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Optimal Timing of Zoster Vaccine After Zoster Illness

Primary Purpose

Shingles

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zostavax
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shingles focused on measuring Herpes zoster vaccine, cell-mediated immunity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 50 years or older who have had shingles in 5 years
  • Adults who did not receive zoster vaccination yet
  • Adults who can understand and agreed with the informed consents.

Exclusion Criteria:

  • Adults who have conditions which is contraindication for zoster vaccine
  • Adults who had zoster vaccination already
  • Adults who take immunosuppressants
  • Human Immunodeficiency Virus (HIV) patients whose CD4 T cell counts below 500/mm3
  • Adults with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
  • Adults who had organ transplantation and receive immunosuppressants
  • Adults who are suspected to have active infectious disease
  • Adults who are not eligible for zoster vaccination by investigator's assessment

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

6months to 2years after shingles

2years to 5years after shingles

Arm Description

Patients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness.

Patients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness.

Outcomes

Primary Outcome Measures

Varicella-zoster virus-specific interferon-gamma ELISPOT response
Investigators measure the number of SFC (spot forming cells) using interferon-gamma ELISPOT (enzyme-linked immunospot) assay at both right before vaccination and week 6 after vaccination and see the change between two values.

Secondary Outcome Measures

Antibody titer against glycoprotein of varicella-zoster virus
Investigators measure the titer of VZV-specific glycoprotein-based enzyme-linked immunosorbent assay at both right before vaccination and week 6 after vaccination and see the fold change between two values.

Full Information

First Posted
March 1, 2016
Last Updated
October 12, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02704572
Brief Title
Optimal Timing of Zoster Vaccine After Zoster Illness
Official Title
Comparison of Immune Response Induced by Zoster Vaccine According to the Timing of Vaccination After Zoster Illness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 patients aged over 50 with history of zoster within 5 years.
Detailed Description
Zoster vaccination is recommended by FDA for adults aged 60 years or older, and is approved for people aged 50 through 59 years old. For patients who had shingles, there is no specific length of time they must wait before receiving shingles vaccine. It is generally recommended that patients should wait for 6 to 12 months after recovery. The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after zoster illness by comparing immune response between two groups (vaccination at 6 months to 2 years after shingles vs. 2 to 5 years after shingles). Primary outcome is ELISPOT response at week 6 after vaccination. Secondary outcome is gpELISA titer at week 6 after vaccination. All the patients will be asked if they have any contraindications 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles
Keywords
Herpes zoster vaccine, cell-mediated immunity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6months to 2years after shingles
Arm Type
Experimental
Arm Description
Patients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness.
Arm Title
2years to 5years after shingles
Arm Type
Active Comparator
Arm Description
Patients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness.
Intervention Type
Biological
Intervention Name(s)
Zostavax
Intervention Description
Zostavax will be administrated by subcutaneous injection.
Primary Outcome Measure Information:
Title
Varicella-zoster virus-specific interferon-gamma ELISPOT response
Description
Investigators measure the number of SFC (spot forming cells) using interferon-gamma ELISPOT (enzyme-linked immunospot) assay at both right before vaccination and week 6 after vaccination and see the change between two values.
Time Frame
before Zostavax vaccination and at week 6 after vaccination
Secondary Outcome Measure Information:
Title
Antibody titer against glycoprotein of varicella-zoster virus
Description
Investigators measure the titer of VZV-specific glycoprotein-based enzyme-linked immunosorbent assay at both right before vaccination and week 6 after vaccination and see the fold change between two values.
Time Frame
before Zostavax vaccination and at week 6 after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 50 years or older who have had shingles in 5 years Adults who did not receive zoster vaccination yet Adults who can understand and agreed with the informed consents. Exclusion Criteria: Adults who have conditions which is contraindication for zoster vaccine Adults who had zoster vaccination already Adults who take immunosuppressants Human Immunodeficiency Virus (HIV) patients whose CD4 T cell counts below 500/mm3 Adults with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine Adults who had organ transplantation and receive immunosuppressants Adults who are suspected to have active infectious disease Adults who are not eligible for zoster vaccination by investigator's assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Beom Park, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25985906
Citation
Gilbert PB, Gabriel EE, Hudgens MG, Miao X, Li X, Su SC, Parrino J, Chan IS. Reply to Dunning. J Infect Dis. 2015 Nov 1;212(9):1521-3. doi: 10.1093/infdis/jiv287. Epub 2015 May 17. No abstract available.
Results Reference
background
PubMed Identifier
18419349
Citation
Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.
Results Reference
background
PubMed Identifier
20416263
Citation
Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
Results Reference
background
PubMed Identifier
26546878
Citation
Kim JW, Min CK, Mun YC, Park Y, Kim BS, Nam SH, Koh Y, Kwon JH, Choe PG, Park WB, Kim I. Varicella-zoster virus-specific cell-mediated immunity and herpes zoster development in multiple myeloma patients receiving bortezomib- or thalidomide-based chemotherapy. J Clin Virol. 2015 Dec;73:64-69. doi: 10.1016/j.jcv.2015.10.018. Epub 2015 Oct 24.
Results Reference
background
PubMed Identifier
17950022
Citation
Kang CI, Choi CM, Park TS, Lee DJ, Oh MD, Choe KW. Incidence of herpes zoster and seroprevalence of varicella-zoster virus in young adults of South Korea. Int J Infect Dis. 2008 May;12(3):245-7. doi: 10.1016/j.ijid.2007.08.002. Epub 2007 Oct 18.
Results Reference
background
PubMed Identifier
30600654
Citation
Lee E, Chun JY, Song KH, Choe PG, Bang JH, Kim ES, Kim HB, Park SW, Kim NJ, Park WB, Oh MD. Optimal Timing of Zoster Vaccination After Shingles: A Prospective Study of the Immunogenicity and Safety of Live Zoster Vaccine. Infect Chemother. 2018 Dec;50(4):311-318. doi: 10.3947/ic.2018.50.4.311.
Results Reference
derived

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Optimal Timing of Zoster Vaccine After Zoster Illness

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