Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-03-31
2017-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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6months to 2years after shingles
Patients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness.
Zostavax
Zostavax will be administrated by subcutaneous injection.
2years to 5years after shingles
Patients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness.
Zostavax
Zostavax will be administrated by subcutaneous injection.
Interventions
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Zostavax
Zostavax will be administrated by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* Adults who did not receive zoster vaccination yet
* Adults who can understand and agreed with the informed consents.
Exclusion Criteria
* 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
50 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Wan Beom Park
Associate Professor
Principal Investigators
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Wan Beom Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Gilbert PB, Gabriel EE, Hudgens MG, Miao X, Li X, Su SC, Parrino J, Chan IS. Reply to Dunning. J Infect Dis. 2015 Nov 1;212(9):1521-3. doi: 10.1093/infdis/jiv287. Epub 2015 May 17. No abstract available.
Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.
Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
Kim JW, Min CK, Mun YC, Park Y, Kim BS, Nam SH, Koh Y, Kwon JH, Choe PG, Park WB, Kim I. Varicella-zoster virus-specific cell-mediated immunity and herpes zoster development in multiple myeloma patients receiving bortezomib- or thalidomide-based chemotherapy. J Clin Virol. 2015 Dec;73:64-69. doi: 10.1016/j.jcv.2015.10.018. Epub 2015 Oct 24.
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.
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.
Other Identifiers
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H1511046718
Identifier Type: -
Identifier Source: org_study_id