A novel Staphylococcus aureus 4-antigen vaccine (SA4Ag) is under development, comprising capsular polysaccharide serotypes 5 and 8 (CP5 and CP8) conjugated to CRM, recombinant protein clumping factor A (rmClfA), and recombinant manganese transporter protein C (MntC). We evaluated SA4Ag safety, tolerability, and immunogenicity in Japanese adults aged 20 to 64 and 65 to 85 years. A total of 136 healthy Japanese adults (68 per age group) were randomized 1:1 to receive single-dose SA4Ag or placebo intramuscularly (Day 1). Safety assessments included reactogenicity and adverse events. The ability of the vaccine to induce immune responses that are considered functional due to their ability to facilitate the killing of S. aureus or neutralize S. aureus virulence mechanisms was assessed using 5 different antigen-specific assays. SA4Ag was well tolerated in both age groups, with no safety concerns. At Day 29, > 85% of SA4Ag recipients in each age group achieved predefined thresholds for each antigen. Antibody geometric mean-fold rises from baseline to Day 29 in SA4Ag groups were: > 80 and > 30 for CP5 and CP8 (opsonophagocytic activity assay), > 10 for ClfA (fibrinogen-binding inhibition assay), and > 15 and > 7 for ClfA and MntC (competitive Luminex® immunoassay), respectively. Antibody titers decreased through Month 12 but remained well above baseline and placebo levels. SA4Ag had an acceptable safety profile and induced rapid and robust functional immune responses in both age groups. These results support ongoing development of SA4Ag for the prevention of invasive S. aureus disease in elective-surgery patients in Japan, North America, and Europe.
Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference
product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated
biosimilarity between FKB327 and the reference product in safety profile, efficacy and
immunogenicity. FKB327 formulation excipients differ from the citrate-containing
formulation of the reference product, and injection-site pain differences have been
reported. The current analysis examines pooled data to assess the amount of
injection-site pain resulting from injecting FKB327 using a prefilled syringe,
autoinjector, or vial/syringe versus the reference product. Methods: Data from four
studies were pooled to compare injection-site pain upon subcutaneous administration of
FKB327 versus the reference product. Pooled data were analysed to compare FKB327 with
the reference product and to compare the autoinjector, pre-filled syringe and
vial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. A
linear mixed model of the injection-site pain visual analogue scale score across all
studies showed a 12.6-point lower pain score for FKB327 versus the reference product
(95% confidence interval, –14.3 to –10.8; p > 0.001). The autoinjector pain score was
4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p >
0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3
to –0.1; p = 0.035). No statistically significant differences were identified for
gender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showed
less injection-site pain compared with the reference product. No statistically
significant differences were seen in injection-site reactions or related adverse events
between FKB327 and the reference product or among FKB327 injection methods.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) is specified in its package insert to be taken with food to obtain sufficient exposure of EVG. It has been reported that a nutritional protein-rich drink shows comparable pharmacokinetics (PK) of EVG to those with a standard breakfast. In this study, the PK profiles of EVG and COBI were evaluated by administration of a single dose of EVG/COBI/FTC/TAF, after ingestion of either a nutritional protein-rich drink, milk, or apple juice. The geometric means for C and AUC of EVG following milk ingestion slightly decreased by 21% and 14%, respectively, and those following apple juice ingestion decreased by 67% and 61%, respectively, compared with a nutritional protein-rich drink. There were no differences in any PK parameters of COBI. Therefore, taking EVG/COBI/FTC/TAF after milk or apple juice ingestion appeared to be not appropriate. However, for plasma trough concentrations (C ), it is known that C is best correlated with the efficacy of EVG. The mean C of EVG after milk ingestion was 620.6 ng/mL, which was more than 10-fold the protein binding-adjusted 95% inhibitory concentration. With all the above considerations, it was concluded that taking EVG/COBI/FTC/TAF with milk could be an option to maintain sufficient plasma concentrations of EVG.
Coronavirus disease 2019 (COVID-19) has become a serious public health problem worldwide. In general, healthcare workers are considered to be at higher risk of COVID-19 infection. However, the prevalence of COVID-19 among healthcare workers in Japan is not well characterized. In this study, we aimed to examine the seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antibodies among 2160 healthcare workers in hospitals and clinics that are not designated to treat COVID-19 patients in Japan. The prevalence of SARS-CoV-2 immunoglobulin G was 1.2% in August and October 2020 (during and after the second wave of the pandemic in Japan), which is relatively higher than that in the general population in Japan (0.03–0.91%). Because of the higher risk of COVID-19 infection, healthcare workers should be the top priority for further social support and vaccination against SARS-CoV-2.
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