ClinicalTrials.gg
WithdrawnNCT06888479Updated Nov 12, 2026

Optimal Timing of Hepatitis B Vaccination After Transplants

A Phase 3 interventional study of hepatitis B vaccine in Transplant-Related Disorder, Hepatitis b Virus Infection and Vaccine Reaction, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Withdrawn at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 3, Interventional, and Prevention

Why this study was withdrawn
Insufficient execution and compliance
Updated Nov 12, 2026Now WithdrawnStart date moved+5 moreGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 192 studies in Hepatitis B with a site in China — 39 open to participants now, 49 under way, 1 of them phase 3. Hepatitis B · China.

Enrollment
134th of 136
0 · median 123
Started
2026
with 9 others
Phase 3
10 of 192
1 open now
Registered
167th of 192
by date

Among the 192 studies in Hepatitis B with a site in China, this one is the 134th largest by enrollment of the 136 interventional ones that give a count, is one of 10 that started in 2026, is one of 10 in phase 3, and was the 167th registered.

Hepatitis B

1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

Browse Hepatitis B studies →

Open to participants now

39 of the 192 studies in Hepatitis B with a site in China are open now. Recruiting first, the newest first:

34 more — sign in →

All 39 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.

This study: 16 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.

03

Conditions studied

  • Transplant-Related Disorder
  • Hepatitis b Virus Infection
  • Vaccine Reaction

Browse trials for

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must be ≥ 16 years old;
  2. Patients receiving hematopoietic cell transplantation;
  3. Patients achieving complete molecular remission;
  4. Patients or their guardians have to sign an form before the start of the research procedure.

Exclusion criteria

Exclusion Criteria:

  1. Multiple transplantations;
  2. Donors' or HBsAg are positive;
  3. Patients' HBV-DNA or HBsAg are positive before transplantation or \< 3 months after transplantation;
  4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;
  5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    'Early Vaccination' (low-risk)

    Patients with composite immune risk score (CIRS) ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation.

    Biological: hepatitis B vaccine

  • Experimental
    'Early Vaccination' (high-risk)

    Patients with CIRS \> 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 3, 4, and 9 months after transplantation.

    Biological: hepatitis B vaccine

  • Active comparator
    'Guideline' (low-risk)

    Patients with CIRS ≤ 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.

    Biological: hepatitis B vaccine

  • Active comparator
    'Guideline' (high-risk)

    Patients with CIRS \> 2.5 and being assigned to receive 3 doses of hepatitis B vaccine at 6, 7, and 12 months after transplantation.

    Biological: hepatitis B vaccine

Interventions

  • Biologicalhepatitis B vaccine

    Three doses of hepatitis B vaccine

06

What researchers measure

Primary outcomes

  1. Titer of hepatitis B surface antibodies (HBsAb).

    The investigators will compare the titer of HBsAb one month after the completion of 3 doses of hepatitis B vaccine in transplants with different timing of hepatitis B vaccination, different donor type and different immune reconstitution status.

    Time frame: One month after the completion of 3 doses of hepatitis B vaccine.

Secondary outcomes

  1. HBV infection

    HBV-DNA or HBsAg are positive

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jan 2026 to primary completion in Jan 2026, 0 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: start Jun 2025 → Jan 2026, primary completion Jun 2028 → Jan 2026 and completion Mar 2029 → Jan 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2025
First posted
Mar 21, 2025
StartActual
Jan 1, 2026was Jun 2025
Primary completionActual
Jan 1, 2026was Jun 2028
CompletionActual
Jan 1, 2026was Mar 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Withdrawn Insufficient execution and compliance
changed Nov 12, 2026
Sites
1 site added, 1 site removed
Show site
  • Institute of Hematology & Blood Diseases Hospital · Tianjin, China
Show 1 removed
  • Institute of Hematology & Blood Diseases Hospital · Tianjin, China
Nov 12, 2026
Start date
Jun 1, 2025→Jan 1, 2026 (actual)
Nov 12, 2026
Primary completion
Jun 1, 2028→Jan 1, 2026 (actual)
Nov 12, 2026
Study completion
Mar 1, 2029→Jan 1, 2026 (actual)
Nov 12, 2026
Enrollment
1500 (estimated)→0 (actual)
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Not yet recruiting→Withdrawn
    Why stopped Insufficient execution and compliance
    1 site added, 1 site removed
    Show site
    • Institute of Hematology & Blood Diseases Hospital · Tianjin, China
    Show 1 removed
    • Institute of Hematology & Blood Diseases Hospital · Tianjin, China
    Start date Jun 1, 2025→Jan 1, 2026 (now actual)
    Primary completion Jun 1, 2028→Jan 1, 2026 (now actual)
    Study completion Mar 1, 2029→Jan 1, 2026 (now actual)
    Enrollment 1500 (estimated)→0 (actual)
    + 5 other changes: identifiers, verification date, oversight details, conditions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06888479
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Jan 1, 2026
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026
Last update
Nov 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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