戊型肝炎疫苗和乙型肝炎疫苗联合接种的安全性及免疫原性研究

马建新; 刘瑶瑶; 李倩; 葛申; 张政

Abstract

马建新,刘瑶瑶,李倩,葛申,张政.戊型肝炎疫苗和乙型肝炎疫苗联合接种的安全性及免疫原性研究[J].Chinese journal of Epidemiology,2019,40(4):451-456

戊型肝炎疫苗和乙型肝炎疫苗联合接种的安全性及免疫原性研究

Study on the safety and immunogenicity of simultaneous vaccination on both hepatitis E and hepatitis B vaccines

Received:October 23, 2018

DOI：10.3760/cma.j.issn.0254-6450.2019.04.015

KeyWord: 戊型肝炎疫苗乙型肝炎疫苗联合接种安全性免疫原性

English Key Word: Hepatitis E vaccine Hepatitis B vaccine Simultaneous vaccination Safety Immunogenicity

FundProject:北京市朝阳区艾滋病和病毒性肝炎等重大传染病综合防治示范区建设研究（2018ZX10715005）临床试验注册：Clinicaltrials.gov，NCT02584543

Author Name	Affiliation	E-mail
Ma Jianxin	Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China
Liu Yaoyao	Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China
Li Qian	Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China
Ge Shen	Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China
Zhang Zheng	Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China	zhangzheng@cycdpc.org

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Abstract:

目的分析戊型肝炎（戊肝）疫苗和乙型肝炎（乙肝）疫苗联合接种（联合接种）的安全性及免疫原性。方法 2015年9月至2016年12月在北京市朝阳区招募18~60岁健康受试者720人，将符合纳入标准的受试者随机化分为3组：联合接种（联合接种）组、乙肝疫苗接种组和戊肝疫苗接种组。3组均按照0、1、6个月程序接种，比较联合接种与单独接种的安全性及全程免疫1个月后的免疫原性。结果接种疫苗的受试者共601人（戊肝疫苗接种组150人，乙肝疫苗接种组159人，联合接种组292人）。联合接种组的局部不良反应有疼痛（25.0%，73/292）、红（12.7%，37/292）、瘙痒（9.2%，27/292）、硬结（8.9%，26/292）、肿（8.2%，24/292），全身不良反应有发热（7.2%，21/292）、头痛（5.8%，17/292）、肌肉痛（5.5%，16/292）、疲倦乏力（3.4%，10/292）。联合接种组除局部疼痛发生率高于单独接种组以外，其余不良反应与单独接种组均无明显差异，3组均无严重不良反应。全程接种1个月后，联合接种组的HBsAb阳转率、抗体几何平均浓度（GMC）非劣效于乙肝疫苗接种组（94.2%比93.8%，611.6 WU/ml比745.1 WU/ml），HEV IgG抗体阳转率、GMC非劣效于戊肝疫苗接种组（98.8%比100.0%，11.0 WU/ml比18.0 WU/ml）。结论联合接种具有良好的安全性和免疫原性，建议肝炎易感人群联合接种戊、乙肝疫苗，更好地保护肝脏。

English Abstract:

Objective Safety and immunogenicity regarding simultaneous vaccination on both hepatitis E and hepatitis B vaccines were studied. Methods A total of 600 healthy subjects aged 18-60 were recruited in Chaoyang district of Beijing city, from September 2015 to December 2016. Subjects meeting the inclusion and exclusion criteria were randomly divided into 3 groups:the simultaneous vaccination group of hepatitis E and hepatitis B, the hepatitis B vaccination group and the hepatitis E vaccination group. Members of the 3 groups were all inoculated according to the procedure of ‘0, 1 and 6 months’. Safety and immunogenicity of the simultaneous vaccination group was compared with the individual vaccination groups. Results Vaccination groups had 601 subjects, involved with having 150 subjects of hepatitis E vaccination group, 159 subjects of hepatitis B vaccination group, and 292 subjects of simultaneous vaccination of hepatitis E and hepatitis B. Local adverse reactions that mostly common seen, would include pain (25.0%, 73/292), redness (12.7%, 37/292), pruritus (9.2%, 27/292), callus (8.9%, 26/292), swelling (8.2%, 24/292) at the inoculation sites. Systemic adverse reactions would include fever (7.2%, 21/292), headache (5.8%, 17/292), muscle pain (5.5%, 16/292) and fatigue (3.4%, 10/292). No serious adverse reactions associated with vaccination were seen. In addition to the higher incidence of pain at the inoculation sites, rest of the adverse reactions was similar to the simultaneous vaccination group or the individual vaccination groups. One month after the completed immunization process, positive rate and geometric mean concentration (GMC) of the HBsAb were not inferior to that of the hepatitis B vaccine group (94.2% vs. 93.8%, 611.6 WU/ml vs. 745.1 WU/ml). Positive rate and GMC of the HEV IgG were not inferior to that of the hepatitis E vaccinated group (98.8% vs. 100.0%, 11.0 WU/ml vs. 18.0 WU/ml). Conclusions Simultaneous vaccination strategy on hepatitis E and hepatitis B vaccines showed good safety and immunogenicity. It is recommended that hepatitis E and hepatitis B vaccines should be administered to the susceptible population at the same time, in order to protect the liver functions.

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