12 Months Persistent Immunogenicity after Hepatitis B Vaccination in Patients with Type 2 Diabetes and Immunogenicity of Revaccination in Non-Responders: An Open-Label Randomized Controlled Trial.

Bingfeng Han,Tianshuo Zhao,Shubo Yang,Sihui Zhang,Bei Liu,Wu Liu,Yaqiong Liu,Juan Du,Fuqiang Cui,Shuai Wang,Hanyu Liu

doi:10.3390/vaccines9121407

Abstract

Background: In initial studies, the immunogenicity and safety of hepatitis B vaccines in patients with diabetes has been assessed in China. Methods: In six township health centers in Gansu Province, 232 diabetic patients and 77 healthy people were allocated to receive two 3-dose hepatitis B vaccines (Group D20SC 0-1-6; Group D20CHO 0-1-6; Group ND20SC 0-1-6). Participants were followed up at 12 months after being fully vaccinated. One dose of the vaccine was randomly administered to non-responders. Chi-square test was used to compare the differences in response rate between two groups. Results: The anti-HBs response rates of three groups decreased from 84.1%, 89.1% and 88.3% at one month to 64.6%, 79.8% and 71.4% at twelve months. There was no statistical difference in the immune response rates between Group D20SC 0-1-6 and Group ND20SC 0-1-6; however, that of Group D20CHO 0-1-6 was higher than that of Group D20SC 0-1-6. After revaccination, the geometric mean concentrations were 491.7 mIU/mL and 29.7 mIU/mL after using vaccines containing 60 μg and 20 μg HBsAg. Conclusions: At 12 months, immune response in diabetic patients were not significantly different from that in healthy people. Revaccination with one dose of hepatitis B vaccine containing 60 μg HBsAg for non-responders was more satisfactory.

Highlights

Hepatitis B virus (HBV) infection is a global public health threat with over 296 million people worldwide chronically infected and 820,000 hepatitis B-related deaths in 2019, and there are 1.5 million new infections each year [1]
We identified that the Saccharomyces cerevisiae recombinant and Chinese hamster ovary (CHO) cell recombinant hepatitis B vaccines contained 20 μg
We aimed to examine the 12-month persistent immunogenicity after hepatitis B vaccination in patients with type 2 diabetes and compare the immunogenicity of different revaccinations on non-responders

Summary

Introduction

Hepatitis B virus (HBV) infection is a global public health threat with over 296 million people worldwide chronically infected and 820,000 hepatitis B-related deaths in 2019, and there are 1.5 million new infections each year [1]. In China, the prevalence of HBsAg was 5–6% with about 70 million HBsAg carriers [2], many of which were adults older than 20 years [3,4,5]. Based on a national serosurvey, only 13.8% of adults reported having received a hepatitis B vaccination [6], and many were anti-HBs negatives, indicating there were still many susceptible people of HBV infection. In 2017, hepatitis B vaccination of patients with diabetes was recommended by WHO for the first time [11]. In. In initial studies, the immunogenicity and safety of hepatitis B vaccines in patients with diabetes has been assessed in China. Gansu Province, 232 diabetic patients and 77 healthy people were allocated to receive two 3-dose hepatitis B vaccines (Group D20SC 0-1-6; Group D20CHO 0-1-6; Group ND20SC 0-1-6). Results: The anti-HBs response rates of three groups decreased from

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