Immunological study of herpes zoster vaccine in diabetes and dialysis patients

JRCT ID: jRCTs031240031

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Herpes Zoster
• Date of first enrollment: 16/04/2024
• Target sample size: 198
• Study type: Interventional
• Intervention(s): Vaccination of dry recombinant Herpes Zoster vaccine (Shingrix)

Outcome(s)

Primary Outcome

Each Vaccine Response Rate (VRR)* at observation points 2 (2 months), 3 (3 months), 4 (8 months) and 5 (14 months)
*VRR: 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 Outcome

1. Summary statistics of anti-VZV gE antibody levels at each observation point.
2. Seroconversion rates at each observation point (percentage of cases with anti-VZV gE antibody levels of 97mIU/ml or higher).
3. Summary statistics of VZV-specific cellular and humoral immunity at each observation point (VZV-specific T cell and B cell profiles measured by flow cytometry)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Subjects who meet all of the following criteria are included in this study:
1. Male and female aged between 50 years and 80 years at giving their consent
2. 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
3. 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)".

Exclude criteria

Subjects who fall into any of the following criteria are excluded from participating in the study
<Exclusion criteria at the provisional registration>
1. Subjects with a history of herpes zoster within two years before giving their consent
2. Subjects with a history of vaccination with the herpes zoster vaccine
3. Subjects with a history of any vaccination within one month before giving their consent
4. Subjects who have a plan to receive other vaccinations within one month after the first and second vaccination of RZV in this study
5. Subjects with hematological coagulation disorder at giving their consent
6. 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
7. Subjects who Patients who received a hematopoietic stem cell transplant or any kind of organ donation in the past
8. Subjects who are clearly suffering from a serious acute illness at giving their consent
9. Subjects who have clearly experienced anaphylaxis due to any of the ingredients of this agent
10. Pregnant woman, or premenopausal women who do not agree to contraception
11. Subjects who are participating in other interventional trials
12. Subjects who need legal representative for giving consent
13. Subjects who are considered to be unsuitable for participating in this study by investigators

<Exclusion criteria at the registration>
14. Subjects with anti-HIV antibody positive at giving their consent or the screening tests*
15. 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*
16. 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*
17. Subjects with HbA1c of 6.5% or higher in the Group A (Control group) at giving their consent or the screening tests*
18. 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 *
19. Subjects who have developed herpes zoster between the time of provisional registration and the time of registration
20. Subjects who received herpes zoster vaccine between the time of provisional registration and the time of registration
21. Subjects who received any vaccine between the time of provisional registration and the time of registration
22. Subjects who had any hematological coagulation disorder between the time of provisional registration and the time of registration
23. 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
24. 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
25. 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
26. Subjects who have participated in other intervention studies between the time of provisional registration and the time of registration
27. 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.

Related Information

• Primary Sponsor: Yoshifuji Ayumi
• Source(s) of Monetary Support: GlaxoSmithKline K.K.