Skip to main content
OpenTrials
Completed

NCT Number: NCT02704572

Optimal Timing of Zoster Vaccine 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zostavax

Biological

Zostavax will be administrated by subcutaneous injection.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.