Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) in Meningococcal Vaccine-Naïve Participants across a Broad Age Range (2-55 Years) in Japan: a Phase III Randomized Study.

MenACYW-TT is a quadrivalent meningococcal tetanus toxoid-conjugate vaccine designed to prevent invasive meningococcal disease. The primary objective of this study was to demonstrate non-inferiority of the vaccine seroresponse to a single dose of MenACYW-TT compared with MCV4-DT, a licensed meningococcal quadrivalent diphtheria-conjugate vaccine. This Phase III double-blind, multicenter trial was conducted in meningococcal vaccine-naïve individuals aged 2-55 years in Japan (NCT04368429; jRCT2080225192). Participants were randomized 1:1 to receive either MenACYW-TT (n = 180) or MCV4-DT (n = 180). Functional antibodies against meningococcal serogroups A, C, W, and Y were measured using a serum bactericidal antibody assay with human complement (hSBA) at baseline (D0) and 30 days after vaccination (D30). Seroresponse was defined as a post-vaccination titer ≥1:16 in participants with a baseline titer <1:8; or a ≥4-fold increase in titer in participants with a baseline titer ≥1:8. Safety data were collected for 30 days. Non-inferiority of the seroresponse to MenACYW-TT vs. MCV4-DT was demonstrated on D30 for each serogroup tested (A: 85.6% vs. 65.4%; C: 96.6% vs. 62.6%; W: 87.4% vs. 49.2%; Y: 97.7% vs. 63.5%). MenACYW-TT was well tolerated with no safety concerns identified. A single dose of MenACYW-TT was well tolerated, with a non-inferior seroresponse compared with MCV4-DT. MenACYW-TT could thus be used as an alternative vaccine in meningococcal vaccine-naïve individuals.

Prevalence and predictors of atrial fibrillation in Japanese patients with type 2 diabetes.

INTRODUCTION: Close association has been shown between diabetes and atrial fibrillation (AF). We conducted this single-center cross-sectional study to investigate the prevalence and predictors of AF in Japanese patients with type 2 diabetes. PATIENTS AND METHODS: Patients with type 2 diabetes were eligible if 12-lead electrocardiograms were recorded at the first visit between January 2004 and December 2005. The prevalence of AF in the patients was compared with that in the Japanese general population. Multivariate logistic regression analysis was conducted to determine the effect of independent variables on the prevalence of AF and non-valvular AF. RESULTS: 1650 patients with type 2 diabetes, 588 women and 1,059 men, with the mean age of 60 ± 13 (SD) years were studied. Among them, 72 patients had AF, accounting for 4.4%, with a sex-specific prevalence of 2.5% in women and 5.4% in men. Of the 72 patients having AF, 12 patients had valvular AF and 60 patients had nonvalvular AF. When compared with the Japanese general population, the age- and sex-adjusted risk ratio for AF was 3.47 (95% confidence interval: 2.77-4.37). The prevalence of combined nonvalvular/valvular AF and nonvalvular AF increased with age. Other relevant factors associated with AF and nonvalvular AF were male sex, presence of hypertension, and decreased platelet count. CONCLUSION: Higher prevalence of AF was observed in Japanese patients with type 2 diabetes than the general population. Advanced age, male sex, and hypertension were independent predictive factors for AF.