Hepatitis B3v4-HEP-DOSENCT07784452
Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis
A study testing Recombinant Hepatitis B Vaccine - 3-Dose Schedule and Recombinant Hepatitis B Vaccine - 4-Dose Schedule in people with Hepatitis B and ESRD (End Stage Renal Disease), run by Jinnah Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure
- What is being tested?
- Recombinant Hepatitis B Vaccine - 3-Dose Schedule and Recombinant Hepatitis B Vaccine - 4-Dose Schedule
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2025to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure, Chronic
- Being tested
- Recombinant Hepatitis B Vaccine - 3-Dose Schedule, Recombinant Hepatitis B Vaccine - 4-Dose Schedule
- Keywords
- vaccination schedule, Hepatitis B vaccine, Hemodialysis, Immunization response
- Medical subject headings
- Hepatitis B, Renal Insufficiency, Chronic, Renal Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hepatitis B Vaccine - 3-Dose ScheduleBiological
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 ScheduleBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Recombinant Hepatitis B Vaccine - 4-Dose Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after completion of the assigned vaccination schedule (Month 7 for 3-dose group; Month 7 for 4-dose group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start10 Dec 2025
- Primary completion20 Jul 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Javed, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784452
- Sponsor's protocol ID
- ERB197/02/04-12-2025/AIMC/JHL
- Acronym
- 3v4-HEP-DOSE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EFFICACY OF TWO IMMUNIZATION SCHEDULES (3 VS 4 DOSES) WITH RECOMBINANT HEP B VACCINE IN PATIENTS ON MAINTENANCE HEMODIALYSIS (MHD)
- ClinicalTrials.gov ID
- NCT07784452
- Acronym / sponsor ID
- 3v4-HEP-DOSE / ERB197/02/04-12-2025/AIMC/JHL
- Conditions
- Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure, Chronic
- Keywords
- vaccination schedule, Hepatitis B vaccine, Hemodialysis, Immunization response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Jinnah HospitalUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Dose Vaccination Group | Active comparator | Biological: Recombinant Hepatitis B Vaccine - 3-Dose ScheduleParticipants 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. |
| 4-Dose Vaccination Group | Active comparator | Biological: Recombinant Hepatitis B Vaccine - 4-Dose ScheduleParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Hepatitis B Vaccine - 3-Dose Schedule40 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 | 3-Dose Vaccination Group |
| Recombinant Hepatitis B Vaccine - 4-Dose Schedule40 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. | Biological | 4-Dose Vaccination Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Hepatitis B Vaccine - 3-Dose Schedule and Recombinant Hepatitis B Vaccine - 4-Dose Schedule in people with Hepatitis B and ESRD (End Stage Renal Disease), run by Jinnah Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.