Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Immunisation of migrants in EU/EEA countries: Policies and practices

In recent years various EU/EEA countries have experienced an influx of migrants from low and middle-income countries. In 2018, the “Vaccine European New Integrated Collaboration Effort (VENICE)” survey group conducted a survey among 30 EU/EEA countries to investigate immunisation policies and practices targeting irregular migrants, refugees and asylum seekers (later called “migrants” in this report). Twenty-nine countries participated in the survey. Twenty-eight countries reported having national policies targeting children/adolescent and adult migrants, however vaccinations offered to adult migrants are limited to specific conditions in seven countries. All the vaccinations included in the National Immunisation Programme (NIP) are offered to children/adolescents in 27/28 countries and to adults in 13/28 countries. In the 15 countries offering only certain vaccinations to adults, priority is given to diphtheria-tetanus, measles-mumps-rubella and polio vaccinations. Information about the vaccines given to child/adolescent migrants is recorded in 22 countries and to adult migrants in 19 countries with a large variation in recording methods found across countries. Individual and aggregated data are reportedly not shared with other centres/institutions in 13 and 15 countries, respectively. Twenty countries reported not collecting data on vaccination uptake among migrants; only three countries have these data at the national level. Procedures to guarantee migrants’ access to vaccinations at the community level are available in 13 countries. In conclusion, although diversified, strategies for migrant vaccination are in place in all countries except for one, and the strategies are generally in line with international recommendations. Efforts are needed to strengthen partnerships and implement initiatives across countries of origin, transit and destination to develop and better share documentation in order to guarantee a completion of vaccination series and to avoid unnecessary re-vaccination. Development of migrant-friendly strategies to facilitate migrants' access to vaccination and collection of vaccination uptake data among migrants is needed to meet existing gaps.     

Subchronic toxicity study of ulvan from Ulva pertusa (Chlorophyta) in Wistar rats

Ulvan extracted from Ulva pertusa (Chlorophyta) is a group of sulfated heteropolysaccharide, for simplicity, the sulfated polysaccharide is referred to as ulvan in this paper. To our knowledge, there is no detailed report investigating the toxicity of ulvan. In this study, the subchronic (6 months) toxicity of varying levels of ulvan extracted from U. pertusa was investigated in Wistar rats after oral administration. ALT, ALB, ALP, WBC, PLT, and liver relative organ weigh of female rats showed significantly difference at 3000 mg/kg body weight per day, compared with control group. On the other hand, TG, T-CHO concentrations of female rats (6 months) were significantly decreased at 600, 1200 and 3000 mg/kg body weight per day. This result proved that ulvan had antihyperlipidemic activity. Beside, ulvan showed anticoagulant activity in this study. Overall, our findings indicated that ulvan had affected specific hematology, serum biochemistry parameters and liver, and had great differences between males and females rats.     

孕20～28周胎儿鼻前皮肤正常值范围的建立

目的：建立中国南方人群孕20～28周胎儿鼻前皮肤（ PT）厚度的正常值范围。方法2013年7月至2014年12月,对参加广州市妇女儿童医疗中心中孕期（孕20～28周）超声结构筛查的胎儿进行PT测量,产后3个月进行随访,剔除胎儿结构异常,妊娠合并症及胎儿出生后明显结构缺陷的病例,建立孕20～28周胎儿PT值正常值曲线模型。结果在440例正常胎儿病例中,孕妇中位年龄28岁（21～42岁）,中位孕周23周（20～28周）,胎儿PT中位值4．0mm（2．9～7．2mm）。随着孕周增加, PT从20周的3．8mm增加到孕28周的5．4mm。统计分析,胎儿PT值与孕周呈线性正相关,线性回归方程：PT＝0．285＋0．17× GA（R2＝0．194,P＝0．000）。结论孕20～28周,胎儿PT随孕周增加而增加,并与孕周呈直线相关。     

Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy,BCG-vaccinated,QuantiFERON®-TB Gold (+) Kenyan adults without evidence of tuberculosis

In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON^®-TB Gold In-Tube test (QFT-G)(−) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(−) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(−) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects.     

女性VDT作业人员个性特征研究

采用华西医科大学劳动卫生学教研室研制的系统化职业心理测量（ＯＰＴ）量表，对成都地区２０８名女性ＶＤＴ作业人员和２３３名对照人员的个性特征进行考察。按标准化ＯＰＴ方法实施测验和统计分析。结果表明ＶＤＴ对女性作业人员人格方面产生一定影响。随着平均每周接触ＶＤＴ作业时间的延长，人格倾向于悲观、情绪被动和保守；随着从事计算机年限的增加，人格倾向于乐观、严谨、传统     

An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children

Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months. Pre-specified criteria for non-inferiority of immunogenicity following co-administration versus separate ACWY-TT and DTaP-HBV-IPV/Hib administration were reached. One month post-vaccination, ≥97.3% of ACWY-TT vaccinees had rSBA titres ≥1:8 (all serogroups). Seroprotection/seropositivity rates against DTaP-HBV-IPV/Hib antigens were ≥98.2%. The safety profile of co-administration was similar to that of DTaP-HBV-IPV/Hib alone. ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.     

Dragon's Blood extract has antithrombotic properties, affecting platelet aggregation functions and anticoagulation activities

Ethnopharmacological relevance

Dragon's Blood from Dracaena cochinchinensis (Lour.) S.C. Chen (Yunnan, China), as a traditional Chinese medicinal herb, was shown to have certain antithrombotic effects. A new preparation process was used to extract effective components from Dragon's Blood. A 95% ethanol extract A (EA) and a precipitate B (PB) fraction were obtained and compared. Reliability of the preparation process was validated by pharmacodynamic experiments.

Materials and methods

A rat/mouse thrombosis and blood stasis model was developed for this study, and EA and PB effects on thrombosis, platelet functions and blood coagulation activities were analyzed.

Results

It was observed that the EA fraction had significantly better inhibitory effects than the PB fraction on thrombosis (p < 0.05), platelet aggregation function (p < 0.01) and anticoagulation activity (p < 0.05-0.01).

Conclusions

The results obtained here showed that EA fraction from Dragon's Blood contained pharmacologically effective compounds with antithrombotic effects, partially improving platelet function and anticoagulation activity.     

ALT AST PT T—BIL联合测定对慢性重症肝炎治疗动态监测

目的：探讨慢性重症肝病患者治疗过程中,谷丙转酶,谷草转酶,总胆红素,凝血酶原时间等指标检测的临床探讨。方法：应用日本东亚仪器公司CA一1500型自动血凝分析仪和日本奥林匹斯AU一2700对102例慢性重症肝病患者凝血酶原时间（PT）,谷丙转酶（ALT）,谷草转转酶（AST）,总胆红素（T—BIL）进行了检测,对照组选自我院体检中心健康体检人员（无心、肝、肾功能异常）42例。结果：在慢性重肝炎患者中这4项测定指标与对照组相比有非常显著差异（P〈0．05）。结论：ALT,AST,PT,T—BIL等4项指标的检测可直接反映肝病轻重、肝功能损害状况、可以从多个角度更客观、准确地反映肝病患者在治疗过程中病程进展及预后评估。