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Patients with chronic kidney disease (CKD) have immunological defects that result in reduced production and faster decay of anti-HBs after hepatitis B vaccination. We assessed the duration of the immunogenicity after four-standard-dose and four-triple-dose regimens among patients with CKD. A randomized controlled trial was conducted between May 2019 and February 2020. Patients were randomly allocated to receive three or four doses of 20 µg , or four doses of 60 µg of hepatitis B vaccine. Immunogenicity was assessed for 18 months till February 2021. Between months 7 and 18, the seroconversion rate decreased from 81.7% (58/71) to 64.3% (36/56) in IM20 × 3 group, from 93.0% (66/71) to 77.4% (41/53) in IM20 × 4 group, and from 93.2% (68/73) to 90.7% (49/54) in IM60 × 4 group. Seroconversion was higher in IM60 × 4 group than in IM20 × 3 group at month 18 (P < 0.05). In multivariate analysis, CKD patients without immune suppression or hormone therapy or patients with IM60 × 4 were more likely to have durable immunogenicity at month 18. Patients receiving four-triple-dose regimen of hepatitis B vaccine showed improved duration of immunogenicity at the one-year follow-up. ClinicalTrials.gov (NCT03962881). [ABSTRACT FROM AUTHOR]

We evaluated the safety and immunogenicity of four doses of 20 or 60 µg, and the immunogenicity and compliance of the short-term vaccination regimen (0, 1, and 2 months) among patients receiving MMT. We conducted a randomized controlled trial among 303 patients receiving MMT who were randomized to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine. At month 7, the seroconversion rates in both IM20 × 4 and IM60 × 4 groups were numerically higher than the IM20 × 3 group (P > 0.05). The high-level responses and geometric mean concentration (GMC) of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than the IM20 × 3 group (P < 0.05). The completion rate of the short-term high-strength vaccination group was significantly higher than the standard vaccination group (P < 0.05), with similar immunogenicity (P > 0.05). Both the high-strength and standard-strength four-dose hepatitis B vaccine regimens could improve the immune response for patients receiving MMT. The high-strength short-term vaccination regimen could improve compliance and attain comparable immunogenicity with the standard vaccination regimen. The high-strength short-term vaccination regimen is recommended and the fourth dose is encouraged for this population considering the compliance and immunogenicity. ClinicalTrials.gov (NCT03962816) [ABSTRACT FROM AUTHOR]

Background: The immunogenicity against hepatitis B vaccine is unsatisfactory in the chronic kidney disease (CKD) patients, and studies evaluating augmented vaccine regimens to enhance immunogenicity have been inconclusive. Objectives: To evaluate the immunogenicity and safety of four-standard-dose and four-triple-dose regimens hepatitis B vaccine among CKD patients in China. Research design and methods: We conducted a multicenter, randomized, parallel-controlled trial including 273 patients with CKD who were randomly allocated to receive 3 or 4 doses of 20 or 60 µg of recombinant hepatitis B vaccine. Main outcome measures: Seroconversion rates, high-level response rates, and geometric mean concentrations (GMCs) of anti-HBs at months 3 and 7. Results: The seroconversion rates and high-level responses in the IM20 × 4 group and the IM60 × 4 group were higher than those in the IM20 × 3 group at months 3 and 7 (P < 0.05). The IM60 × 4 group had better immune responses than the IM20 × 4 group at month 3 (P < 0.05); however, no significant difference was noted at month 7 (P > 0.05). Conclusions: Both the four-standard-dose and four-triple-dose regimens improved immune response compared to the three-standard-dose regimen of hepatitis B vaccination in CKD patients, and the additional effect of higher dose was minimal. Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03962881). [ABSTRACT FROM AUTHOR]

• The response rate and high-level response rate of the IM60 group were numerically higher than those of the IM20 group at different follow-up points. • The duration of the vaccine-induced responses with 25% of patients with anti-HBs ≥ 10 mIU/mL were 20 months in the IM60 group, and 9.3 months in the IM20 group. • Patients with CD4 ≥ 350 per µL induced higher response rate than the patients with CD4 < 350 per µL at month 7. • No Serious Adverse Events (SAEs) related to vaccination was reported at each follow-up points. To explore the immunogenicity and persistence of the 60 µg hepatitis B vaccine in adults infected with human immunodeficiency virus (HIV). We conducted a randomised controlled trial for adults infected with HIV. A total of 182 patients were randomly allocated to receive 20 µg (IM20 group) or 60 µg (IM60 group) of recombinant hepatitis B vaccine at months 0, 1, and 6 to assess the immunogenicity and were followed-up from month 7 to 42 to assess long-term immunogenicity. Our data showed that the response rate and geometric mean concentration (GMC) of antibodies to hepatitis B surface antigen (anti-HBs) in the IM60 group at month 7 were higher than those in the IM20 group (P > 0.05). The GMC of anti-HBs among the two groups decreased rapidly during the follow-up period (P > 0.05). Survival analysis showed that 25% of patients with anti-HBs ≥ 10 mIU/mL were 20 months in the IM60 group and 9.3 months in the IM20 group. The three-dose 60 µg hepatitis B vaccine showed partially better immunogenicity and persistence than the three-dose 20 µg vaccine. The trial was registered on clinicaltrials.gov, NCT03316807. [ABSTRACT FROM AUTHOR]

• Anti-HBs concentration dropped quickly during the first year after the primary vaccination. • Hemodialysis patients with hemodialysis duration of five years or more had a high risk of losing immune response. • High-dose hepatitis B vaccination provided a satisfactory long-term durability of immunogenicity in patients with hemodialysis duration of five years or more. • Peak anti-HBs levels after vaccination could lead a long-term persistence of immunogenicity. 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. 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. 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). 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. [ABSTRACT FROM AUTHOR]