Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population
A multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03A-adjuvanted H5N1 vaccine in terms of immune response against the vaccine-homologous strain (A/Vietnam/1194/2004). This manus...
Main Authors: | , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2011-12-01
|
Series: | Journal of the Formosan Medical Association |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S0929664611001343 |
id |
doaj-f6bac8ae302b4301b0650b823c20e41b |
---|---|
record_format |
Article |
spelling |
doaj-f6bac8ae302b4301b0650b823c20e41b2020-11-24T22:32:40ZengElsevierJournal of the Formosan Medical Association0929-66462011-12-011101278078610.1016/j.jfma.2011.11.009Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese populationShinn-Jang Hwang0Shan-Chwen Chang1Chong-Jen Yu2Yu-Jiun Chan3Tzeng-Ji Chen4Shie-Liang Hsieh5Hsiu-Yun Lai6Ming-Hsien Lin7Jui-Yao Liu8Gary Ong9Francois Roman10Mamadou Dramé11Hans L. Bock12Pan-Chyr Yang13Taipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanNational Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, TaiwanNational Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanTaipei Veterans General Hospital, 201 Section 2, Shih-Pai Road, and National Yang Ming University School of Medicine, Taipei, TaiwanGlaxoSmithKline Biologicals, Wavre, BelgiumGlaxoSmithKline Biologicals, Wavre, BelgiumGlaxoSmithKline Biologicals, Wavre, BelgiumGlaxoSmithKline Biologicals, Wavre, BelgiumNational Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, TaiwanA multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03A-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-AS03A-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 AS03A-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-AS03A-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-AS03A-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 AS03A-adjuvanted H5N1 influenza vaccine formulations induced stronger immune response against the vaccine-homologous and heterologous strains than the nonadjuvanted formulations. The AS03A-adjuvanted H5N1 vaccine demonstrated a good immunogenicity and an acceptable safety profile in the Taiwanese population.http://www.sciencedirect.com/science/article/pii/S0929664611001343adjuvant systemdisease outbreakH5N1 virusinfluenza A virusTaiwan |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Shinn-Jang Hwang Shan-Chwen Chang Chong-Jen Yu Yu-Jiun Chan Tzeng-Ji Chen Shie-Liang Hsieh Hsiu-Yun Lai Ming-Hsien Lin Jui-Yao Liu Gary Ong Francois Roman Mamadou Dramé Hans L. Bock Pan-Chyr Yang |
spellingShingle |
Shinn-Jang Hwang Shan-Chwen Chang Chong-Jen Yu Yu-Jiun Chan Tzeng-Ji Chen Shie-Liang Hsieh Hsiu-Yun Lai Ming-Hsien Lin Jui-Yao Liu Gary Ong Francois Roman Mamadou Dramé Hans L. Bock Pan-Chyr Yang Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population Journal of the Formosan Medical Association adjuvant system disease outbreak H5N1 virus influenza A virus Taiwan |
author_facet |
Shinn-Jang Hwang Shan-Chwen Chang Chong-Jen Yu Yu-Jiun Chan Tzeng-Ji Chen Shie-Liang Hsieh Hsiu-Yun Lai Ming-Hsien Lin Jui-Yao Liu Gary Ong Francois Roman Mamadou Dramé Hans L. Bock Pan-Chyr Yang |
author_sort |
Shinn-Jang Hwang |
title |
Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population |
title_short |
Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population |
title_full |
Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population |
title_fullStr |
Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population |
title_full_unstemmed |
Immunogenicity and safety of an AS03A-adjuvanted H5N1 influenza vaccine in a Taiwanese population |
title_sort |
immunogenicity and safety of an as03a-adjuvanted h5n1 influenza vaccine in a taiwanese population |
publisher |
Elsevier |
series |
Journal of the Formosan Medical Association |
issn |
0929-6646 |
publishDate |
2011-12-01 |
description |
A multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03A-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-AS03A-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 AS03A-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-AS03A-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-AS03A-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 AS03A-adjuvanted H5N1 influenza vaccine formulations induced stronger immune response against the vaccine-homologous and heterologous strains than the nonadjuvanted formulations. The AS03A-adjuvanted H5N1 vaccine demonstrated a good immunogenicity and an acceptable safety profile in the Taiwanese population. |
topic |
adjuvant system disease outbreak H5N1 virus influenza A virus Taiwan |
url |
http://www.sciencedirect.com/science/article/pii/S0929664611001343 |
work_keys_str_mv |
AT shinnjanghwang immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT shanchwenchang immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT chongjenyu immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT yujiunchan immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT tzengjichen immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT shielianghsieh immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT hsiuyunlai immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT minghsienlin immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT juiyaoliu immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT garyong immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT francoisroman immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT mamadoudrame immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT hanslbock immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation AT panchyryang immunogenicityandsafetyofanas03aadjuvantedh5n1influenzavaccineinataiwanesepopulation |
_version_ |
1725732912847912960 |