Comparative immunogenicity of two vaccination schedules of a combined hepatitis A and B vaccine in healthy volunteers

Summary. In 1996, a combined vaccine against both hepatitis A and B was licensed and commercialized and has been recommended for healthcare personnel in Belgium. This study compares the immunogenicity against hepatitis B virus (HBV) and safety of two vaccination schedules (0–1–12 months and 0–1–6 months) with this vaccine. This is a randomized, stratified and controlled study in healthy adult workers, who are not occupationally exposed to HBV. Seroconversion (≥1 IU/L) and seroprotection (≥10 IU/L) rates were compared using Fisher’s exact test; geometric mean concentrations (GMCs) of anti‐HBs were compared using one‐way ANOVA. All statistical analyses were carried out with SPSS 11 on Apple Macintosh. A total of 399 subjects were enrolled in the study, and 356 were analysed according to the protocol. The rate of ≥10 IU/L at 6 months was 70.6% in the group 0–1–12 and 79.9% in the group 0–1–6; this rate decreased to 55.9% at 12 months in the first group. Seroconversion and seroprotective rates against HBV measured at month 13 in group 0–1–12 (98.9% and 95.6%) and measured at month 7 in group 0–1–6 (99.4% and 97.1%) were not statistically significantly different. GMC of anti‐HBs after the 0–1–12 schedule was more than two fold higher than after 0–1–6 schedule (P < 0.001). Reported side effects were comparable in both groups with a slight tendency to fewer side effects in the 0–1–12 group after the third dose. The results from our study show that the completed schedule 0–1–12 offers at least equal protective immunogenicity against HBV as the completed 0–1–6 schedule. People not receiving their third dose at 6 months can be given this dose up to 12 months after the first dose. The drawback of this flexibility, however, is the longer time period before the protection becomes effective.     

2010-2012年云南省昌宁县从业人员HAV和HEV感染情况

目的了解云南省昌宁县食品、公共场所从业人员甲型肝炎病毒（HAV）、戊型肝炎病毒（HEV）携带情况，为制定干预措施提供依据。方法采用酶联免疫吸附试验（ELISA）法对2010--2012年10803例从业人员进行HAV、HEV检测，并对结果进行分析。结果2010--2012年从业人员HAV携带率为0．12％，HEV携带率0．14％。男性HAV携带率为0．20％，女性携带率为0．074％；男HEV携带率为0．074％，女携带率为0．18％。食品从业人员HAV携带率为0．12％，HEV携带率为0．12％；公共场所从业人员HAV携带率为0．14％，HEV携带率为0．20％。HAV在40—49岁年龄组构成比最大，HEV在20～29和30—39岁2个年龄组构成比最大。甲型和戊型病毒性肝炎全年都有发病，但集中分布在5—9月份。结论昌宁县食品、公共场所从业人员HAV、HEV携带率低于全国平均水平；HAV阳性率男性明显高于女性，HEV阳性率女性明显高于男性；公共场所从业人员HAV、HEV阳性率明显高于食品从业人员。做好食品、公共场所从业人员进行1年1次预防性健康检查和上岗前预防性健康检查，是降低昌宁县人群中HAV、HEV感染率的有效干预措施。     

Quantification and duration of viraemia during hepatitis A infection as determined by real-time RT-PCR

Human transmission studies and molecular techniques have provided evidence that transient viraemia occurs during infection with hepatitis A virus (HAV). However, the duration of its presence and levels during the phases of clinical disease and convalescence has not yet been well studied in human patients. Real-time RT-PCR techniques are increasingly used to quantify RNA viruses for diagnosis and/or research purposes. We have optimized a one-step RT-PCR that contains a dual-labelled fluorogenic probe to quantify the 5' noncoding region (5'NCR) of HAV. This method has a dynamic range (5–5 × 10⁶ copies). The coefficient of regression of the standard curve was, on average 0.978. Intra-assay CVs% varied from 6.1% to 0.98%, and interassay CVs% from 6.46% to 2.1%. In the currently reported study 41 HAV IgM positive serum samples and 200 serum samples from healthy blood donors were tested by the quantitative RT-PCR method. The mean values on the first day of diagnosis found was 6.38 × 10⁵ copies/mL. In a longitudinal study, viraemia persisted for an average of 60 days after clinical onset. These results show that viraemia in HAV infection lasts for many weeks.     

普外科急诊手术患者术前感染性指标的临床诊断及分析

目的探讨普外科急诊手术术前感染性指标的临床诊断和意义,以期提高医疗安全性。方法随机选取14380例普外科急诊手术患者,在术前均予以感染性指标乙型肝炎病毒(HBV)、丙型肝炎病毒抗体(抗HCV)、人类免疫缺陷病毒型抗体(抗-HIV)及梅毒螺旋体抗体(TPAb)检测,分析各项临床意义。结果 HBsAg阳性率为15.22%;抗-HCV阳性率为0.68%;抗-HIV阳性率为0.097%;抗-TP阳性率为1.06%。其中HBsAg和抗-TP阳性以20~40岁的男性居多,抗-HIV呈现平稳中升高趋势。结论普外科急诊手术做好感染性指标可探查患者的体质和手术适应证,另外一方面可防止医疗纠纷。     

RNA testing for the diagnosis of acute hepatitis A during the 2017 outbreak in France

Diagnostic of acute hepatitis A virus (HAV) infection is based on the detection of anti‐HAV IgM without testing for the pathogen itself. We evaluated the usefulness of HAV RNA testing for confirmation of acute hepatitis A and to provide indications about the level of HAV replication in HIV‐positive and HIV‐negative subjects during an unprecedented outbreak of HAV observed in France in 2017. HAV RNA was detected in 38 out of 41 (92.6%) subjects with a clinical diagnosis of acute hepatitis A, whereas nine cases tested positive for anti‐HAV IgM in whom the diagnosis of acute hepatitis A was not retained were found negative for HAV RNA. All subjects in the control group were also tested negative for HAV RNA. HAV viremia was correlated to ALT peak (r = .64; P < .0001). HIV‐infected patients have similar HAV RNA levels but were less likely to have prolonged international normalized ratio of prothrombin time when compared to the HIV‐uninfected group (P = .016), suggesting a less severe course of acute hepatitis. HAV RNA was detected in the serum of most of the patients with acute hepatitis A, indicating that the direct detection of HAV can be used to confirm hepatitis A in patients tested positive for anti‐HAV IgM antibodies. Nucleic acid tests should serve more broadly during the diagnosis workup of acute hepatitis A to improve the predictive values of HAV in vitro diagnostic tests and to confirm acute hepatitis A in patients tested positive with IgM with moderate or low S/CO values.     

Hepatitis A, B, C and E virus markers in Chinese residing in Tokyo, Japan

Aim: Recently, the number of foreigners living in Japan has been increasing, with the majority originating from China. It is important for us to know the prevalence of hepatitis virus markers among them, as proper medical practices and vaccinations should be prepared when seeing them and their offspring. Methods: We examined the relationship between the prevalence of hepatitis virus markers: hepatitis B surface antigen (HBsAg), anti-HBs, anti-hepatitis C virus (HCV), anti-hepatitis A virus (HAV) and anti-hepatitis E virus immunoglobulin (Ig)G, and background such as age, birthplace and length of stay in Japan, of 568 Chinese residing in Tokyo, and also of 55 indigenous Japanese. Results: The prevalence of HBV and HAV markers in Chinese staying in Tokyo is higher than in indigenous Japanese (HBsAg, 10% vs 1.8%; anti-HBs, 45% vs 9.0%; anti-HAV, 90% vs 14%). There were no differences in anti-HCV and anti-HEV IgG between the two groups. Conclusion: Indigenous Japanese subjects have less immunity against HAV and HBV. The HBV carrier rate is higher in Chinese subjects, and attention should be paid to this issue in clinical practice. It might be important to control hepatitis viruses in Chinese subjects when doctors see them in Japan.     

血液及血制品感染因子检测

目的 了解1997-1999年度我市临床使用的血液及血液制品中甲肝病毒（HAV）、乙肝病毒（HBV）丙肝病毒（HCV）、艾滋病病毒（HIV）及梅毒螺旋体的感染情况。方法 用ELISA、PCR和TRUST对171份血液、83份血制品检测了抗-HAVIgM,HBsAg，抗-HCV，HCVRNA、抗-HIV1 2、TRUST、TPPA。结果 171份血液标本抗-HAVIgM、抗-HCV、抗-HIV1 2皆阴性；HBsAg阳性1例（0.058%)，酶毒1例（0.058%)；83份血制品杭-HAVIgM、HB，抗-HIV1 2、TRUST均阴性，抗-HCV阳性率为24.1%，均为人血丙种球蛋白，取4个批号阳性的各2份进行HCV-RNA检测。结果6份HCVRNA阳性。结论 1997-1999年度临床上所使用的血液及血制品（人血丙种球蛋白）仍存在残余危险，需采取措施减少残余危险度。     

HAV H2株不同代次减毒活疫苗的免疫应答和接种反应

将132名甲型肝炎易感儿童随机分为3个组。每组44人。第1组儿童接种H_2M_(20)K_16疫苗,第2组接种H_2M_(20)K_7疫苗。全程接种1针,皮下注射,剂量为10~(6·5)TCID_(50)/1ml。第3组为对照组不接种疫苗。两组疫苗接种均安全。免后1～2个月的抗-HAV阳转率均达80％以上。在观察地区发生甲型肝炎流行时,两组疫苗的保护率分别为100.00％和80.02％。说明在甲型肝炎流行季节前接种H_2M_(20)K_(16)或H_2M_(20)K_7疫苗均可达到有效控制甲型肝炎的流行。