臨床研究等提出・公開システム

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

Live vaccines under TNF-alfa inhibitors

Kamei Koichi

National Center for Child Health and Development

2-10-1, Okura, Setagaya-ku, Tokyo

kamei-k@ncchd.go.jp

Kamei Koichi

National Center for Child Health and Development

2-10-1, Okura, Setagaya-ku, Tokyo

+81-3-5494-7128

kamei-k@ncchd.go.jp

Recruiting

May. 15, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

(1) Age >= 1 year.
(2) Patients using TNF-alfa inhibitors
(3) Negative or borderline antibody (EIA-IgG < 4.0) against either measles, rubella, varicella or mumps
(4) CD4 cells >= 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

(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).

Both

Patients using TNF-alfa inhibitors

Immunization of live attenuated vaccines

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

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

+81-3-3416-0181

May. 01, 2023

No

none