Chronic myelogenous leukemia (CML) and myelodysplastic syndromes (MDS)
Conditions
Interventions
VZV vaccine Dissolve this product in 0.7 mL of the attached solvent (Japanese Pharmacopoeia for Injection Water), and inject 0.5 mL of this solution subcutaneously. VZV immunization was conducted
Sponsors
Japanese Red Cross Society Nagasaki Genbaku Hospital
The Research Foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible as subjects of this study. 1) Chronic phase CML patients undergoing TKI therapy and MDS patients undergoing Aza therapy. 2) An anti-VZV antibody is positive [IAHA or EIA (IgG) is more than 4 times]. 3) It is confirmed before VZV vaccine inoculation that cellar immunocompetence of patients is enough (with positive reactions of lymphocyte stimulation test for PHA and Con-A). 4) The patients have HLA type A*02:01(02:06) or A*24:02. 5) In the case that the patient is healing from cancer, which is not CML or MDS, developed more than 5 years ago. In the case that the patient has inactive cancer, which is not CML or MDS, developed in 5 years. 6) Women agree with contraception 1 month before and 2 months after VZV vaccination. 7) 20 years old or more and less than 80 years old. 8) In case of MDS, ineligible for hematopoietic stem cell transplantation, or the patient does not wish to receive it.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study. 1) In the case of an infectious disease due to a virus belonging to Herpesviridae or a VZV vaccination other than the study vaccine in a year before inoculation of VZV vaccine. 2) Patients who have risk of allergy due to an ingredient of the product (Erythromycin lactobionate, Kanamycin sulfate). 3) HIV antibody is positive. 4) Women during pregnancy or lactating. 5) In case of the patient is complicated with psychosis or psychiatric symptoms, and it is judged that the enrollment of the study is difficult. 6) In the case that the patient has a disease, which is not CML or MDS, with the immunodeficiency or the immunosuppression. In the case that the patient receives an immunosuppressive therapy. 7) Any other reason that disqualifies the patients from participating in this study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether VZV vaccination can induce tumor specific CTL or not: Evaluation of tumor specific CTLs before VZV vaccination and every 2 or 3 months for 12 months after the final inoculation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Enhancement of VZV specific cell mediated immunity (CMI) by VZV vaccination: Evaluation of VZV specific CD4 and CD8 T-cells before VZV vaccination and every 2 or 3 months for 12 months after the final inoculation 2) The safety assessment of adverse events induced by VZV vaccination | — |
Countries
Japan
Contacts
Public ContactTatsuro Jo
Japanese Red Cross Society Nagasaki Genbaku Hospital Hematology
Outcome results
None listed