Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis

NCT07784452 | Completed

• 1 other identifier: ERB197/02/04-12-2025/AIMC/JHL
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Hepatitis B; ESRD (End Stage Renal Disease); Kidney Failure; Chronic

Keywords

vaccination schedule; Hepatitis B vaccine; Hemodialysis; Immunization response

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Seroprotection (Anti-HBs Titer ≥10 mIU/mL)

  Seroprotection will be assessed by measuring serum Hepatitis B surface antibody (Anti-HBs) titers using a quantitative chemiluminescence immunoassay. A titer of ≥10 mIU/mL will be defined as seroprotection. The proportion of participants achieving seroprotection will be compared between the 3-dose and 4-dose vaccination schedule groups.

  30 days after completion of the assigned vaccination schedule (Month 7 for 3-dose group; Month 7 for 4-dose group)

Study Arms (2)

3-Dose Vaccination Group

ACTIVE COMPARATOR

Participants in this arm will receive 40 mcg recombinant hepatitis B vaccine administered intramuscularly (deltoid muscle of the arm without AV fistula) at 0, 1, and 6 months. Anti-HBs antibody titers will be measured 30 days after completion of the schedule to assess seroprotection.

Biological: Recombinant Hepatitis B Vaccine - 3-Dose Schedule

4-Dose Vaccination Group

ACTIVE COMPARATOR

Participants in this arm will receive 40 mcg recombinant hepatitis B vaccine administered intramuscularly (deltoid muscle of the arm without AV fistula) at 0, 1, 2, and 6 months. Anti-HBs antibody titers will be measured 30 days after completion of the schedule to assess seroprotection.

Biological: Recombinant Hepatitis B Vaccine - 4-Dose Schedule

Interventions

Recombinant Hepatitis B Vaccine - 3-Dose Schedule BIOLOGICAL

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.

3-Dose Vaccination Group

Recombinant Hepatitis B Vaccine - 4-Dose Schedule BIOLOGICAL

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.

4-Dose Vaccination Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on MHD (as per operational definition).
• Anti-HBs antibody titers \<10 mIU/mL irrespective of their prior vaccination status.
• Aged 20-65 years.
• Both male and female.

You may not qualify if:

• Patients with history of active Hep B infection or chronic hepatitis B (positive HBsAg or Hep B Virus DNA).
• Patients with known hypersensitivity to the hepatitis B vaccine or any components of the vaccine.
• Patients with chronic liver diseases (cirrhosis, determined on USG).
• Immunocompromised patients i.e. HIV/AIDS, active malignancy and patients on immunosuppressants therapy.

Sponsors & Collaborators

• Jinnah Hospital: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54700, Pakistan

Location

MeSH Terms

Conditions

Hepatitis B; Renal Insufficiency, Chronic; Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Interventions

Hepatitis B Vaccines; Appointments and Schedules

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Nephrology

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: December 10, 2025
• Primary Completion: July 20, 2026
• Study Completion: August 10, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)