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The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study

The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study - The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018627
Enrollment
80
Registered
2015-10-01
Start date
2015-10-01
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

collagen diseases, kidney diseases, digestive diaseases, liver diaseases, neurological diseases, kidney transplant patients

Interventions

Sponsors

Department of Pediatrics, Yokohama City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Equal or more than one years old. 2. Patients under treatment with immunosuppressants(tacrolimus, cyclosporine, mizoribine, azathioprine, methotrexate mycophenolate mofetil) 3. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6). 4. Serum IgG level>300mg/dl 5. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps. 6. Patients under treatment with prednisolone <1mg/kg/day or <2mg/kg every alternate day. 7. tacrolimus trough level<10ng/ml or cyclosporine trough level<100ng/ml. 8. Patients with low activity of underlying disease. 9. Patients who cannot discontinue immunosuppressants because of primary disease.

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) Assessment of antibody acquisition after vaccination classified by each virus. 2) Analysis of long maintenance of acquired immunity. 3) Analysis of incididence of adverse events.

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 ContactKenichi Nishimura

Yokohama City University Department of Pediatrics

k_nsm@yokohama-cu.ac.jp+81-45-787-2671

Outcome results

None listed

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