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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

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...

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Detalles Bibliográficos
Autores principales: Han, Bingfeng, Liu, Wu, Du, Juan, Liu, Hanyu, Zhao, Tianshuo, Yang, Shubo, Wang, Shuai, Zhang, Sihui, Liu, Bei, Liu, Yaqiong, Cui, Fuqiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8705985/
https://www.ncbi.nlm.nih.gov/pubmed/34960153
http://dx.doi.org/10.3390/vaccines9121407
Descripción
Sumario: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.