title: Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults.
abstract: 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 microg 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 > or = 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.
authors.affiliation: Dept. of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Hong Kong. chuwsd@ha.org.hk
authors.forename: Daniel Wai-Sing
authors.initials: DW
authors.lastname: Chu
authors.forename: Shinn-Jang
authors.initials: SJ
authors.lastname: Hwang
authors.forename: Fong Seng
authors.initials: FS
authors.lastname: Lim
authors.forename: Helen May Lin
authors.initials: HM
authors.lastname: Oh
authors.forename: Prasert
authors.initials: P
authors.lastname: Thongcharoen
authors.forename: Pan-Chyr
authors.initials: PC
authors.lastname: Yang
authors.forename: Hans L
authors.initials: HL
authors.lastname: Bock
authors.forename: Mamadou
authors.initials: M
authors.lastname: Dramé
authors.forename: Paul
authors.initials: P
authors.lastname: Gillard
authors.forename: Yanee
authors.initials: Y
authors.lastname: Hutagalung
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.forename: Yee Leong
authors.initials: YL
authors.lastname: Teoh
authors.forename: Ripley W
authors.initials: RW
authors.lastname: Ballou
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology*; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D003429:Cross Reactions / Q000276:immunology; D005260:Female; D006386:Hemagglutination Tests; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines