Immunogenicity and safety of Advax TM, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface anitgen: a randomized controlled Phase 1 study: A randomized controlled Phase 1 study

David Gordon, Peter Kelley, Susanne Heinzel, Peter Cooper, Nikolai Petrovsky

    Research output: Contribution to journalArticle

    49 Citations (Scopus)

    Abstract

    There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5. mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9-139.1) and 10. mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0-266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3-12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5. mg (4/6, 67%) and Advax 10. mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.

    Original languageEnglish
    Pages (from-to)6469-6477
    Number of pages9
    JournalVaccine
    Volume32
    Issue number48
    DOIs
    Publication statusPublished - 2014

    Fingerprint Dive into the research topics of 'Immunogenicity and safety of Advax TM, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface anitgen: a randomized controlled Phase 1 study: A randomized controlled Phase 1 study'. Together they form a unique fingerprint.

  • Cite this