Source: Annual Congress 2010 - Influenza A (H1N1) and other viral infections: therapeutic aspects
Disease area: Airway diseases, Respiratory infections

Abstract

Recombinant influenza hemagglutinin (rHA) vaccine approaches overcome inefficiencies of egg-based vaccines and when combined with novel adjuvants offer major benefits for future pandemic vaccine supply. The recent H1N1 2009 pandemic provided an ideal opportunity to test the benefits of cutting-edge vaccine technologies in a real-life setting. A randomised trial of a novel rHA pandemic influenza vaccine (Panblok H1/2009) with a polysaccharide adjuvant (Advax) commenced in July 2009 in Adelaide, Australia in 281 adults aged 18-70 years. Subjects received rHA (3, 11 or 45 g) with or without Advax . Endpoints were safety (adverse events), seroprotection, seroconversion and geometric mean titer (GMT) increase measured by hemagglutination inhibition (HAI) assay. Seroprotection and seroconversion rates after a single immunization with rHA were comparable to those reported for traditional inactivated H1N1 2009 vaccines. Higher serological responses were seen in young vs older subjects, in those receiving high vs low antigen doses, and in those receiving adjuvant vs unadjuvanted vaccine. Highest responses were in the 18-49 year old group receiving 45 ug of adjuvanted vaccine with a response comparable to HAI titers of patients recovering from actual H1N1 2009 infection. Inclusion of Advax adjuvant significantly improved both seroprotection (OR=1.7) and seroconversion (OR=1.8). Overall, the H1N1 vaccine was well tolerated with the most common adverse effect being mild injection site discomfort. Therefore, a single immunisation with a novel recombinant vaccine including Advax adjuvant induces dose-dependent seroprotection and seroconversion against pandemic influenza.

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D. Sajkov, D. Gordon, Y. Honda-Okubo, M. Cox, R. Woodman, N. Petrovsky (Adelaide, Australia; Meriden, United States Of America). Immunogenicity and safety of a novel recombinant pandemic influenza vaccine containing a polysaccharide adjuvant. Eur Respir J 2010; 36: Suppl. 54, 2975

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