Immunological study of herpes zoster vaccine in diabetes and dialysis patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 198
- Primary Endpoint
- Vaccine Response Rate (VRR) at 2 months
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 50age old over to 80age old under (—)
- Sex
- All
Inclusion Criteria
- •Subjects who meet all of the following criteria are included in this study:
- •Male and female aged between 50 years and 80 years at giving their consent
- •Subjects who meet one of the following criteria
- •i) Group A: Control group
- •Subjects who have not been diagnosed* with diabetes mellitus or chronic kidney disease (Stage G3b or higher) at the time of consent, nor had they been diagnosed in the past
- •ii) Group B: Diabetes mellitus group
- •Patients who are diagnosed with type 2 diabetes mellitus
- •Patients treated with any therapeutic agents for diabetes mellitus
- •Patients who have not been diagnosed* with chronic kidney disease (Stage G3b or higher) at the time of consent, nor had they been diagnosed in the past
- •iii) Group C: Hemodialysis group
- •Patients with hemodialysis
- •Subjects who give their consent in a written form
- •The diagnostic criteria for diabetes mellitus are based on the "Diabetes Treatment Guide 2022-2023" and the diagnosis of chronic kidney disease is based on the "CKD Severity Classification (CKD Practice Guide 2012)".
Exclusion Criteria
- •Subjects who fall into any of the following criteria are excluded from participating in the study
- •<Exclusion criteria at the provisional registration>
- •Subjects with a history of herpes zoster within five years before giving their consent
- •Subjects with a history of vaccination with the herpes zoster vaccine
- •Subjects with a history of any vaccination within one month before giving their consent
- •Subjects who have a plan to receive other vaccinations within one month after the first and second vaccination of RZV in this study
- •Subjects with hematological coagulation disorder at giving their consent
- •Subjects with malignancy and those who received treatments with systemic steroids, or systemic administration of immunosuppressive agents or immunomodulatory agents within two years before giving their consent
- •Subjects who Patients who received a hematopoietic stem cell transplant or any kind of organ donation in the past
- •Subjects who are clearly suffering from a serious acute illness at giving their consent
- •Subjects who have clearly experienced anaphylaxis due to any of the ingredients of this agent
- •Pregnant woman, or premenopausal women who do not agree to contraception
- •Subjects who are participating in other interventional trials
- •Subjects who need legal representative for giving consent
- •Subjects who are considered to be unsuitable for participating in this study by investigators
- •<Exclusion criteria at the registration>
- •Subjects with anti-HIV antibody positive at giving their consent or the screening tests*
- •Subjects with thrombocytopenia (Plt < 50,000/microL) or hepatic disorder (ALT or AST is 3 times or more higher than the upper limit of the standard value in each research institution) at giving their consent or the screening tests*
- •Subjects with urine protein creatinine ratio of 0.5 g/g Cre in the Group A (Control group) and the B (Diabetes mellitus group) at giving their consent or the screening tests*
- •Subjects with HbA1c of 6.5% or higher in the Group A (Control group) at giving their consent or the screening tests*
- •Subjects with eGFR of less than 45 mL/min/1.73m2 in the Group A (Control group) and the B (Diabetes mellitus group) at giving their consent or the screening tests *
- •Subjects who have developed herpes zoster between the time of provisional registration and the time of registration
- •Subjects who received herpes zoster vaccine between the time of provisional registration and the time of registration
- •Subjects who received any vaccine between the time of provisional registration and the time of registration
- •Subjects who had any hematological coagulation disorder between the time of provisional registration and the time of registration
- •Subjects who have been diagnosed with malignant tumor or treated with systemic steroids, immunosuppressive drugs or immunomodulators from the time of provisional registration and the time of registration
- •Subjects who received a hematopoietic stem cell transplant or any kind of organ donation between the time of provisional registration and the time of registration
- •Subjects who are found to be pregnant or premenopausal women who refused to consent to contraception between the time of provisional registration and the time of registration
- •Subjects who have participated in other intervention studies between the time of provisional registration and the time of registration
- •Other, subjects whose attending physician determines that they are not eligible to participate in this study
- •If the measurement was performed under regular medical care within one month prior to the time of consent, the most recent test result at the time of consent is used to determine the eligibility criteria. If the measurement has not been performed under regular medical care within one month prior to obtaining consent, a screening test will be performed after provisional enrollment, and the results of that screening test will be used to determine eligibility criteria. If data are available for both tests, the subject will be excluded if any of the exclusion criteria are met by either test.
Outcomes
Primary Outcomes
Vaccine Response Rate (VRR) at 2 months
Time Frame: 2 months
Proportion of cases meeting the following criteria: - Serum anti-varicella-zoster virus (VZV) glycoprotein E (gE) antibody level (anti-VZV gE antibody level) at Observation Point 1 (baseline) less than 97 milli-International Units (mIU)/ml: Anti-VZV gE antibody level at this Observation Point was 388mIU/ml or higher - Anti-VZV gE antibody level at Observation Point 1 (baseline) is greater than or equal to 97mIU/ml: Anti-VZV gE antibody level at this Observation Point is greater than or equal to 4 times the level at Observation Point 1 (baseline)
Vaccine Response Rate (VRR) at 3 months
Time Frame: 3 months
Proportion of cases meeting the following criteria: - Serum anti-varicella-zoster virus (VZV) glycoprotein E (gE) antibody level (anti-VZV gE antibody level) at Observation Point 1 (baseline) less than 97 milli-International Units (mIU)/ml: Anti-VZV gE antibody level at this Observation Point was 388mIU/ml or higher - Anti-VZV gE antibody level at Observation Point 1 (baseline) is greater than or equal to 97mIU/ml: Anti-VZV gE antibody level at this Observation Point is greater than or equal to 4 times the level at Observation Point 1 (baseline)
Vaccine Response Rate (VRR) at 8 months
Time Frame: 8 months
Proportion of cases meeting the following criteria: - Serum anti-varicella-zoster virus (VZV) glycoprotein E (gE) antibody level (anti-VZV gE antibody level) at Observation Point 1 (baseline) less than 97 milli-International Units (mIU)/ml: Anti-VZV gE antibody level at this Observation Point was 388mIU/ml or higher - Anti-VZV gE antibody level at Observation Point 1 (baseline) is greater than or equal to 97mIU/ml: Anti-VZV gE antibody level at this Observation Point is greater than or equal to 4 times the level at Observation Point 1 (baseline)
Vaccine Response Rate (VRR) at 14 months
Time Frame: 14 months
Proportion of cases meeting the following criteria: - Serum anti-varicella-zoster virus (VZV) glycoprotein E (gE) antibody level (anti-VZV gE antibody level) at Observation Point 1 (baseline) less than 97 milli-International Units (mIU)/ml: Anti-VZV gE antibody level at this Observation Point was 388mIU/ml or higher - Anti-VZV gE antibody level at Observation Point 1 (baseline) is greater than or equal to 97mIU/ml: Anti-VZV gE antibody level at this Observation Point is greater than or equal to 4 times the level at Observation Point 1 (baseline)
Secondary Outcomes
- Summary statistics of anti-VZV gE antibody levels(each observation point)
- Seroconversion rates(each observation point)
- Summary statistics of VZV-specific cellular and humoral immunity(each observation point)