|
|
|
| Safety and immunogenicity evaluation of 60 μg recombinant hepatitis B vaccine（Saccharomyces Cerecisiae）in population aged 16 and above |
| ZENG Ying, CHEN Lu-yue, YANG Zhong-hua, WANG Ting-ting, LIANG Xiao-feng, WANG Fu-zhen, CUI Fu-qiang, DU Wei-min, JIANG Zheng-gang, YAO Jun
|
| Shenzhen Kangtai Biological Products Co.,Ltd.,Shenzhen,Guangdong,518057,China |
|
|
|
|
Abstract Objective To evaluate the safety of 60 μg recombinant hepatitis B vaccine（Saccharomyces Cerecisiae）in healthy population over 16 years old and immunogenicity in non-responders. Methods A total of 4 345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine, including 3 415 participants who have never been vaccined before and 930 non-responders. All participants were monitored for any adverse events occurring within 30 min after each injection and instructed to record selected injection-site reactions and systemic reactions on the day of vaccination and the subsequent 28 days. Blood samples were collected from non-responders at pre-vaccination and one month after vaccination,in order to determine anti-HBs levels,positive rates of anti-HBs and the mean geometric titre（GMT）of anti-HBs. Results Among 4 345 vaccinated participants,16.39 % of them reported at least one injection-site or systemic adverse reaction. The most common injection-site and systemic adverse reactions were Grade 1 adverse reactions with the incidence of 15.12 %（657/4 345）and 4.05%（176/4 345）respectively. No serious adverse events were observed. Among 930 non-responders,the positive rate of anti-HBs was 87.03 % with active responder of 76.74 %（551 / 718）and the GMT of anti-HBs was 479.28 mIU / ml. The positive rate of anti-HBs was not associated with gender or age（P>0.05）. The GMT of anti-HBs demonstrated significant differences between female and male （560.66 mIU / mL VS. 404.91 mIU / mL,P<0.05）,but there was no significant differences in different age groups（P>0.05）. Conclusion 60 μg recombinant hepatitis B vaccine was safe for healthy adults above 16 years and had good immunity efficacy among non-responders who had no or low response to standard immunization regimen of hepatitis B vaccine.
|
|
Received: 05 January 2017
Revised: 27 February 2017
Published: 12 October 2017
|
|
|
|
|
|
[1] World Health Organization. Guidelines for the prevention,care and treatment of persons with chronic hepatitis B infection [EB/OL]. http://apps.who.int/medicinedocs/documents/s21813en /s21813en.pdf.
[2] 中华预防医学会,中国疾病预防控制中心免疫规划中心. 中国成人乙型肝炎免疫预防技术指南[J]. 中华流行病学杂志 ,2011 ,32 （12）：1199-1203.
[3] ROUKENS A H ,VISSER L G . Hepatitis B vaccination strategy in vaccine low and non-responders：A matter of quantity of quality?[J]. Human Vaccines ,2011 ,7 （6）：654-657.
[4] 国家食品药品监督管理局. 预防用疫苗临床试验不良反应分级标准指导原则[S]. 2005-10-14.
[5] WANG Z Z,LI M Q,WANG P,et al. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China[J]. Vaccine ,2016 ,34 （8）：1034-1039.
[6] SHOUVAL D,ROGGENDORF H,ROGGENDORF M. Enhanced immune response to hepatitis B vaccination through immunization with a Pre-S1/Pre-S2/S vaccine[J]. Medical Microbiology and Immunology ,2015 ,204（1）：57-68.
[7] DUAN Z J,CHEN X,LIANG Z,et al. Genetic polymorphisms of CXCR5 and CXCL13 are associated with non-responsiveness to the hepatitis B vaccine[J]. Vaccine ,2014,32（41）：5316-5322.
[8] LI Z K,NIE J J,LI J,et al. The effect of HLA on immunological response to hepatitis B vaccine in healthy people：A meta-analysis[J]. Vaccine,2013 ,31 （40）：4355-4361.
[9] FILIPPELLI M ,LIONETTI E ,GENNARO A ,et al. Hepatitis B vaccine by intradermal route in non responder patients：an update[J]. World Journal of Gastroenterology,2014,20 （30）：10383-10394.
[10] SAYAD B ,VAZIRIAN A ,VAZIRI S ,et al. Effects of oral levamisole as an adjuvant to hepatitis B vaccine in health-care workers non-responders to previous vaccinations：A randomised controlled trial[J]. Journal of Clinical Virology ,2015 （69）：241-242.
[11] 宋红潮,熊传庆,梁绍莲,等. 两种大剂量乙型肝炎疫苗对低/无应答成人再免疫效果分析[J]. 中国热带医学,2016,16（1）：60-62.
[12] 彭友杏,苏永红. 60 μg乙型肝炎疫苗对无应答人群免疫效果观察[J].中国美容医学,2012 ,21 （12）：217-218.
[13] 陈胜玉,余运贤,王学才,等. 成人乙型肝炎疫苗免疫无应答影响因素及60μg重组疫苗复种效果评价[J]. 预防医学,2016 ,28 （8）：762-765.
[14] PAN H X ,ZENG Y ,SONG X F ,et al. Immune response to hepatitis B vaccine with high antigen content in non-responders after standard primary vaccination in Chinese adults[J]. Vaccine ,2014 ,32 （29）：3706-3712.
[15] 郭敏建,姚军,李静. 成人乙肝疫苗不同免疫程序效果观察[J]. 浙江预防医学,2015,27（8）：757-760.
[16] YANG L N ,YAO J ,LI J ,et al. Suitable hepatitis B vaccine for adult immunization in China[J]. Immunologic research,2016 ,64 （1）：242-250.
[17] 孙迎春,朱丽君,张智,等,不同人群接种重组（汉逊酵母）乙肝疫苗后免疫效果观察[J].吉林医学,2012,33 （16）：3395-3396.
[18] WANG H ,CAI B Y ,RAO D L,et al. Rapid immunization effects of a new type of 60 μg hepatitis B vaccine compared with traditional 20 μg hepatitis B vaccines in adults[J]. Human vaccines & immunotherapeutics,2016,12（11）： |
|
|
|
