Adverse events after administration of the first and second doses of messenger RNA-based COVID-19 vaccines in Japanese subjects aged 12-18 years.

OBJECTIVE: Using a prospective observational design, we assessed adverse events (AEs) after COVID-19 vaccination in Japanese patients. METHODS: Two doses of the mRNA-1273 (SPIKEVAX®) or BNT162b2 (COMIRNATY®) vaccine were administered to participants aged 12 to 18 years, and AEs after each dose were recorded for 14 days. Data on the duration and nature (local vs. systemic) of AEs were collected using a questionnaire. Sex-based differences in AE frequency were also analyzed. RESULTS: After the first and second doses, 152 and 135 vaccinees were enrolled, respectively. After the first dose, fever (>37.1°C) occurred in 38.9% of males and 50.0% of females, whereas local pain occurred in 89.8% and 97.7% of males and females, respectively (only SPIKEVAX® was used as the first dose). After the second dose, fever (>37.1°C) occurred in 77.8% and 82.6% of males vaccinated with COMIRNATY® and SPIKEVAX®, respectively, and 82.6% of females (all received SPIKEVAX®). The local pain rates in these groups were 80.6%, 76.3%, and 100%, respectively. After the second dose, local pain, fever (>38.1°C) and headache were significantly more common in female participants, and the median symptom duration was 3 days. CONCLUSIONS: AEs were more frequent after the second dose and in females.

Association between history of HBV vaccine response and anti-SARS-CoV-2 spike antibody response to the BioNTech/Pfizer's BNT162b2 mRNA SARS-CoV-2 vaccine among healthcare workers in Japan: A prospective observational study.

INTRODUCTION: Inadequate vaccine response is a common concern among healthcare workers at the frontlines of the COVID-19 pandemic. We aimed to investigate if healthcare workers with history of weak immune response to HBV vaccination are more likely to have weak responses against the BioNTech/Pfizer's BNT162b2 mRNA SARS-CoV-2 vaccine. METHODS: We prospectively tested 954 healthcare workers for the Anti-SARS-CoV-2 spike (S) protein antibody titers prior to the first and second BNT162b2 vaccination doses and after four weeks after the second dose using Roche's Elecsys® assay. We calculated the percentage of patients who seroconverted after the first and second doses. We estimated the relative risk of non-seroconversion after the first BNT162b2 vaccine (defined as anti-SARS-CoV-2-S titer <15 U/mL) among HBV vaccine non-responders (HBs-Ab titer <10 mIU/mL) and weak responders (≥10 and <100 mIU/mL) compared to normal responders (≥100 mIU/mL). RESULTS: Among 954 healthcare workers recruited between March 9 and March 24, 2021 at Osaka Medical and Pharmaceutical University, weak and normal HBV vaccine responders had comparable S-protein titers after the first BNT162b2 dose (51.4 [95% confidence interval 25.2-137.0] versus 59.7 [29.8-138.0] U/mL, respectively). HBV vaccine non-responders were more likely than normal responders to not seroconvert after a single dose (age and sex-adjusted relative risk 1.85 95% confidence interval [1.10-3.13]) although nearly all participants seroconverted after the second dose. After limiting the analysis to 382 patients with baseline comorbidity data, the comorbidity-adjusted relative risk of non-seroconversion among HBV vaccine non-responders to normal responders was 1.32 (95% confidence interval [0.59-2.98]). DISCUSSION: Long term follow-up studies are needed to understand if protective immunity against SARS-CoV-2 wanes faster among those with history of HBV vaccine non-response and when booster doses are warranted for these healthcare workers.

Effect of the introduction of a management bundle for blood culture collection.

BACKGROUND: Inappropriate blood collection subjected to blood culture (BC) causes BC contamination and may complicate the diagnose is of infectious diseases. Therefore, we developed a bundle based on the guideline recommendations for appropriate blood collection and examined the effects of bundle introduction. METHODS: We performed a retrospective analysis of BC samples to determine the contamination rates before and after introducing the BC bundle. We also analyzed the correlation between the compliance rate of the bundle and contamination rate, and between each bundle element and contamination. RESULTS: After the introduction of the bundle, the contamination rate was significantly reduced from 5.4% ± 0.9% to 1.7± 0.7% (P < .01). The compliance rate of the bundle was significantly associated with a lower contamination rate (P < .01). Multivariable logistic regression showed that collection from superficial veins of the cubital fossa (odds ratio [OR], 0.25; 95% confidence interval [CI], 0.13-0.51, P < .01) and disinfection of the skin at the blood collection site with 1% chlorhexidine alcohol swab (OR, 0.41; 95% CI, 0.25-0.68, P < .01) were significantly associated with lower contamination. CONCLUSIONS: This study suggests that the introduction of the BC bundle significantly reduced the contamination rate, and bundle compliance was associated with a lower contamination rate.

Observational study to determine the optimal dose of daptomycin based on pharmacokinetic/pharmacodynamic analysis.

High doses of daptomycin (DAP) (>6 mg/kg/day) have been preliminarily recommended in recent practical guidelines for methicillin-resistant Staphylococcus aureus infection, to achieve better clinical effects. While such doses can elevate the plasma trough concentration (Cmin) of DAP, there is an associated risk of creatine phosphokinase (CPK) elevation warranting further investigation. In the current study relationships between DAP Cmin and CPK elevation were investigated, and optimal DAP doses were determined. Plasma DAP concentrations were measured in 20 patients. Logistic regression analysis was performed to assess relationships between DAP Cmin and CPK elevation, then a population pharmacokinetic model of DAP was developed. To determine an optimal DAP dose a Monte Carlo simulation (MCS) was performed to minimize the risk of CPK elevation and maximize the probability of successful treatment. In logistic regression analysis DAP Cmin was significantly associated with CPK elevation (odds ratio 1.21, p = 0.048). With respect to dose-dependent increases in the probability of CPK elevation and exposure to DAP, MCS estimated an optimal DAP dose of 4-6 mg/kg/day, corresponding to a minimum inhibitory concentration (MIC) of ≤0.5 µg/mL. For an MIC of 1 µg/mL, MCS estimated an optimal DAP dose of 10 mg/kg/day. However, the probability of CPK elevation associated with high doses of DAP was higher than that associated with the approved doses. In cases where high doses of DAP are administered, close CPK monitoring is required and therapeutic drug monitoring of DAP may be desirable.

Risk factors for ventilator-associated pneumonia in neonatal intensive care unit patients.

Ventilator-associated pneumonia (VAP) is a serious complication in neonatal patients on mechanical ventilation. The objective of this study was to examine the incidence and risk factors associated with VAP, particularly in every 7-day versus every 14-day ventilator circuit changes, in a neonatal intensive care unit (NICU). Seventy-one neonates hospitalized in the NICU were enrolled. First, the neonates were divided into groups with and without VAP. On univariate logistic regression analyses, prolonged mechanical ventilation, frequent re-intubation, low gestational age, and low birth weight (BW) were significant risk factors for VAP development. After adjustments for other variables, only BW <626 g was a significant independent predictor for VAP in NICU infants. Second, to examine the effect of the frequency of changing ventilator circuits on the incidence of VAP, circuit changes were compared between the every 7-day group and the every 14-day group. The incidence of VAP per 1000 ventilator days was 9.66 for the every 7-day group and 8.08 for the every 14-day group, and there was no significant difference between the 2 groups. BW <626 g was a significant independent predictor of VAP, and decreasing the frequency of ventilator circuit changes from every 7 days to 14 days had no adverse effect on the VAP rate in the NICU.

[Effectiveness of intervention by the infection control team for cancer patients with a positive blood culture].

Cancer patients at a high risk of acquiring infectious diseases should be maintained in a facility where good infection control practices are followed. At our hospital, the infection control team(ICT)provides expertise, education, and support to the staff, helping them maintain proper standards, thereby minimizing the risks of infection. The ICT(established in 2004)has implemented infection control programs by employing an appropriate number of staff members after the revision of medical treatment fees in 2011. Our intervention program includes 2 general policies, namely, ordering and collection of blood cultures and intervention for the medical care of patients with positive blood cultures. In this study, we evaluated the effectiveness of our intervention for cancer patients with a positive blood culture. During the surveillance period(April 2011 to July 2012), 42 positive cases were determined to be infectious. ICT intervention was required in 37 cases. Our suggestions were accepted in 92%(34/37)of the cases, and improved outcome was estimated in 65%(22/34)of the cases. The results of our study contribute to the scientific bases on which routine clinical practices could be promoted in the future.