Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis (3v4-HEP-DOSE)

August 20, 2026 updated by: Bushra Javed, Jinnah Hospital

COMPARISON OF EFFICACY OF TWO IMMUNIZATION SCHEDULES (3 VS 4 DOSES) WITH RECOMBINANT HEP B VACCINE IN PATIENTS ON MAINTENANCE HEMODIALYSIS (MHD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hepatitis B virus (HBV) infection remains a significant concern in hemodialysis units due to repeated vascular access, blood exposure, and the shared dialysis environment. While routine screening, infection control practices, and vaccination programs have reduced HBV transmission in dialysis settings, patients with end-stage renal disease (ESRD) mount a markedly blunted immune response to hepatitis B vaccination compared to the general population. Whereas over 90% of healthy individuals achieve protective antibody levels after standard vaccination, only 50-85% of dialysis patients reach seroprotection, even when higher vaccine doses are used. This immune hyporesponsiveness has been attributed to uremia-associated defects in antigen presentation, T-cell function, and B-cell antibody production.

Several strategies have been investigated to improve seroconversion rates in this population, including increased antigen dose, additional booster doses, intradermal administration, and adjuvanted vaccines. Among these, modifying the number of doses in the immunization schedule (commonly 3-dose vs. 4-dose regimens) has shown inconsistent results across studies. Some trials report significantly higher seroprotection with a 4-dose schedule compared to 3 doses, while others report no statistically significant difference between the two approaches. This inconsistency, combined with a lack of locally generated data from Pakistani dialysis populations, has created uncertainty for clinicians in selecting the optimal immunization strategy for hemodialysis patients.

This randomized controlled trial is designed to directly compare a 3-dose and a 4-dose schedule of double-dose (40 mcg) recombinant hepatitis B vaccine administered intramuscularly to patients undergoing maintenance hemodialysis. Randomization will be performed using the lottery method to allocate eligible participants into one of the two vaccination groups. Both groups will receive the same 40 mcg antigen dose per injection; the schedules differ only in timing and number of doses (0, 1, and 6 months for the 3-dose group vs. 0, 1, 2, and 6 months for the 4-dose group).

At baseline, demographic and clinical data will be collected, including age, gender, body mass index, and duration on maintenance hemodialysis, along with relevant comorbidities (diabetes mellitus, hypertension, and ischemic heart disease), as these factors are known to influence vaccine immunogenicity in dialysis populations. Anti-HBs antibody titers will be measured 30 days after completion of the assigned vaccination schedule using a quantitative chemiluminescence immunoassay. Seroprotection will be defined as an Anti-HBs titer ≥10 mIU/mL. Participants who do not achieve this threshold will be offered an additional vaccine dose as part of routine clinical care.

Post-hoc stratified analysis will be performed by age, gender, BMI, and duration on hemodialysis to evaluate whether these variables modify the relationship between vaccination schedule and seroprotection. Findings from this trial are intended to generate the first local evidence from a Pakistani dialysis cohort on the comparative efficacy of these two immunization schedules, with the aim of informing more effective, evidence-based hepatitis B vaccination protocols in hemodialysis units.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54700
        • Jinnah Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 3-Dose Vaccination Group
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
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.
Active Comparator: 4-Dose Vaccination Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Seroprotection (Anti-HBs Titer ≥10 mIU/mL)
Time Frame: 30 days after completion of the assigned vaccination schedule (Month 7 for 3-dose group; Month 7 for 4-dose group)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinnah Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERB197/02/04-12-2025/AIMC/JHL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside the research team. This is a single-center study conducted without an established institutional data-sharing infrastructure or agreement. De-identified aggregate results will be made available through publication in a peer-reviewed journal and/or presentation at academic forums.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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