ive Attenuated Vaccine in Patients Who are Administered Immunosuppressants: A Prospective Intervention Study

ishimura Kenichi0 个研究点目标入组 80 人开始时间: 2019年11月25日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Primary inclusion criteria
•1. Older than 1 year old
•2. Patients who is administered tacrolimus, cyclosporine, mizoribine, azathioprine, mycophenolate mofetil, methotrexate or anti-human thymocyte immunoglobulin
•*Oral administration only for these immunosuppressant other than anti-human thymocyte immunoglobulin
•3. Stable primary disease or kow-risk of primary disease worsening by the vaccination.
•Secondary inclusion criteria
•1. Negative or trace result of the antibody titer under the site standard for the relevant vaccinations
•2. Normal cellular immunity marker both CD4 count >= 500/mm3 and Stimulation index of PHA >= 101.6 SI = (Control(cpm) + PHA(cpm)) / Control(cpm)
•3. Serum IgG >= 300 mg/d

•Primary exclusion criteria
•1.Primary immunodeficiency
•2.Tacrolims trough value more than 10ng/mL or
•cyclosporin trough value 1O0ng/mL
•3. Prednisolone more than daily 1mg/kg or mor
•e than alternative-day administration 2mg/kg
•*Regardless of kinds of steroids and route of administration
•4. Blood transfusion or biologics administration within 3 months before vaccination
•5. Immunoglobulin administration within 6 months before vaccination
•6. Serious allergic reactions to the vaccinations
•7. Pregnant patients or patients who do not agree
•with contraception during the study period.
•8. Unqualified for the study assessed by investigator

发起方

ishimura Kenichi