Hwang S.-J.SHAN-CHWEN CHANGCHONG-JEN YUChan Y.-J.Tzeng-Ji ChenHsieh S.-L.Lai H.-Y.Lin M.-H.Liu J.-Y.Ong G.Roman F.Dramé M.Bock H.L.PAN-CHYR YANG2020-12-302020-12-3020110929-6646https://www.scopus.com/inward/record.uri?eid=2-s2.0-84855829175&doi=10.1016%2fj.jfma.2011.11.009&partnerID=40&md5=d2802d78832b7836909998b2a9d746b2https://scholars.lib.ntu.edu.tw/handle/123456789/536162Background/Purpose: A multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03 A-adjuvanted H5N1 vaccine in terms of immune response against the vaccine-homologous strain (A/Vietnam/1194/2004). This manuscript presents data from the Taiwanese population. Methods: A total of 400 individuals, aged 18-60 years, were randomized into six groups (2:2:2:2:1:1 ratio) to receive two doses (21 days apart) of one of the four adjuvanted formulations (H5N1-AS03 A-groups) or one of the two nonadjuvanted formulations (H5N1-DIL-groups). Blood samples collected before vaccination (Day 0) and 21 days after each vaccine dose were analyzed using hemagglutination inhibition (HI) assay. Adverse events were recorded. Results: All four AS03 A-adjuvanted formulations induced comparable immune responses against the A/Vietnam/1194/2004 strain; following the second dose, immune response in terms of HI antibodies was higher in the H5N1-AS03 A-groups {seroprotection rate=91.6% [95% confidence interval (CI): 87.9-94.4]; geometric mean titer (GMT)=177.6 (95% CI: 153.2-206.0)} compared with the H5N1-DIL-groups [seroprotection rates=5.0% (95% CI: 1.4-12.3); GMT=6.3 (95% CI: 5.4-7.4)]. Immune response against the heterologous A/Indonesia/05/2005 strain was also stronger in the H5N1-AS03 A-groups [seroprotection rate=45.6% (95% CI: 40.0-51.4); GMT=20.5 (95% CI: 17.8-23.7)] compared with the H5N1-DIL groups [seroprotection rate=0.0% (95% CI: 0.0-4.5); GMT=5.0 (95% CI: 5.0-5.0)]. The overall reactogenicity profile of the adjuvanted formulations was clinically acceptable. Conclusion: The AS03 A-adjuvanted H5N1 influenza vaccine formulations induced stronger immune response against the vaccine-homologous and heterologous strains than the nonadjuvanted formulations. The AS03 A-adjuvanted H5N1 vaccine demonstrated a good immunogenicity and an acceptable safety profile in the Taiwanese population. ? 2011.[SDGs]SDG3influenza vaccine; abdominal pain; adult; arthralgia; article; asthenia; blood sampling; confidence interval; controlled study; dizziness; drug safety; ecchymosis; fatigue; female; fever; headache; hemagglutination inhibition test; Hong Kong; human; immune response; immunogenicity; Indonesia; lethargy; major clinical study; male; multicenter study; myalgia; nausea; pain; phase 3 clinical trial; population research; randomized controlled trial; serology; shivering; side effect; Singapore; single blind procedure; skin induration; skin redness; sore throat; sweating; swelling; Taiwan; Thailand; vaccination; Viet Nam; virus strain; Adjuvants, Immunologic; Adolescent; Adult; Antibodies, Viral; Double-Blind Method; Female; Hemagglutinin Glycoproteins, Influenza Virus; Humans; Influenza A Virus, H5N1 Subtype; Influenza Vaccines; Male; Middle Aged; Taiwan; Tocopherolsjournal article10.1016/j.jfma.2011.11.00922248833