuvanted vaccine (636 and 637) relative to nonadjuvanted vaccine (341 for 15 ?g HA and 150 for 3.75 ?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. AS03(A) 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.

SUBMITTER: Roman F

PROVIDER: S-EPMC3122530 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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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.

Roman François F Clément Frédéric F Dewé Walthère W Walravens Karl K Maes Cathy C Willekens Julie J De Boever Fien F Hanon Emmanuel E Leroux-Roels Geert G

Clinical and vaccine immunology : CVI 20110330 5

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 μg hemagglutinin (HA) or nonadjuvanted H1N1 vaccine containing 15 or 3.75 μg HA on days 0 and 21. Hemagglutination inhibition (HI) antibody and T-cell ...[more]

PMID: 21450978

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Project description:ObjectivesTo assess the safety of an AS03-adjuvanted split virion H1N1 (2009) vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza vaccination campaign in the UK.DesignProspective, cohort, observational, postauthorisation safety study.Setting87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England.ParticipantsA cohort of 9143 individuals aged 7 months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 pandemic vaccine during the national pandemic influenza vaccination campaign in the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were previous vaccination with other H1N1 pandemic vaccine and any child in care.Primary and secondary outcome measuresMedically attended adverse events (MAEs) occurring within 31 days after any dose, serious adverse events (SAEs) and adverse events of special interest (AESIs) following vaccination were collected for all participants. Solicited adverse events (AEs) were assessed in a subset of participants.ResultsMAEs were reported in 1219 participants and SAEs in 113 participants during the 31-day postvaccination period. The most frequently reported MAEs and SAEs were consistent with events expected to be reported during the winter season in this population: lower respiratory tract infections, asthma and pneumonia. The most commonly reported solicited AEs were irritability in young children aged <5 years (61.8%), muscle aches in children aged 5-17 years (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the criteria to be considered for the observed-to-expected analyses. AESIs above the expected number were neuritis (1 case within 31 days) and convulsions (8 cases within 181 days). There were 41 deaths during the 181-day period after vaccination, fewer than expected.ConclusionsResults indicate that the AS03-adjuvanted H1N1 pandemic vaccine showed a clinically acceptable reactogenicity and safety profile in all age and risk groups studied.Trial registrationClinicalTrials.gov, NCT00996853.

Dataset Information

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.

Publications

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.

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