diabetes mellitus
Conditions
Interventions
A: saline+saline
B: varicella vaccine+saline
C: varicella vaccine+varicella vaccine
Sponsors
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diabetic patients with HbA1c(JDS) 6-9.5% Diabetic patients diagnosed by a physician based on the Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus(J Diabetes Investig.1:212-28. 2010).
Exclusion criteria
Exclusion criteria: Excluded were users of steroids or other immunosuppressive drugs, those with heart disease treated by antiplatelet drugs, immunocompromised patients with any potential malignant disease, autoimmune disease, renal failure, patients with immunization of varicella vaccine within 5 years, HZ patients, andsmokers,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| varicella zoster virus-specific cell-mediated immunity by using an interferon-g enzyme-linked immunosorbent assay at 3, 6 and 12 months after primary administration of vaccine or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| immunogenicity of varicella vaccine at 3, 6 and 12 months after primary administration of vaccine or placebo. safety of varicella vaccine for 12 months after after primary administration of vaccine or placebo. | — |
Countries
Japan
Contacts
Public ContactAtsuko Hata
The Tazuke Kofukai Medical Research Institute department of infectious diseases
Outcome results
None listed