A novel influenza A (H1N1) vaccine in various age groups.
BACKGROUND
There is an urgent need for a vaccine that is effective against the 2009 pandemic influenza A (H1N1) virus.


METHODS
A split-virus, inactivated candidate vaccine against the 2009 H1N1 virus was manufactured, and we evaluated its safety and immunogenicity in a randomized clinical trial. Subjects were between 3 and 77 years of age, stratified into four age groups. The immunization schedule consisted of two vaccinations, 21 days apart. Subjects were injected with placebo or with vaccine, with or without alum adjuvant, at doses of 7.5 microg, 15 microg, or 30 microg. Serologic analysis was performed at baseline and on days 21 and 35.


RESULTS
A total of 2200 subjects received one dose, and 2103 (95.6%) received the second dose, of vaccine or placebo. No severe adverse side effects associated with the vaccine were noted. In the nonadjuvanted-vaccine groups, injection-site or systemic reactions, most mild in nature, were noted in 5.5 to 15.9% of subjects. Among the subjects receiving 15 microg of nonadjuvanted vaccine, a hemagglutination-inhibition titer of 1:40 or more was achieved by day 21 in 74.5% of subjects between 3 and 11 years of age, 97.1% of subjects between 12 and 17 years, 97.1% of subjects between 18 and 60 years, and 79.1% of subjects 61 years of age or older; by day 35, the titer had been achieved in 98.1%, 100%, 97.1%, and 93.3% of subjects, respectively. The proportion with a titer of 1:40 or more was generally highest among the subjects receiving 30 microg of vaccine, with or without adjuvant. Vaccine without adjuvant was associated with fewer local reactions and greater immune responses than was vaccine with adjuvant.


CONCLUSIONS
These data suggest that a single dose of 15 microg of hemagglutinin antigen without alum adjuvant induces a typically protective immune response in the majority of subjects between 12 and 60 years of age. Lesser immune responses were seen after a single dose of vaccine in younger and older subjects. (ClinicalTrials.gov number, NCT00975572).
Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Feng-Cai
FC
Zhu
Hua
H
Wang
Han-Hua
HH
Fang
Jian Guo
JG
Yang
Xiao Jun
XJ
Lin
Xiao-Feng
XF
Liang
Xue-Feng
XF
Zhang
Hong-Xing
HX
Pan
Fan-Yue
FY
Meng
Yue Mei
YM
Hu
Wen-Dong
WD
Liu
Chang-Gui
CG
Li
Wei
W
Li
Xiang
X
Zhang
Jin Mei
JM
Hu
Wei Bing
WB
Peng
Bao Ping
BP
Yang
Pei
P
Xi
Hua-Qing
HQ
Wang
Jing-Shan
JS
Zheng
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000534:Alum Compounds / Q000008:administration & dosage; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006389:Hemagglutinins, Viral / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000534:Alum Compounds; D000914:Antibodies, Viral; D006389:Hemagglutinins, Viral; D007252:Influenza Vaccines; C041524:aluminum sulfate