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Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis
Sponsor: Jinnah Hospital
Summary
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.
Official title: COMPARISON OF EFFICACY OF TWO IMMUNIZATION SCHEDULES (3 VS 4 DOSES) WITH RECOMBINANT HEP B VACCINE IN PATIENTS ON MAINTENANCE HEMODIALYSIS (MHD)
Key Details
Gender
All
Age Range
20 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-12-10
Completion Date
2026-08-10
Last Updated
2026-08-25
Healthy Volunteers
No
Interventions
Recombinant Hepatitis B Vaccine - 3-Dose Schedule
40 mcg double-dose recombinant hepatitis B vaccine administered intramuscularly in the deltoid muscle of the arm without an arteriovenous fistula, given at 0, 1, and 6 months. Anti-HBs antibody titers will be measured 30 days after completion of the schedule using a quantitative chemiluminescence immunoassay, with seroprotection defined as a titer ≥10 mIU/mL. Participants not achieving seroprotection will be offered an additional vaccine dose as part of routine care.
Recombinant Hepatitis B Vaccine - 4-Dose Schedule
40 mcg double-dose recombinant hepatitis B vaccine administered intramuscularly in the deltoid muscle of the arm without an arteriovenous fistula, given at 0, 1, 2, and 6 months. Anti-HBs antibody titers will be measured 30 days after completion of the schedule using a quantitative chemiluminescence immunoassay, with seroprotection defined as a titer ≥10 mIU/mL. Participants not achieving seroprotection will be offered an additional vaccine dose as part of routine care.
Locations (1)
Jinnah Hospital Lahore
Lahore, Punjab Province, Pakistan