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Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis

NCT07784452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

Sponsors & Collaborators

  • Jinnah Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-07-20
Completion
2026-08-10

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784452 on ClinicalTrials.gov