An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool

BackgroundLicensed vaccines are urgently needed for emerging infectious diseases, but the nature of these epidemics causes challenges for the design of phase III trials to evaluate vaccine efficacy. Designing and executing rigorous, fast, and ethical, vaccine efficacy trials is difficult, and the decisions and limitations in the design of these trials encompass epidemiological, logistical, regulatory, statistical, and ethical dimensions.ResultsTrial design decisions are complex and interrelated, but current guidance documents do not lend themselves to efficient decision-making. We created InterVax-Tool (http://vaxeval.com), an online, interactive decision-support tool, to help diverse stakeholders navigate the decisions in the design of phase III vaccine trials.InterVax-Tool offers high-level visual and interactive assistance through a set of four decision trees, guiding users through selection of the: (1) Primary Endpoint, (2) Target Population, (3) Randomization Scheme, and, (4) Comparator. We provide guidance on how key considerations – grouped as Epidemiological, Vaccine-related, Infrastructural, or Sociocultural – inform each decision in the trial design process.ConclusionsInterVax-Tool facilitates structured, transparent, and collaborative discussion of trial design, while recording the decision-making process. Users can save and share their decisions, which is useful both for comparing proposed trial designs, and for justifying particular design choices.Here, we describe the goals and features of InterVax-Tool as well as its application to the design of a Zika vaccine efficacy trial.     

Trends in recent waterborne and foodborne disease outbreaks in South Korea, 2015–2019

ObjectivesThis study analyzed trends in foodborne and waterborne diseases in South Korea between 2015 and 2019.MethodsThe data consisted of information on outbreaks of waterborne and foodborne infectious diseases reported through the Korea Centers for Disease Control and Prevention (KCDC) system. We analyzed the trends and epidemiological aspects of outbreaks by month, place of occurrence, and causative pathogens in this observational study.ResultsThe number of outbreaks has steadily increased over the last 5 years, but the number of cases per outbreak has followed a decreasing trend. Incidence at daycare centers and preschools has been steadily increasing over consecutive years.ConclusionThe steady number of patients and decreasing number of cases per outbreak, even as the number of outbreaks has been increasing, suggest that the KCDC’s professional management system is operating effectively. It is necessary to continue improving the objectivity and efficiency of the management system and to carefully examine the increasing number of outbreaks in smaller-scale group catering facilities, such as daycare centers and preschools. Outbreaks can be prevented by closely examining those caused by unidentified pathogens and group outbreaks caused by other diseases, identifying problems, and supplementing the management system.     

广东省2008-2015年诺如病毒感染暴发的危险因素分析

目的 研究2008-2015年广东省诺如病毒感染暴发疫情的危险因素,为诺如病毒感染的预防控制工作提供参考依据。方法 通过"突发公共卫生事件报告管理信息系统"收集2008年1月1日至2015年12月31日广东省报告的诺如病毒感染暴发疫情资料,并进行流行病学分析。采用RT-PCR 方法对2012-2015年73起诺如病毒感染暴发疫情的372份阳性标本进行基因测序亚型分析。结果 2008-2015年广东省共报告96起诺如病毒感染暴发疫情,其中2013-2015年共报告80起（占83.3%,80/96）。暴发地点在学校的占全部疫情的85.4%（82/96）;传播途径为食源性传播占40.6%（39/96）,接触传播占24.0%（23/96）,水源性传播占7.3%（8/96）。基因测序亚型分析显示, 2012-2013年的暴发主要由GⅡ.4/Sydney2012型诺如病毒感染引起（占30.0%,6/20）,2014-2015年的暴发主要由GⅡ.17型诺如病毒感染引起（占62.3%,33/53）。结论 食源性和接触传播及新出现的2种诺如病毒变异株GⅡ.4/Sydney2012变异株和GⅡ.17是引起广东省诺如病毒感染暴发的主要原因。     

中医药防治流行性腮腺炎暴发流行的体会

目的：探讨中医药防治流行性腮腺炎暴发流行的临床疗效与体会。方法：随机选择流行性腮腺炎暴发流行的2个场所分为对照组及观察组,对照组41例患者、213例高危易感人群给予西医西药防治,观察组49例患者、283例高危易感人群给予中医药防治,观察两组疗效及预防效果。结果：两组1个疗程后总有效率均100.00%,观察组治愈率87.76%明显优于对照组的60.98%,观察组治疗后中医症候评分（0.58±0.17）分较对照组（2.17±0.33）分降低更为明显,观察组自开始治疗至发热开始下降、发热完全消退、腮腺肿痛消退1/3、腮腺肿痛完全消退等所需时间均较对照组明显缩短,观察组预防成功率100.00%优于对照组的94.84%,差异均有统计学意义（P〈0.05）。结论：中医药防治流行性腮腺炎暴发流行可预防高危易感人群发病,迅速缓解患者病情,减轻患者痛苦,缩短病程,疗效优异,值得临床推广应用。     

High-dose influenza vaccines for the prevention of hospitalization due to cardiovascular events in older adults in the nursing home: Post-hoc analysis of a cluster-randomized trial

Older adults are at high risk of major acute cardiovascular events (MACE) linked to influenza illness and preventable by influenza vaccination. It is unknown whether high-dose vaccine might incrementally reduce the risk of MACE. We conducted a post-hoc analysis of data collected from a pragmatic cluster randomized study of 823 nursing homes (NH) randomized to standard-dose (SD) or high-dose (HD) influenza vaccine in the 2013–14 season. Adults age 65 year or older who are Medicare-enrolled long-stay residents were included in the analysis. There were no statistically significant differences in hospitalization for MACE, acute coronary syndromes (ACS), stroke or heart failure between the HD and SD arms. However, in the fee-for-service group, participants in the HD arm had significantly decreased risk of hospitalization for respiratory problems, which was not observed in the Medicare Advantage group. High-dose influenza vaccine was not shown to be incrementally protective against MACE relative to standard-dose vaccine.     

Prevalence and predictors of influenza vaccination among residents of long-term care facilities

Influenza is a respiratory illness which results in significant morbidity and mortality, especially in the older population. Older people living in Long-Term Care Facilities (LTCFs) have a significantly higher risk of infection and complications from influenza. Influenza vaccine is considered the best strategy to prevent infection in high-risk populations. In Australia, the Communicable Diseases Network Australia (CNDA) suggests a vaccination coverage rate of 95% in both staff and residents¹. This study aims to measure the vaccination coverage rates for residents in LTCFs and identify predictors of vaccination uptake for these individuals.This study was conducted in nine LTCFs in four sites from March to September 2018. This was done via medical record reviews for residents over 65 years old in these LTCFs, collecting information such as vaccination status, age, gender, ethnicity and occupation. Simple and multivariable logistic regression was used to calculate the Odds Ratio (OR) to determine significant predictors of influenza vaccination uptake.The overall vaccination rate among LTCF residents was 83.6%. Significant predictors of vaccination were LTCF location, ethnicity and previous year vaccination status. Residents in LTCF Site D were less likely to be vaccinated compared to Site A (OR 0.11, 95% CI 0.02–0.61), non-Caucasians were less likely to get vaccinated (OR 0.09, 95% CI 0.01–0.67), and residents who refused the 2017 vaccine were less likely to be vaccinated (OR 0.04, 95% CI 0.01–0.15).Compared with previous Australian studies on LTCF vaccination rates, the overall vaccination rate was high in these LTCFs (83.6% versus 66–84%), but it varied across different sites. Reasons for varying vaccination rates should be explored further – for example, lower rates in non-Caucasians with diverse cultural backgrounds. Better understanding the causes of under-vaccination can help improve vaccination programs in LTCFs.     

浙江省2006-2007年暴发性胃肠炎中诺如病毒的分子流行病学分析

目的 分析浙江省2006-2007年暴发性病毒性胃肠炎中诺如病毒感染的分子流行病学特征.方法 收集监测期间暴发性病毒性胃肠炎疫情患者的粪便标本及相关流行病学资料.采用RT-PCR及荧光定量RT-PCR检测诺如病毒.随机选掸部分阳性标本扩增部分多聚酶区和衣壳蛋白片段,进行序列测定,结合诺如病毒I(GI)、Ⅱ(GⅡ)基因型参考株进行进化分析.结果 诺如病毒感染暴发性胃肠炎共5起,发生时间均集中于9-12月,送检标本63份,诺如病毒检测阳性45份.序列分析结果显示,浙江省诺如病毒序列与诺如病毒GⅡ/4型参考株同源性最高,其中与北京2006年、荷兰2006年诺如病毒GⅡ/4型变异株最为接近,核苷酸同源性分别为99.7%和98.5%～99.0%.诺如病毒与北京、荷兰流行的GⅡ/4型变异株处于同一分支.结论 诺如病毒是浙江省病毒性腹泻暴发疫情的重要病原体,流行时间集中于秋季,其流行株为GⅡ/4型变异病毒株.     

1952-2008年大连市部分肠道传染病暴发疫情资料分析

[目的]充分认识传染病暴发的危害,指导传染病暴发疫情的防治工作。[方法]收集大连市1952～2008年部分肠道传染病暴发疫情资料进行分析。[结果]1952-2008年合计发生部分肠道传染病暴发疫情82起,发病12058例。其中,伤寒与副伤寒19起,发病1606例;细菌性痢疾7起,发病497例;除霍乱、痢疾、伤寒和副伤寒以外的感染性腹泻暴发疫情合计22起,发病7893例;甲型病毒性肝炎34起、发病2062例。发生在农村的49起、发病6487例,发生在城区的33起、发病5571例;水型暴发42起、发病8236例,食物型暴发13起、发病1821例,生活密切接触暴发17起、发病502例;多种因素引起暴发4起、发病1011例,原因不清6起、发病488例;工人（民工）占36．30％,学生占31．83％,农民占16．91％,城镇居民占13．s2％,学龄前儿童占1．29％;其他人群占0．16％。[结论]大连市部分肠道传染病暴发疫情的主要原因为供水系统污染所致。     

甘肃省临泽县1起校园流行性腮腺炎爆发调查

目的分析流行性腮腺炎的流行情况及综合处理对策。方法对临泽一中106名发病学生进行流行性腮腺炎发病及预防接种情况等的流行病学调查。结果本次爆发共发病106人，具有明显的传染源和传染途径。结论流行性腮腺炎应以预防为主，加强农村的卫生宣传教育工作，重点关注易感人群，积极接种疫苗。