Safety and immunogenicity evaluation of 60μg recombinant hepatitis B vaccine (Saccharomyces Cerecisiae) in population aged 16 and above
10.19485/j.cnki.issn1007-0931.2017.09.002
- VernacularTitle:16岁及以上人群接种60μg重组乙肝疫苗安全性及免疫原性研究
- Author:
Ying ZENG
1
;
Lu-Yue CHEN
;
Zhong-Hua YANG
;
Ting-Ting WANG
;
Xiao-Feng LIANG
;
Fu-Zhen WANG
;
Fu-Qiang CUI
;
Wei-Min DU
;
Zheng-Gang JIANG
;
Jun YAO
Author Information
1. 深圳康泰生物制品股份有限公司
- Keywords:
Recombinant hepatitis B vaccine(Saccharomyces Cerecisiae);
Non-responders;
Safety;
Immunogenicity
- From:
Journal of Preventive Medicine
2017;29(9):869-873
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of 60μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae)in healthy population over 16 years old and immunogenicity in non-responders.Methods A total of 4345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine, including 3415 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 4345 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 %(657/4345)and 4.05%(176/4345)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 60μg 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.
