Optimal Timing of Zoster Vaccine After Zoster Illness

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02704572

Enrollment

Registered

2016-03-10

Start date

2016-03-31

Completion date

2017-08-31

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shingles

Keywords

Herpes zoster vaccine, cell-mediated immunity

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).

Interventions

BIOLOGICALZostavax

Zostavax will be administrated by subcutaneous injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Varicella-zoster virus-specific interferon-gamma ELISPOT response	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

Measure	Time frame	Description
Antibody titer against glycoprotein of varicella-zoster virus	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026