NCT03192319

Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Zostavax	Zostavax will be administrated by subcutaneous injection

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-08-23
• Completion: 2018-08-23
• First posted: 2017-06-20
• Last updated: 2019-04-04

Locations

1 site across 1 country: South Korea