Increased immunogenicity of the MF59-adjuvanted influenza vaccine compared to a conventional subunit vaccine in elderly subjects

Eur J Epidemiol. 2001;17(2):135-40. doi: 10.1023/a:1017919305501.

Abstract

Three-hundred and eight outpatient elderly subjects (> or = 65 years) were randomly assigned to receive the MF59-adjuvanted influenza vaccine (FLU-AD; n = 204) or a conventional subunit influenza vaccine (AGRIPPAL S1; n = 104) in order to compare the safety and immunogenicity of the two vaccines. Although mild pain at the injection site was reported more frequently by subjects immunised with the adjuvanted vaccine, both vaccines were shown to be safe and well tolerated. The adjuvanted vaccine was more immunogenic as indicated by higher post-immunisation geometric mean titres (GMTs) and by higher proportions of subjects with post-immunisation > or = four fold increases of antibody titres or subjects with > or = 1/160 post-immunisation HI titres. These differences, statistically significant for all three strains after immunisation, indicated that, by addition of the MF59 adjuvant emulsion, conventional subunit influenza antigens acquire an enhanced immunogenicity without any clinically significant increase of their reactogenicity.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Aged
  • Antibodies, Viral / blood
  • Antibodies, Viral / drug effects
  • Antibodies, Viral / immunology
  • Antigens, Viral / blood
  • Antigens, Viral / drug effects
  • Antigens, Viral / immunology
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Hemagglutination Inhibition Tests
  • Humans
  • Influenza A virus / drug effects
  • Influenza A virus / immunology
  • Influenza B virus / drug effects
  • Influenza B virus / immunology
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / immunology*
  • Influenza Vaccines / therapeutic use*
  • Italy / epidemiology
  • Male
  • Polysorbates / therapeutic use*
  • Prospective Studies
  • Squalene / therapeutic use*
  • Time Factors
  • Vaccines, Subunit / adverse effects
  • Vaccines, Subunit / immunology
  • Vaccines, Subunit / therapeutic use

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Antigens, Viral
  • Influenza Vaccines
  • MF59 oil emulsion
  • Polysorbates
  • Vaccines, Subunit
  • Squalene