| RRC ID |
46962
|
| 著者 |
Igari H, Segawa S, Watanabe A, Suzuki A, Watanabe M, Sakurai T, Kuroda F, Watanabe M, Tatsumi K, Nakayama M, Nakayama T, Suzuki K, Sato T.
|
| タイトル |
Immunogenicity of a monovalent pandemic influenza A H1N1 vaccine in health-care workers of a university hospital in Japan.
|
| ジャーナル |
Microbiol Immunol
|
| Abstract |
A phase III observational study evaluating a single-dose of an inactivated, split-virus, unadjuvanted AH1pdm vaccine in HCW was conducted. A safe and effective vaccine was needed after the emergence of AH1pdm in April 2009. We analyzed the immunogenicity and safety of the vaccine. A total of 409 subjects were enrolled and given 15 μg hemagglutinin antigen by s.c. injection. Antibody titers were measured using hemagglutination-inhibition antibody assays before vaccination and 28 days after. The co-primary immunogenicity end-points were the proportion of subjects with antibody titers of 1:40 or more, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in geometric mean titer. We collected 389 pair samples. Antibody titers of 1:40 or more were observed in 148 of 389 subjects (38.0%, 95% CI: 33.2-42.9). The immunogenicity was also confirmed in other end-points, but was not sufficient and was lower than in previous reports. A total of 96 of adverse events was reported: 51 local events and 57 systemic events. There were 12 subjects with both local and systemic events. Nearly all events were mild to moderate except in four subjects. A single 15-μg dose of AH1pdm vaccine did not induce sufficient immunogenicity in HCW, with mild-to-moderate vaccine-associated adverse events. We need to consider further improvement of the AH1pdm vaccine program in HCW for the prevention of nosocomial infection, as well as for the benefit of HCW.
|
| 巻・号 |
54(10)
|
| ページ |
618-24
|
| 公開日 |
2010-10-1
|
| DOI |
10.1111/j.1348-0421.2010.00254.x
|
| PMID |
21118299
|
| MeSH |
Adult
Aged
Antibodies, Viral / blood
Female
Health Personnel*
Hospitals, University
Humans
Influenza A Virus, H1N1 Subtype / immunology*
Influenza Vaccines / adverse effects
Influenza Vaccines / immunology*
Japan
Male
Middle Aged
Pandemics
Prospective Studies
Vaccination
|
| IF |
1.566
|
| 引用数 |
12
|
|
WOS 分野
|
MICROBIOLOGY
IMMUNOLOGY
|
| リソース情報 |
| 病原微生物 |
|
