1. Long-term persistent immunogenicity after successful standard and triple-dosed hepatitis B vaccine in hemodialysis patients: A 3-year follow-up study in China
- Author
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Guangming Liu, Shuang Dong, Hongting Liu, Linying Gao, Suping Wang, Jing Shi, Jianmin Wang, Xiaohong Shi, Hongping Guo, Liming Liu, Tian Yao, Yawei Zhang, Lina Wu, Xiaofeng Wu, Jiangtao Zhu, Huilin Zhao, Yongliang Feng, Yuanting Wu, Zhihong Shao, Xiaofeng Liang, and Xiaohui Song
- Subjects
China ,medicine.medical_specialty ,Hepatitis B vaccine ,medicine.medical_treatment ,030231 tropical medicine ,Population ,law.invention ,Persistence (computer science) ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Renal Dialysis ,law ,Internal medicine ,Humans ,Medicine ,Hepatitis B Vaccines ,030212 general & internal medicine ,Hepatitis B Antibodies ,education ,education.field_of_study ,Hepatitis B Surface Antigens ,General Veterinary ,General Immunology and Microbiology ,business.industry ,Immunogenicity ,Public Health, Environmental and Occupational Health ,Hepatitis B ,medicine.disease ,Vaccination ,Infectious Diseases ,Molecular Medicine ,Hemodialysis ,business ,Follow-Up Studies - Abstract
Background Although the efficacy of hepatitis B vaccines among hemodialysis patients has been documented, the long-term persistence of immunogenicity in this population remains largely unknown. We explored the long-term persistence of immunogenicity induced by different hepatitis B vaccine regimens in hemodialysis patients. Methods In initial study, we conducted a randomized, multicenter, double-blind, parallel-controlled trial among hemodialysis patients in 13 hospitals in Shanxi Province, China. A total of 352 hemodialysis patients were allocated to receive 3-dose 20 μg (IM20 group) and 3-dose 60 μg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6. Vaccine-induced immune responses were measured at month 7. In this study, the responders (anti-HBs ≥ 10 mIU/mL) were followed up at months 18, 24, 30, 36 and 42, respectively. We used the generalized log-rank test and generalized estimating equations (GEE) to analyze the long-term durability of responses and the kinetics of anti-HBs levels, respectively. Results A total of 284 patients were involved in the extended follow-up period. The duration of vaccine-induced response with 75% of patients maintained protective antibody were 12 months and 18 months in the IM20 group and IM60 group, respectively (P = 0.291). The long-term persistent immunogenicity induced by 3-dose 60 μg was more satisfactory than that by 3-dose 20 μg hepatitis B vaccine in patients with hemodialysis duration ≥ five years (P = 0.023). The peak anti-HBs levels in 100–1000 mIU/mL or ≥ 1000 mIU/mL were more likely to maintain long-term protective antibody compared to anti-HBs levels in 10–100 mIU/mL (P < 0.05). The kinetic profile was similar between the two groups (P = 0.334). Conclusion High-dose 60 μg hepatitis B vaccine could lead a satisfactory long-term durability of immunogenicity among patients with hemodialysis duration of five years or more. Peak anti-HBs level after vaccination was associated with the long-term persistence of immunogenicity.
- Published
- 2021