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Live vaccines under TNF-alfa inhibitors

Multicenter prospective study of attenuated live vaccines for patients using TNF-alfa inhibitors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230070
Enrollment
200
Registered
2023-05-15
Start date
2023-05-15
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 using TNF-alfa inhibitors

Interventions

Immunization of live attenuated vaccines

Sponsors

Kamei Koichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age >= 1 year. (2) Patients using TNF-alfa inhibitors (3) Negative or borderline antibody (EIA-IgG = 500/mm3 PHA stimulation index >= 101.6 Serum IgG >= 300mg/dL (5) PSL<=1mg/day or <=2mg/2days (6) Disease activity is stable for more than 6 months

Exclusion criteria

Exclusion criteria: (1) Patients using other biological agents. (2) Patients with hematological disease or after bone marrow transplantation. (3) High disease activity. (4) Patients under immunoglobulin replacement. (5) Patients who are planned to receive inactivated VZV vaccine (they cannot receive live varicella vaccine, but can receive MR and mumps vaccine).

Design outcomes

Primary

MeasureTime frame
Seropositivity rate of measles, rubella, varicella and mumps after MR, varicella and mumps vaccination

Secondary

MeasureTime frame
Seropositivity rate including additional vaccination. Analysis of risk factors for vaccine failure Presence or absence and frequency of breakthrough infection Presence or absence and frequency of vaccine strain infections Analysis of characteristics of cases with vaccine strain infections Other adverse events

Contacts

Public ContactKoichi Kamei

National Center for Child Health and Development

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

Outcome results

None listed

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