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Vaccine. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adul

Giuseppe

Emeritus
Vaccine. 2009 Aug 12. [Epub ahead of print]

Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults.

Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Dram? M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW. - Dept. of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Hong Kong.

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 (3.75mug 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/05/2005. 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.

PMID: 19683087 [PubMed - as supplied by publisher]

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