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Varicella vaccine for patients using TNF-alfa inhibitors

Varicella vaccine for patients using TNF-alfa inhibitors

10

Patients with rheumatoid disease or inframmatory bowel disease who are under TNF inhibitors. Median age was 9.5 years old (4-17 years old) and boys were two. Juvenile idiopathic arthritis was five and inflammatory bowel disease was five. Seven patients were using adalimumab and three were using infliximab.

We conducted the prospective study of varicella live vaccine in 10 patients with rheumatoid disease or inframmatory bowel disease who are under TNF-alpha inhibitors. All 10 patients continued study observation and none discontinued during study period.

Vaccine strain varicella was not observed. All adverse events were not related to varicella vaccine. One severe adverse event (COVID-19) was observed, although it was not related to varicella vaccine, neither.

Primary Outcome : Presence or absence of vaccine strain varicella Result of primary outcome : Ten patients were vaccinated 13 times. Vaccine strain varicella was not observed. Secondary Outcomes : 1. Seropositivity rate after varicella vaccination 2. Other adverse events Result of secondary Outcomes : 1. Five of 10 patients were seroconverted. Included the additional vaccines, six of ten patients were seroconverted. 2. One severe adverse event was observed (COVID-19). Other adverse events were not related with varicella vaccines.

We conducted prospective study of varicella live vaccines for patients with TNF-alpha inhibitors. Ten patients (juvenile idiopathic arthritis, 5; inflammatory bowel disease, 5) were enrolled. Seven were using adalimumab and three were using infliximab. Five of ten (50%) were seroconverted after the single dose of varicella vaccination. Including additional shots, six patients (60%) were finally seroconverted. Vaccine-related varicella was not observed.

Nov. 08, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031210428

Kamei Koichi

Division of Nephrology and Rheumatology, National Center for Child Health and Development

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

kamei-k@ncchd.go.jp

Kamei Koichi

Division of Nephrology and Rheumatology, National Center for Child Health and Development

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

+81-3-5494-7128

kamei-k@ncchd.go.jp

Complete

Nov. 16, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Age > 1 year.
(2) Patients using TNF-alfa inhibitors
(3) Negative or borderline varicella antibody (EIA-IgG < 4.0)
(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 of hematological disease or after bone marrow transplantation.
(3) High disease activity.
(4) Patients under immunoglobulin replacement.

Both

Patients using TNF-alfa inhibitors

Immunization of varicella vaccine

Presence or absence of vaccine strain varicella

Seropositivity rate after varicella vaccination
Other adverse events

+81-3-3416-0181

Oct. 29, 2021

none