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Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents

Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents - Multcenter study of attenuated live vaccines

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035404
Enrollment
2000
Registered
2018-12-30
Start date
2019-03-01
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 steroid or immunosuppressive agents

Interventions

Immunization of live attenuated vaccine

Sponsors

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 one or more of steroid (PSL, mPSL) or immunosuppressants (Tac, CsA, MZR, AZP, MMF, EVR, MTX, 6-MP, sirolimus) 3. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps. 4. Immunological parameters are as follows 1) CD4 counts>500/mm3 2) PHA lymphocyte stimulatory test-stimulation index>101.6 3) Serum IgG level>300mg/dl 5. Patients who had the history of rituximab treatment should show CD+B cells of more than 1%. 6. Steroid treatment has to be under 1mg/kg/d or 2mg/kg/2d of PSL 7. Inactive primary disease.

Exclusion criteria

Exclusion criteria: 1) Patients under biological agents. 2) Patients under active primary disease. 3) Patients who are considered inappropriate for immunization of live attenuated vaccines according to the attached documents. 4) Patients who do not agree the study entry. 5) Patients who are considered inappropriate for immunization according to the physician in charge.

Design outcomes

Primary

MeasureTime frame
Analysis of seropositivity rates of measles, rubella, varicella and mumps after vaccination of MR vaccine, measles vaccine, rubella vaccine, varicella vaccine and mumps vaccine.

Secondary

MeasureTime frame
1) Comparison of antibodies between before and after vaccination of each virus. 2) Analysis of risk factors of vaccine failure. 3) Adverse events 4) Immunological analysis of cases who suffered from vaccine-strain infection after vaccination.

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