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Extra vaccine dose: could it shield dialysis patients from hepatitis b?

NCT ID NCT07784452

Prevention Sponsor: Jinnah Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial asks whether giving dialysis patients four doses of a double-strength hepatitis B vaccine offers better protection than the standard three doses. People with kidney failure on dialysis often respond weakly to vaccines, leaving many unprotected. The study will compare antibody levels in two groups—one receiving three doses and the other four—to see which schedule helps more patients reach a protective threshold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant hepatitis B vaccine (double-dose)
What this could lead to
If successful, this could identify the best vaccination schedule to protect dialysis patients from hepatitis B, potentially reducing infection rates in this vulnerable group.
What could go wrong
This is a small, early-stage trial, and results may not apply to all dialysis patients. Some people may still not develop protective antibodies even with extra doses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

104 people

The number who actually took part.

Started

Dec 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic renal failure syndrome end stage renal failure kidney failure hepatitis B virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic ESRD (end-stage renal disease) Hepatitis B Kidney failure

Contacts and locations

Locations

  • Jinnah Hospital Lahore

    Lahore, Punjab Province, 54700, Pakistan

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