DOI: 10.1093/infdis/jiad589 ISSN: 0022-1899

A Multi-Season Randomised Controlled Trial of Advax-Adjuvanted Seasonal Influenza Vaccine in Participants with Chronic Disease or Older Age

Dimitar Sajkov, Richard Woodman, Yoshikazu Honda-Okubo, Jeffrey Barbara, Derek Chew, Barbara Toson, Nikolai Petrovsky
  • Infectious Diseases
  • Immunology and Allergy



The aim of this study was to determine the safety and immunogenicity of trivalent inactivated influenza vaccine (TIV) alone or formulated with Advax™ delta inulin adjuvant in those of older age (> 60 years) or with chronic disease.


Over four consecutive years from 2008-2011, adult participants with chronic disease or over 60 years were recruited into a randomised controlled study to assess the safety, tolerability and immunogenicity of Advax-adjuvanted versus standard TIV. The per protocol (PP) population with at least one post-baseline measurement of influenza antibodies comprised 1297 participants: 447 in the TIV, and 850 in the Advax-adjuvanted TIV, groups.


No safety issues were identified. Variables negatively affecting vaccine responses included obesity and diabetes mellitus. Advax adjuvant had a positive impact on anti-influenza IgM responses and on H3N2 and B strain seropositivity as assessed by hemagglutination inhibition.


Advax-adjuvanted TIV was safe and well tolerated in individuals with chronic disease. There is an ongoing need for research into improved influenza vaccines for high-risk populations. Australia New Zealand Clinical Trial Registry: ACTRN 12608000364370.

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