Optimal Timing of Zoster Vaccine After Zoster Illness

Seoul National University

Status: Completed

Conditions: Shingles

Treatments: Biological: Zostavax

Study type: Interventional

Funder types: Other

Identifiers

NCT02704572

H1511046718

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

6months to 2years after shingles

Experimental group

Description:

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

Treatment:

Biological: Zostavax

2years to 5years after shingles

Active Comparator group

Description:

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

Treatment:

Biological: Zostavax