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

JRCT ID: jRCTs051180106

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic myelogenous leukemia (CML) , Myelodysplastic syndromes (MDS)
• Date of first enrollment: 30/05/2018
• Target sample size: 25
• Study type: Interventional
• Intervention(s): VZV immunization was conducted twice with at least 12 weeks interval between 2 courses using the live attenuated varicella virus (Oka /BIKEN) vaccine. Each course included up to 5 doses of vaccine with 1 to 4 weeks intervals.

Outcome(s)

• Primary Outcome: Whether VZV vaccination can induce tumor specific CTL or not.

Secondary Outcome

1) Up-regulation of VZV specific cell mediated immunity by VZV vaccination
2) The safety assessment of adverse events induced by VZV vaccination

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Jo Tatsuro

Source(s) of Monetary Support

The Research Foundation for Microbial Diseases of Osaka University
(supported from Mar 27, 2018 to Dec 31, 2019)

• Secondary ID(s): UMIN000032992