A clinical study to inspect whether live attenuated VZV vaccine inoculation induces antitumor immunity in patients with CML and patients with MDS

Not Applicable

• Conditions: Chronic myelogenous leukemia (CML) , Myelodysplastic syndromes (MDS)

• Registration Number: JPRN-jRCTs051180106
• Lead Sponsor: Jo Tatsuro

Brief Summary

ive attenuated VZV vaccination to chronic CML patients on TKI therapy led to increase of tumor-specific CTL in 3 of 10 patients, while tumor-specific CTLs were increased by VZV vaccination in 1 of 2 MDS patients on Aza therapy. In the present study, live attenuated VZV vaccination could be safely administered to ATLL patients under some conditions, such as with the positivity of anti-VZV antibodies and proof of sufficient cellular immunity in under control tumor.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Study Completion: 2021-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

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

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) In the case that the patient is judged to be unsuitable for a trial entry by the medical attendant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether VZV vaccination can induce tumor specific CTL or not.

Secondary Outcome Measures

Name	Time	Method
1) Up-regulation of VZV specific cell mediated immunity by VZV vaccination<br>2) The safety assessment of adverse events induced by VZV vaccination