NCT07784452Completed
Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis
COMPARISON OF EFFICACY OF TWO IMMUNIZATION SCHEDULES (3 VS 4 DOSES) WITH RECOMBINANT HEP B VACCINE IN PATIENTS ON MAINTENANCE HEMODIALYSIS (MHD)
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 20 Aug 2026
- Start date
- 10 Dec 2025
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- Jinnah Hospital
- Diseases
- Hepatitis B, Chronic kidney disease
- NCT number
- NCT07784452
What you commit to
- Study type: Interventional
- Participants enrolled: 104
- From 10 Dec 2025 to the primary completion date, 20 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jinnah Hospital Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.