A clinical trial to inspect whether varicella zoster virus vaccine inoculation induces antitumor immunity in patients with adult T-cell leukemia/lymphoma

Not Applicable

• Conditions: Adult T-cell leukemia/lymphoma

• Registration Number: JPRN-jRCTs051180107
• Lead Sponsor: Jo Tatsuro

Brief Summary

ive attenuated VZV vaccination to ATLL patients led to moderate increase of HTLV-1 Tax-specific CTL in 1 of 3 indolent-type patients, while HTLV-1 Tax-specific CTLs were increased by VZV vaccination in all three aggressive-type patients treated with mogamulizumab plus chemotherapy. 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: 2020-04-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Patients who meet all of the following criteria are eligible as subjects of this study.
1) HTLV-1 antibody is positive. The diagnosis is made as a peripheral lymphoid tumor cytologically or histopathologically
2) CCR4 antigen of the tumor is positive in flow cytometric analysis or immunohistochemical analysis
3) An anti-VZV antibody [IAHA or EIA(IgG)] is positive (more than 4 times) before VZV vaccine inoculation
4) It is confirmed csllular immunocompetence of patients is enough (with positive results of lymphocyte stimulation test for PHA and Con-A)
5) The patients have HLA type A*02:01 or A*24:02
6) To enroll the patients that Moga alone or Moga+ chemotherapy has been already started is permitted
7) The patients 20 years or older can be enrolled
8) 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) In the case that the patient has another active primary cancer
3) In the case that HBs antigen is positive
4) In the case that HIV antibody is positive
5) Women during pregnancy or lactating
6) In case of the patient is complicated with psychosis or psychiatric symptoms, and it is judged that the enrollment of the study is difficult
7) In the case that the patient has a disease, which is not ATLL, with the immunodeficiency or the immunosuppression. In the case that the patient receives an immunosuppressive therapy
8) 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 anti-HTLV-1 specific CTL or not.

Secondary Outcome Measures

Name	Time	Method
The safety assessment of adverse events induced by VZV vaccination