Journal
VACCINE
Volume 27, Issue 52, Pages 7428-7435Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2009.07.102
Keywords
Influenza; Vaccine; H5N1 virus
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Funding
- GlaxoSmithKline Biologicals'
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The immunogenicity and lot-to-lot consistency of an AS03-adjuvanted H5N1 vaccine were evaluated in 1206 Asian adults, randomised to receive two doses of adjuvanted (3.75 mu g haemagglutinin) or diluent-mixed vaccines, 21 days apart. Post-Dose 2, 96.0% of vaccinees in the H5N1-AS03 group demonstrated a four-fold increase in neutralising antibody titres against the vaccine strain A/Vietnam/1194/2004 and 91.4% against strain A/Indonesia/0512005. Haemagglutination-inhibiting antibodies (titre >= 1:40) against A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains were observed in 94.3% and 50.2% of subjects, respectively. Lot-to-lot consistency of the AS03-adjuvanted vaccine combinations was demonstrated. The AS03-adjuvanted vaccine was well tolerated, induced a high frequency of immune responses to the vaccine strain, allowed antigen sparing and promoted cross-clade immunity. These characteristics make it suitable for presumptive use if an H5N1 pandemic were considered to be imminent. (C) 2009 Elsevier Ltd. All rights reserved.
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