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Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation

Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation - FBMTG-VAC2015

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016500
Enrollment
300
Registered
2015-02-25
Start date
2015-02-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recipients of hematopoietic stem cell transplantation

Interventions

We measure titer of antibody against measles, mumps, rubella and VZV before vaccination. Administer live attenuated vaccine if patient&#39
s titer of antibody against virus is not positive. Second dose is administered at 4 - 12 weeks after first dose. Finally we measure titer of antibody of virus that vaccine was administered 8 - 16 week

Sponsors

Fukkuoka Blood and Marrow Transplantation Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing HSCT. 2. Twenty four months have been passed after HSCT. 3. No active chronic GVHD. 4. No immunosuppressive drugs such as tacrolimus, cyclosporine and prednisolone. 5. Three months have been passed after transfusion and six months after IVIG. 6. Patient's value go IVIG is equal or greater than 500 mg/dl. 7. Voluntary written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient who received immunosuppressive medications. 2. History of malignant tumors. 3. Severe uncontrolled psychiatric disorder or illness. 4. Serious concurrent uncontrolled medical disorders (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension and infectious diseases). 5. Pregnant or lactating female. 6. Unwillingness or inability to follow the procedures required in the protocol.

Design outcomes

Primary

MeasureTime frame
Titers of antibody against measles, rubella, mumps and VZV in HSCT patients after vaacination

Secondary

MeasureTime frame
Safety of live attenuated vaccine in HSCT patients

Countries

Japan

Contacts

Public ContactTomohiko Kamimura

Harasanshin General Hospital Department of Hematology

chk96670@hkg.odn.ne.jp092-291-3434

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026