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NCT07784452 · ClinicalTrials.gov record · last posted 2026-08-25

Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis

Study acronym: 3v4-HEP-DOSE
StatusCompleted
PhaseNot applicable
Started2025-12-10
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from the ClinicalTrials.gov record
People with kidney failure who are on dialysis have a weaker immune response to the hepatitis B vaccine than healthy people. Even after vaccination, many dialysis patients do not develop enough protection against hepatitis B infection. Doctors do not agree on whether giving 3 doses or 4 doses of the vaccine works better for these patients. This study will compare two vaccination schedules using a stronger (double) dose of the hepatitis B vaccine in people on maintenance hemodialysis: Group 1 will receive 3 doses of the vaccine, given at the start of the study, 1 month later, and 6 months later. Group 2 will receive 4 doses of the vaccine, given at the start of the study, 1 month later, 2 months later, and 6 months later. One month after finishing their vaccine schedule, participants will have a blood test to check their antibody levels against hepatitis B. A blood level of 10 mIU/mL or higher will be considered evidence of protection (called seroprotection). The study will compare how many people in each group reach this protective level. The goal of this study is to find out which vaccination schedule (3 doses or 4 doses) gives better protection against hepatitis B in people on dialysis. The results may help doctors choose more effective vaccination strategies for dialysis patients in the future.
Trial Details
NCT Number NCT07784452
Lead Sponsor Jinnah Hospital
Conditions Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure, Chronic
Enrollment 104 participants
Start Date 2025-12-10
Primary Completion 2026-07-20 (estimated)
Study Completion 2026-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-25