Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

Seoul National University

Status: Completed

Conditions: Herpes Zoster

Treatments: Biological: Zostavax

Study type: Interventional

Funder types: Other

Identifiers

NCT03192319

H1705030852

Details and patient eligibility

About

The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).

Full description

Due to lack of data on safety of live vaccine in the recipient of hematopoietic stem cell transplantation, CIBMTR(Center for International Blood and Marrow Transplant Research) guidelines recommend varicella vaccination only in patients who is at least two years after transplantation and without graft versus host disease and no immunosuppressive drug.

However, recent studies have demonstrated the safety and efficacy of shingles vaccination in patients receiving hematopoietic stem cell transplantation.

But, there is no basis for timing of live vaccine administration after HSCT.

The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after HSCT by comparing immune response between two groups(vaccination at 2 to 5years after HSCT vs. 5 to 10years after HSCT). Primary outcome is interferon gamma releasing ELISPOT response at week 6 after vaccination. Secondary outcome is ELISA titer for zoster-specific IgG at week 6 after vaccination.

All the patients will be asked if they have any contraindication for zoster vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 6 weeks(visiting the hospital).

In order to confirm the efficacy of the experiment, 30 healthy controls and 30 patients who were treated with chemotherapy alone for leukemia were selected. The control group will also apply the same protocol as above.

Enrollment: 86 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 50 years or older who is at least 2 years after hematopoietic stem cell transplantation (Experimental group)
• Adults aged 50 years or older who is at least 6 months after being cured by chemotherapy for leukemia (Control group)
• Healthy Adults aged 50 years or older who do not meet exclusion criteria (Control group)
• Adults who can understand and agreed with the informed consents

Exclusion criteria

• Adults who have conditions which is contraindication for zoster vaccine
• Adults who take immunosuppressant
• Adults with graft versus host disease(GVHD)
• Adults who take antivirals agent
• Adults who experienced VZV infection after hematopoietic stem cell transplantation
• Adults who received VZV vaccination already after hematopoietic stem cell transplantation
• Adults who are not eligible for zoster vaccination by investigator's assessment

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 4 patient groups

2years to 5years after HCT

Experimental group

Description:

Patients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation

Treatment:

Biological: Zostavax

5years to 10years after HCT

Active Comparator group

Description:

Patients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation

Treatment:

Biological: Zostavax

6 month after chemotherapy for leukemia

Active Comparator group

Description:

Patients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy

Treatment:

Biological: Zostavax

healthy people

Active Comparator group

Description:

Healthy adults over 50 years old will be vaccinated with Zostavax

Treatment:

Biological: Zostavax