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Vaccines (Basel). 2021 Nov 29;9(12). doi: 10.3390/vaccines9121407.

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.

Vaccines

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

Affiliations

  1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
  2. Jingyuan County Center for Disease Control and Prevention, Baiyin 730600, China.
  3. Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing 100191, China.
  4. Department of Infectious Diseases and Clinical Microbiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China.

PMID: 34960153 PMCID: PMC8705985 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.

Keywords: diabetes mellitus; hepatitis B vaccines; persistent immunogenicity; revaccination; vaccination

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