Clinical trial NCT02704572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shingles
Keywords: Herpes zoster vaccine
cell-mediated immunity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Varicella-zoster virus-specific interferon-gamma ELISPOT response
timeFrame: before Zostavax vaccination and at week 6 after vaccination
Secondary outcomes:
measure: Antibody titer against glycoprotein of varicella-zoster virus
timeFrame: before Zostavax vaccination and at week 6 after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Wan Beom Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.