Study of Live Attenuated Vaccine in Immunosuppressed Patients

JRCT ID: jRCTs031190140

Registered date:25/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Immunosuppressed patients
• Date of first enrollment: 08/06/2016
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Administer subcutaneously freeze-dried live attenuated measles and rubella combined vaccine, freeze-dried live attenuated measles vaccine, freeze-dried live attenuated rubella vaccine, freeze-dried live attenuated varicella vaccine, freeze-dried live attenuated measles vaccine, freeze-dried live attenuated mumps vaccine

Outcome(s)

Primary Outcome

Efficacy: Positive rate of each viral IgG 2-6 months after vaccination
Safety: Content and frequency of severe adverse events

Secondary Outcome

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.
Safety: Adverse events within 3 months ( vaccine corresponding infection onset, exacerbation of primary disease), Risk factor of AE and SAE.

Key inclusion & exclusion criteria

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

Include criteria

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/dL

Exclude criteria

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

Related Information

• Primary Sponsor: Nishimura Kenichi
• Secondary Sponsor: Ito Shuichi
• Secondary ID(s): UMIN000018627