Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age

T-Cell Responses in Children to Internal Influenza Antigens, 1 Year After Immunization With Pandemic H1N1 Influenza Vaccine, and Response to Revaccination With Seasonal Trivalent–inactivated Influenza Vaccine

“…While the differences between the immunogenicity of the 2 pandemic vaccines may be partly attributed to vaccine type (ie, split virion versus whole virus), it is likely that the enhanced immunogenicity of the adjuvanted vaccine is largely due to the presence of the adjuvant: AS03 B . The AS03 B -adjuvanted pandemic influenza vaccine has previously been shown to be associated with increased humoral responses in children, 7,10 and it is probable that the stronger T-cell response in recipients of the AS03 B -pandemic vaccine reflects a generalized adjuvant-mediated augmentation of the adaptive immune response. Indeed, several oil-in-water adjuvants, including AS03 B and MF59, have been shown to significantly enhance immunogenicity, in healthy adults and children, to inactivated influenza A/H5N1; both AS03 B and MF59 were approved for clinical use to enhance immunogenicity of the recent pandemic H1N1 vaccines.…”

“…5 A number of studies compared adjuvanted and nonadjuvanted pandemic vaccines to optimize healthcare strategies. [6][7][8][9] A randomized, multicenter UK-based clinical trial was conducted in 2009 to assess the safety and immunogenicity of a nonadjuvanted whole virion H1N1 influenza vaccine (Celvapan; Baxter Vaccines, Vienna, Austria) compared with an AS03 B -adjuvanted split virion pandemic vaccine (Pandemrix; GlaxoSmithKline Vaccines, Rixensart, Belgium). The adjuvanted vaccine, while more reactogenic, was more immunogenic and, importantly, achieved high seroconversion rates in children younger than 3 years of age.…”

Soroproteção reduzida após a vacinação sem adjuvante contra influenza pandêmica A/H1N1 em pacientes com artrite reumatoide

“…37 The unexpectedly low immune responses in RA patients contrast with previous studies, including two with randomised designs reporting normal immunogenicity to the seasonal vaccine in RA patients. 38 39 The use of non-adjuvanted vaccine in the present study may partly explain this discrepancy, as the use of adjuvants may be required in RA to achieve maximum immunogenicity. 39 Alternatively 37 38 42 43 and AS.…”

“…38 39 The use of non-adjuvanted vaccine in the present study may partly explain this discrepancy, as the use of adjuvants may be required in RA to achieve maximum immunogenicity. 39 Alternatively 37 38 42 43 and AS. 43 The small number of patients using rituximab in our group of patients (0.8%) cannot explain the defi cient immune responses observed in some rheumatologic disease patients.…”

“…This therapy promotes the impairment of antigen processing and has implications for the efficacy of anti-viral vaccines [38,39], including the reduced vaccine response observed in SLE [14,16,17]. Regarding seasonal influenza vaccination, five studies have demonstrated impaired response [12,13,16,19,40], mainly associated with PRED doses >20 mg/day [12,16].…”