Study of Live Attenuated Vaccine in Immunosuppressed Patients
- Conditions
- Immunosuppressed patients
- Registration Number
- JPRN-jRCTs031190140
- Lead Sponsor
- ishimura Kenichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Positive rate of each viral IgG 2-6 months after vaccination<br>Safety: Content and frequency of severe adverse events
- Secondary Outcome Measures
Name Time Method Efficacy: Positive rate (retention ratio) of each viral IgG antibody titer 1 year after vaccination, Changes of each antibody titer before, 2 to 6-month past, or 1-year past vaccination), Risk factor of vaccination failure case, Antibody acqusition and retention rate after booster vaccination, Incidence of each vaccine corresponding infenction by non-viral strain.<br>Safety: Adverse events within 3 months ( vaccine corresponding infection onset, exacerbation of primary disease), Risk factor of AE and SAE.