Optimal Timing of Zoster Vaccine After Zoster Illness

October 12, 2017 updated by: Wan Beom Park, Seoul National University Hospital

Comparison of Immune Response Induced by Zoster Vaccine According to the Timing of Vaccination After Zoster Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6months to 2years after shingles
Patients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness.
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection.
Active Comparator: 2years to 5years after shingles
Patients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness.
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Varicella-zoster virus-specific interferon-gamma ELISPOT response
Time Frame: before Zostavax vaccination and at week 6 after vaccination
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.
before Zostavax vaccination and at week 6 after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody titer against glycoprotein of varicella-zoster virus
Time Frame: before Zostavax vaccination and at week 6 after vaccination
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.
before Zostavax vaccination and at week 6 after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Wan Beom Park, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1511046718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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