Cross-Clade Immunogenicity and Antigen-Sparing with an AS03A-Adjuvanted Prepandemic Influenza Vaccine in a Thai Population
Prasert Thongcharoen MD*, Prasert Auewarakul MD*, Yanee Hutagalung MD**, Gary Ong MMed (Public Health), Dip (Fam Med)**, Paul Gillard MD**, Mamadou Drame MSc**, Hans L Bock MD**
Affiliation : * Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand ** GlaxoSmithKline Biologicals, Wavre, Belgium
Objective : The present study (NCT00449670) in Asian subjects (18-60 years) evaluated the manufacturing consistency of
four formulations of 3.75mg AS03A-adjuvanted H5N1 influenza vaccine, in terms of post-immunization Hemagglutination
Inhibition (HI) titers against the A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains. The immunogenicity and safety of the
vaccine in the Thai population are reported herein.
Material and Method: Subjects were randomized (2:2:2:2:1:1) between four vaccine groups and two control groups to
receive two doses of either the AS03A-adjuvanted or non-adjuvanted H5N1 vaccine formulations, 21 days apart. Sera were
assayed for HI antibody titers against the two strains.
Results : After the second dose of AS03A-adjuvanted vaccine, 94.2% subjects in the H5N1-AS03A groups seroconverted
and 94.9% subjects were seroprotected against the A/Vietnam/1194/2004 strain. Cross-clade immune response against the
A/Indonesia/05/2005 strain was observed. All vaccine formulations had an acceptable safety profile.
Conclusion : This antigen-sparing AS03A-adjuvanted influenza vaccine could be a suitable candidate for combating and
mitigating future influenza pandemics.
Keywords : H5N1, Thailand, Adjuvant System, Influenza, Prepandemic
