Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults
Journal
Vaccine
Journal Volume
27
Journal Issue
52
Pages
7428
Date Issued
2009-12-09
Author(s)
Chu, Daniel Wai-Sing
Hwang, Shinn-Jang
Lim, Fong Seng
Oh, Helen May Lin
Thongcharoen, Prasert
Bock, Hans L
Dramé, Mamadou
Gillard, Paul
Hutagalung, Yanee
Tang, Haiwen
Teoh, Yee Leong
Ballou, Ripley W
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.
Subjects
Influenza; Vaccine; H5N1 virus; CROSS-REACTIVE IMMUNITY; PANDEMIC INFLUENZA; H5N1; EVOLUTION; SAFETY; TRIAL
SDGs
Publisher
ELSEVIER SCI LTD
Type
journal article