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Hum Vaccin Immunother:甲肝疫苗Healive®和Havrix®在儿童中的免疫原性的持续性:11年随访观察结果

2021-06-28 MedSci原创 MedSci原创

在中国,甲肝疫苗已被用于大规模和常规的公共疫苗接种项目。需要进行长期的跟踪研究,以确定保护的持续时间和加强接种的必要性。研究人员进行了一项前瞻性、随机、开放标签的临床试验,比较了Healive和Hav

在中国,甲肝疫苗已被用于大规模和常规的公共疫苗接种项目。需要进行长期的跟踪研究,以确定保护的持续时间和加强接种的必要性。研究人员进行了一项前瞻性、随机、开放标签的临床试验,比较了Healive和Havrix这两种灭活疫苗所激发的抗甲肝病毒(HAV)抗体的几何平均浓度(GMC)和血清保护率,研究结果已发表于Hum Vaccin Immunother。

400名健康儿童被以3:1的比例随机分配到0和6个月时接受两剂Healive或Havrix。目前的研究报告了免疫后11年的新数据,以显示抗体的持久性。进行了敏感性分析以评估结果。此外,还使用一个统计模型对长期抗体的持续性进行了预测。使用了两种不同的血清学检测方法,显示其在检测anit-HAV抗体方面具有98.3%的一致性。

 

结果显示,与Havrix相比,Healive在接种后1、6、7、66、112和138个月的GMCs明显更高。此外,使用敏感性分析得到的GMCs与使用原始模型得到的GMCs非常相似。预测分析表明,两种疫苗的保护期在免疫后至少为30年,GMC的95%置信区间的下限大于20mIU/ml。

综上,在完全免疫后11年的儿童中,Healive的免疫原性比Havrix更强。预测分析表明,两种疫苗的抗体持续时间至少为30年。

 

原始出处:

 

Yongji Wang, et al., Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction. Hum Vaccin Immunother. 2020 Oct 2;16(10):2559-2564. doi: 10.1080/21645515.2020.1715687.  

 

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    2021-06-30 yige2007

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我国生产的甲肝疫苗和甲肝疫苗通过世界卫生组织预认证

由我国生产的双价口服脊髓灰质炎疫苗(bOPV)和甲肝疫苗(HAV)日前通过世界卫生组织预认证。联合国采购机构现在能采购这两种疫苗用于其他国家的疾病预防和控制。

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