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Prospective study about immunization of attenuated live vaccines in children receiving immunosuppressants

Prospective study about immunization of attenuated live vaccines in children receiving immunosuppressants - Study about live vaccines in children receiving immunosuppressants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007710
Enrollment
200
Registered
2012-04-13
Start date
2012-05-01
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

Patients under treatment of immunosuppressants (CsA, FK, MZR, NNF, AZP)

Interventions

Sponsors

Department of Nephrology and Rheumatology National Center for Child Health and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Equal or more than one years old. 2. Patients under treatment of immunosuppressants (CsA, FK, MZR, MMF, AZP, MTX) 3. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps. 4. Patients who cannot discontinue immunosuppressants because of primary disease. 5. Inactive primary disease. 6. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6). 7. Serum IgG level>300mg/dl 8. FK trough level<10ng/ml or CsA trough level<100ng/ml. 9. Approved by the committee for attenuated live vaccination in children receiving immunosuppressants.

Exclusion criteria

Exclusion criteria: 1. Steroid use of more than 1mg/kg/d. 2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.

Design outcomes

Primary

MeasureTime frame
1) Analysis of antibody acquisition after vaccination classified by each virus. 2) Analysis of maintenance of acquired immunity classified by each virus especially after 1 year. 3) Analysis of incididence of adverse events classified by each virus.

Secondary

MeasureTime frame
1) Analysis of causes of vaccine failure. 2) Analysis of causes of adverse events. 3) Analysis of effect for prevention of virus infection.

Countries

Japan

Contacts

Public ContactKoichi Kamei

National Center for Child Health and Development Nephrology and Rheumatology

kamei-k@ncchd.go.jp+81-3-5494-7128

Outcome results

None listed

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