Japanese subgroup analysis of GLIMMER: A global Phase IIb study of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

Aim: To compare patient characteristics and outcomes between the overall and Japanese populations of GLIMMER.

Methods: GLIMMER was a multicenter, double-blind, randomized, placebo-controlled, Phase IIb study evaluating linerixibat for the treatment of pruritus in patients with primary biliary cholangitis.

Results: In total, 147 patients were randomized in the GLIMMER overall population with 38 patients comprising the Japanese population.

Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study.

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded.

Orally administered Bifidobacterium triggers immune responses following capture by CD11c(+) cells in Peyer's patches and cecal patches.

We have investigated the immunomodulatory mechanisms of Bifidobacterium pseudocatenulatum JCM7041 (Bp) as model of probiotics following oral administration to mice. This study was conducted with the aim of clarifying the mechanism of immunomodulation induced by oral administration of probiotic bacteria through elucidation of the detailed mechanism of transfer of orally administered bacterial cells within the body and the interaction between bacterial cells and cells of the immune tissues. We observed the localization of Bp in mice following oral administration, showing that Bp was surrounded by CD11c(+) cells in Peyer's patches (PP) and cecal patches (CP).