Varicella vaccine for patients using TNF-alfa inhibitors

JRCT ID: jRCTs031210428

Registered date:16/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients using TNF-alfa inhibitors
• Date of first enrollment: 16/11/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Immunization of varicella vaccine

Outcome(s)

• Primary Outcome: Presence or absence of vaccine strain varicella

Secondary Outcome

Seropositivity rate after varicella vaccination
Other adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Kamei Koichi
• Source(s) of Monetary Support: A grant from the National Center for Child Health and Development (2021B-9),Public Foundation of Vaccination Research Center