Introduction: The use of novel mRNA platforms for COVID-19 vaccines raised concern about vaccine safety, especially in Asian populations that made up less than 10% of study populations in the pivotal vaccine trials used for emergency use authorisation. Vaccine safety issues also remain a concern in assessing the clinical risks and benefits of vaccine boosters, particularly in specific age groups or segments of the population. This study describes a vaccination exercise involving Asian military personnel, and the adverse reactions and safety events observed. Methods: Minor adverse reactions, hospitalisations and adverse events of special interest were monitored as part of the organisation’s protocol for safety monitoring of COVID-19 vaccinations. All vaccine recipients were invited to complete an online adverse reaction questionnaire. Medical consults at the military’s primary healthcare facilities were monitored for vaccine-related presentations. All hospitalisations involving vaccine recipients were analysed. Adverse reaction rates between doses, vaccines and age groups were compared. Results: A total of 127,081 mRNA vaccine doses were administered to 64,661 individuals up to 24 July 2021. Common minor adverse reactions included fever/chills, body aches and injection site pain. These were more common after dose 2. Younger individuals experienced minor adverse reactions more frequently. Rare cases of anaphylaxis, Bell’s palsy and myocarditis/pericarditis were observed. No deaths occurred. Conclusion: Minor adverse reactions were less common than reported in other studies, and rates of anaphylaxis, Bell’s palsy and myocarditis/pericarditis were comparable. Our study supports the favourable safety profile of mRNA COVID-19 vaccines, which may help guide decisions about booster doses if required. Keywords: COVID-19, mRNA vaccine, public health, vaccine, vaccine safety
Background Phosphatase of regenerating liver-3 (PRL-3) is involved in cellular processes driving metastasis, cell proliferation, invasion, motility and survival. It has been shown to be upregulated and overexpressed in cancer tissue, in contrast to low or no expression in most normal tissue. PRL3-zumab is a first-in-class humanized antibody that specifically binds to PRL-3 oncotarget with high affinity and has been shown to reduce tumor growth and increase survival. Objective In the study, we aimed to determine the safety and efficacy of PRL3-zumab in patients with advanced solid tumors and hematological malignancies. Methods We conducted a phase I, first-in-human study in advanced solid tumors and hematological malignancies to investigate the safety, tolerability and efficacy of PRL3-zumab. Response rates were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) for solid tumors. For acute myeloid leukemia (AML) patients, bone marrow response criteria based on the European Leukaemia Network (ELN) 2017 guidelines for AML were used. We also explored the pharmacokinetics and pharmacodynamic relationships of PRL3-zumab in patients. This study was registered with ClinicalTrials.gov: NCT03191682. Results In the dose-escalation cohort, 11 patients with advanced solid tumors were enrolled into the study. An additional 12 patients with solid tumors and four patients with AML were enrolled in the dose-expansion cohort. Maximum tolerability was not achieved in this study, as there were no dose-limiting toxicities. Potential treatment-emergent adverse events were grade 1 increased stoma output and fatigue and grade 2 vomiting. Best response observed was stable disease in three solid-tumor patients (11.1%). The pharmacokinetics of PRL3-zumab were dose proportional, consistent with an IgG type monoclonal antibody. Conclusions PRL3-zumab, a first-in-class humanized antibody, was safe and tolerable in solid tumors and hematological malignancies. Key PointsPRL3-zumab is a first-in-class humanized antibody that specifically binds to phosphatase of regenerating liver-3 (PRL-3), an oncotarget that is upregulated and overexpressed in a variety of tumor types and acute myeloid leukemia.
Introduction: Stroke medicine has evolved over time, with changing demographics and improving outcomes. We aimed to evaluate trends in incidence, risk factors, treatment and case fatality of acute ischemic stroke (AIS) in a multiethnic population. Methods: Data was obtained from the Singapore Stroke Registry. 60,325 AIS cases that presented to Singapore’s public hospitals from 2005-16 were studied. Trends were analyzed with Poisson regression, logistic regression and Cox regression. Results: The AIS age-standardized incidence rate has decreased by 11.6% (126.5 to 111.8 per 100,000 person-years from 2005-07 to 2014-16, p < 0.001). This was observed in all gender and ethnic groups except in those younger than 65, which saw a 2.5% increase (51.0 to 52.4 per 100,000 person-years, p = 0.017). In terms of risk factors, hypertension, hyperlipidemia, and atrial fibrillation have increased in prevalence, while history of stroke, ischemic heart disease, diabetes, and smoking have decreased (Figure A). Treatment-wise, thrombolysis utilization rates have increased significantly from 0.8% in 2005-2007 to 6.7% in 2014-2016 (p < 0.001). While atrial fibrillation (AF) has become more prevalent (15.8% to 25.2%, p < 0.001), anticoagulant prescription has not increased by the same magnitude (13.2% to 14.4%, p = 0.014). Case fatality has reduced by 25.6% (8.2% to 6.1%, p < 0.001). Conclusion: In a multi-ethnic population, whilst we found that AIS age-standardized incidence rate has been declining, we demonstrate a temporal trend of changing risk factors. Further research is needed to investigate the causes and implications of these trends, so as to better strategize prevention efforts.
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