title: Long-Term Immunogenicity and Safety of a Conventional Influenza Vaccine in Patients with Type 2 Diabetes.
abstract: No previous studies have assessed the persistence of immune responses in individuals with diabetes. We conducted this study to evaluate the long-term immunogenicity and safety of an influenza vaccine in type 2 diabetic subjects compared with nondiabetic controls. A randomized and controlled study was conducted at two university hospitals during the 2012-2013 influenza season. The study vaccine was a standard-dose trivalent subunit inactivated intramuscular vaccine. Serum hemagglutination-inhibiting (HI) antibodies were measured at the time of vaccination and 1 month and 6 months after vaccination. Local and systemic reactions were recorded for 7 days. A total of 105 diabetic patients and 108 controls were included in the analysis. One month after vaccination, both the diabetic and nondiabetic groups satisfied all of the criteria of the Committee for Medical Products for Human Use (CHMP), and the immunogenicity profiles were statistically similar between the two groups. Although the vaccine was well tolerated, and all adverse reactions were mild to moderate, there was a tendency toward a reduced incidence of local reactions in the diabetic group. All values in the long-term immunogenicity profiles were statistically similar between the two groups, except for the seroprotection rate for the A/H1N1 influenza virus strain, which was significantly lower in the elderly diabetic group than that in the elderly nondiabetic group. However, in multivariate analysis, long-term immunogenicity was associated with age and prevaccination titer, regardless of diabetes status. (This study has been registered at CRIS [https://cris.nih.go.kr/cris/en/] under registration no. KCT0001423.).
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea.
authors.forename: Yu Bin
authors.initials: YB
authors.lastname: Seo
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea.
authors.forename: Ji Hyeon
authors.initials: JH
authors.lastname: Baek
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea.
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Joon Young
authors.initials: JY
authors.lastname: Song
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea.
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea heejinmd@korea.ac.kr.
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
mesh_terms: D000276:Adjuvants, Immunologic; D000367:Age Factors; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000276:immunology*; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D000069078:Seroconversion; D014611:Vaccination / Q000009:adverse effects
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines