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Diminished immunogenicity to pandemic H1N1 2009 influenza vaccine in subjects with severe motor and intellectual disability
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Megumi Haraa, Corresponding Author Contact Information, E-mail The Corresponding Author, Tomoyuki Hanaokab, c, d, Takashi Mizushimab, Junya Honmab, Kazuhiro Maedae, Satoko Ohfujif, Keitaro Tanakaa and Yoshio Hirotaf
a Department of Preventive Medicine, Faculty of Medicine, Saga University, 5-1-1 Nabeshima, Saga City, Saga 849-8501, Japan
b Bihoro Ryoiku Hospital, 9 Mitomi Bihoro, Hokkaido 092-0030, Japan
c Department of Hygiene and Preventive Medicine, Showa University, School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
d Hokkaido University Center for Environmental and Health Sciences, 7 Kita-Junijo-Nishi, Sapporo City, Hokkaido 060-0812, Japan
e The Research Foundation for Microbial Diseases of Osaka University, Kannonnji Kagawa, Japan
f Department of Public Health, Faculty of Medicine, Osaka City University,1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Received 16 March 2011;
revised 14 July 2011;
accepted 19 August 2011.
Available online 3 September 2011.
Abstract
Subjects with severe motor and intellectual disability (SMID) are considered to be debilitated and at high risk of influenza infection. However, the safety and immunogenicity of pandemic H1N1 (pH1N1) vaccine in these subjects have not been reported. We measured the hemagglutination inhibition antibody titer and calculated the geometric mean titer ratio (GMTR), seroprotection rate, and seroconversion rate in 104 subjects with SMID (mean age ? standard deviation 40.1 ? 12.9 years), and in 179 healthcare workers (40.7 ? 10.4 years) in a long-term care facility. Antibody responses after the first dose of pH1N1 vaccine among workers were greater than the European Medicines Evaluation Agency criteria and US Food and Drug Administration (FDA) criteria: the seroprotection rate was 79.9% (95% confidence interval (CI) 73.3?85.5), the seroconversion rate was 77.9% (95%CI: 70.8?84.0), and GMTR was 7.3 (95%CI: 6.9?7.8). Responses among subjects with SMID were lower than the FDA criteria: the seroprotection rate was 56.3% (95%CI: 46.2?66.1), the seroconversion rate was 54.1% (95%CI: 43.7?64.2), and GMTR was 5.4 (95%CI: 4.9?5.9). Any additional antibody response induced by the second dose of vaccine among subjects with SMID was limited. Multivariate analysis indicated that subjects with SMID had a significantly lower seroprotection rate (odds ratio (OR) 0.37, 95%CI: 0.20?0.66) and seroconversion rate (OR 0.34, 95%CI: 0.20?0.59) than healthcare workers. No serious adverse reaction was reported in either group. These results indicate that a single dose of pH1N1 vaccine does not induce sufficient immunity among subjects with SMID, and a second dose is likely to be ineffective because of diminished immunogenicity. Further study is required to determine if vaccination over consecutive influenza seasons can improve immunogenicity in subjects with SMID.
Highlights
► Subjects with severe motor and intellectual disability are at high risk of influenza. ► Immunogenicity after single dose of pH1N1 vaccine was lower than the FDA criteria. ► Any additional antibody response induced by the second dose of vaccine was limited.
http://www.sciencedirect.com/science/article/pii/S0264410X11013673
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Megumi Haraa, Corresponding Author Contact Information, E-mail The Corresponding Author, Tomoyuki Hanaokab, c, d, Takashi Mizushimab, Junya Honmab, Kazuhiro Maedae, Satoko Ohfujif, Keitaro Tanakaa and Yoshio Hirotaf
a Department of Preventive Medicine, Faculty of Medicine, Saga University, 5-1-1 Nabeshima, Saga City, Saga 849-8501, Japan
b Bihoro Ryoiku Hospital, 9 Mitomi Bihoro, Hokkaido 092-0030, Japan
c Department of Hygiene and Preventive Medicine, Showa University, School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
d Hokkaido University Center for Environmental and Health Sciences, 7 Kita-Junijo-Nishi, Sapporo City, Hokkaido 060-0812, Japan
e The Research Foundation for Microbial Diseases of Osaka University, Kannonnji Kagawa, Japan
f Department of Public Health, Faculty of Medicine, Osaka City University,1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Received 16 March 2011;
revised 14 July 2011;
accepted 19 August 2011.
Available online 3 September 2011.
Abstract
Subjects with severe motor and intellectual disability (SMID) are considered to be debilitated and at high risk of influenza infection. However, the safety and immunogenicity of pandemic H1N1 (pH1N1) vaccine in these subjects have not been reported. We measured the hemagglutination inhibition antibody titer and calculated the geometric mean titer ratio (GMTR), seroprotection rate, and seroconversion rate in 104 subjects with SMID (mean age ? standard deviation 40.1 ? 12.9 years), and in 179 healthcare workers (40.7 ? 10.4 years) in a long-term care facility. Antibody responses after the first dose of pH1N1 vaccine among workers were greater than the European Medicines Evaluation Agency criteria and US Food and Drug Administration (FDA) criteria: the seroprotection rate was 79.9% (95% confidence interval (CI) 73.3?85.5), the seroconversion rate was 77.9% (95%CI: 70.8?84.0), and GMTR was 7.3 (95%CI: 6.9?7.8). Responses among subjects with SMID were lower than the FDA criteria: the seroprotection rate was 56.3% (95%CI: 46.2?66.1), the seroconversion rate was 54.1% (95%CI: 43.7?64.2), and GMTR was 5.4 (95%CI: 4.9?5.9). Any additional antibody response induced by the second dose of vaccine among subjects with SMID was limited. Multivariate analysis indicated that subjects with SMID had a significantly lower seroprotection rate (odds ratio (OR) 0.37, 95%CI: 0.20?0.66) and seroconversion rate (OR 0.34, 95%CI: 0.20?0.59) than healthcare workers. No serious adverse reaction was reported in either group. These results indicate that a single dose of pH1N1 vaccine does not induce sufficient immunity among subjects with SMID, and a second dose is likely to be ineffective because of diminished immunogenicity. Further study is required to determine if vaccination over consecutive influenza seasons can improve immunogenicity in subjects with SMID.
Highlights
► Subjects with severe motor and intellectual disability are at high risk of influenza. ► Immunogenicity after single dose of pH1N1 vaccine was lower than the FDA criteria. ► Any additional antibody response induced by the second dose of vaccine was limited.
http://www.sciencedirect.com/science/article/pii/S0264410X11013673