Unique ID issued by UMIN | UMIN000032992 |
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Receipt number | R000037618 |
Scientific Title | A clinical study to inspect whether live attenuated VZV vaccine inoculation induces antitumor immunity in patients with CML and patients with MDS |
Date of disclosure of the study information | 2018/06/14 |
Last modified on | 2022/06/30 14:51:38 |
A clinical study to inspect whether live attenuated varicella zoster virus (VZV) vaccine inoculation induces antitumor immunity in patients with chronic myelogenous leukemia (CML) and patients with myelodysplastic syndromes (MDS)
VCAM study
A clinical study to inspect whether live attenuated VZV vaccine inoculation induces antitumor immunity in patients with CML and patients with MDS
VCAM study
Japan |
Chronic myelogenous leukemia (CML) and myelodysplastic syndromes (MDS)
Hematology and clinical oncology |
Malignancy
NO
We inspect whether live attenuated VZV vaccine inoculation induces tumor specific cytotoxic T-lymphocyte (CTL) in patients with chronic myelogenous leukemia (CML) undergoing tyrosine kinase inhibitors (TKI) therapy and patients with myelodysplastic syndromes (MDS) undergoing Azacitidine (Aza), and also the safety of VZV vaccine inoculation.
Safety,Efficacy
Confirmatory
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
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Vaccine |
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 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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
25
1st name | Tatsuro |
Middle name | |
Last name | Jo |
Japanese Red Cross Society Nagasaki Genbaku Hospital
Hematology
852-8511
3-15 Mori-machi, Nagasaki City, Nagasaki
095-847-1511
tjmahamayurijnt@gmail.com
1st name | Tatsuro |
Middle name | |
Last name | Jo |
Japanese Red Cross Society Nagasaki Genbaku Hospital
Hematology
852-8511
3-15 Mori-machi, Nagasaki City, Nagasaki
095-847-1511
tjmahamayurijnt@gmail.com
Japanese Red Cross Society Nagasaki Genbaku Hospital
The Research Foundation for Microbial Diseases of Osaka University
Profit organization
Japan
The Research Foundation for Microbial Diseases of Osaka University
Shiga University of Medical Science Research Ethics Committee
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
077-548-3576
hqrec@belle.shiga-med.ac.jp
YES
jRCTs051180106
Japan Registry of Clinical Trials
日本赤十字社長崎原爆病院(長崎県)
Japanese Red Cross Society Nagasaki Genbaku Hospital (Nagasaki)
2018 | Year | 06 | Month | 14 | Day |
Unpublished
12
Completed
2018 | Year | 02 | Month | 26 | Day |
2018 | Year | 03 | Month | 08 | Day |
2018 | Year | 04 | Month | 25 | Day |
2021 | Year | 07 | Month | 31 | Day |
2022 | Year | 01 | Month | 30 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
Target sample size: 25 cases
Breakdown
CML: 10 cases, MDS RCMD:3-5 cases, MDS RAEB-1:3-5 cases, MDS RAEB-2:3-5 cases
Funding Source and Co-sponsor: The Research Foundation for Microbial Diseases of Osaka University (supported from Mar 27, 2018 to Dec 31, 2019)
2018 | Year | 06 | Month | 14 | Day |
2022 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037618
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