Monkeypox (mpox) is an acute exanthematous disease caused by the monkeypox virus (MPXV). Since May 2022, patients with mpox have been reported worldwide, mainly in Europe and the Americas. In Japan, LC16”KMB,” which is a smallpox vaccine derived from a dried cell culture, against mpox, has been approved. Although inoculation with a smallpox vaccine has been recommended to prevent MPXV infection, the immunogenicity of the smallpox vaccine against the MPXV is unclear, and information regarding postvaccination safety is scarce. We present the protocol for a single-arm open-label study to investigate the immunogenicity and safety of LC16”KMB” against the MPXV in healthy Japanese adults. The primary endpoint is the seroconversion rate of neutralizing antibodies against the MPXV on postvaccination day 28. The secondary endpoints are the seroconversion rates against the MPXV on postvaccination days 14 and 168; the seroconversion rates against the vaccinia virus on postvaccination days 14, 28, and 168; the incidence of mpox until day 168; and adverse and serious adverse events until postvaccination days 28 and 168. These results will pave the way for larger comparative studies using other smallpox vaccines to evaluate the test vaccine’s safety and efficacy in preventing mpox.
In response to the vaccine shortage of yellow fever vaccine (YF-VAX) due to manufacturing delays, the unapproved 17D-204 YF-VAX was used as an investigator-initiated clinical trial in Japan. The vaccine was administered to 11,279 participants in 19 YF vaccination centers in Japan, and few serious adverse events were observed.
BackgroundWith the rapid increase in the number of COVID-19 patients in Japan, the number of patients receiving oxygen at home has also increased rapidly, and some of these patients have died. An efficient approach to identify high-risk patients with slowly progressing and rapidly worsening COVID-19, and to avoid missing the timing of therapeutic intervention will improve patient prognosis and prevent medical complications.MethodsPatients admitted to medical institutions in Japan from November 14, 2020 to April 11, 2021 and registered in the COVID-19 Registry Japan were included. Risk factors for patients with High Flow Nasal Cannula invasive respiratory management or higher were comprehensively explored using machine learning. Age-specific cohorts were created, and severity prediction was performed for the patient surge period and normal times, respectively.ResultsWe were able to obtain a model that was able to predict severe disease with a sensitivity of 57% when the specificity was set at 90% for those aged 40-59 years, and with a specificity of 50% and 43% when the sensitivity was set at 90% for those aged 60-79 years and 80 years and older, respectively. We were able to identify lactate dehydrogenase level (LDH) as an important factor in predicting the severity of illness in all age groups.DiscussionUsing machine learning, we were able to identify risk factors with high accuracy, and predict the severity of the disease. Using machine learning, we were able to identify risk factors with high accuracy, and predict the severity of the disease. We plan to develop a tool that will be useful in determining the indications for hospitalisation for patients undergoing home care and early hospitalisation.
Background Japan has one of the most aging societies in the world. Urinary tract infection (UTI) is a common disease in the elderly, and the incidence of hospitalization owing to UTI is increasing with the aging population. Here, we examined the length of hospital stay, differences in the Barthel index (BI), activities of daily living score (ADLs) at admission and discharge, and medical costs of UTI in elderly patients. Methods We retrospectively included hospitalized UTI patients in our center between January 1, 2013 and March 31, 2019. The inclusion criteria were as follows: (1) urine culture positive for Escherichia coli (over 104 colony forming units/mL) within 48 h of admission, and (2) the presence of at least one of the following: fever ≥ 38°C, costovertebral angle tenderness, suprapubic tenderness, and dysuria at the time of admission. We classified the enrolled patients into four groups according to age: young adults (20–64 years), pre-old (65–74 years), old (75–84 years), and super-old (≥ 85 years). Patient characteristics were compared across groups using the Mann–Whitney U test, Fisher’s exact test, and Kruskal-Wallis test. The Bonferroni corrected P < 0.05 was considered statistically significant. Results This study enrolled 393 cases, including 112 (28.4%) young adults, 72 (18.3%) pre-old, 130 (33.2%) old, and 79 (20.1%) super-old. The lengths of hospital stay were 10.8, 17.9, 17.2, and 21.6 days in young adults, pre-old, old, and super-old, respectively (P < 0.05). Differences in the BI were 1.2, 4.2, 5.2, and 5.2 in young adults, pre-old, old, and super-old, respectively (P < 0.05). However, no significant differences in these values were noted among the pre-old, old, and super-old groups. The medical costs were 6,054, 8,310, 10,129, and 12,577-USD (1USD = 128 yen) in young adults, pre-old, old, and super-old, respectively (P < 0.05). Nevertheless, a comparison of the medical costs per day showed no significant differences among the groups. Conclusion UTI in elderly patients were associated with ADLs decline, longer hospital stays, and higher medical costs than those in younger patients; however, no significant differences were found among those aged ≥ 65 years. Disclosures Sho Saito, MD, PhD, DAIICHI SANKYO: Grant/Research Support|EVEC: Grant/Research Support|EVEC: Patents obtained through collaborative research|SHIONOGI: Grant/Research Support|Takeda: Advisor/Consultant.
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