Immunogenicity of a monovalent pandemic influenza A H1N1 vaccine in health-care workers of a university hospital in Japan.
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.
Chiba University Hospital, Inohana, Chuo-ku, Japan. igari@faculty.chiba-u.jp
Hidetoshi
H
Igari
Shunsuke
S
Segawa
Akira
A
Watanabe
Akiko
A
Suzuki
Mariko
M
Watanabe
Takayuki
T
Sakurai
Fuminobu
F
Kuroda
Masaharu
M
Watanabe
Koichiro
K
Tatsumi
Mikio
M
Nakayama
Toshinori
T
Nakayama
Kazuo
K
Suzuki
Takeyuki
T
Sato
D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006282:Health Personnel; D006785:Hospitals, University; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007564:Japan; D008297:Male; D008875:Middle Aged; D058873:Pandemics; D011446:Prospective Studies; D014611:Vaccination
D000914:Antibodies, Viral; D007252:Influenza Vaccines