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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 13, 2017
October 1, 2017
1.4 years
March 1, 2016
October 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Varicella-zoster virus-specific interferon-gamma ELISPOT response
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.
before Zostavax vaccination and at week 6 after vaccination
Secondary Outcomes (1)
Antibody titer against glycoprotein of varicella-zoster virus
before Zostavax vaccination and at week 6 after vaccination
Study Arms (2)
6months to 2years after shingles
EXPERIMENTALPatients will be vaccinated with Zostavax from 6 months to 2 years after zoster illness.
2years to 5years after shingles
ACTIVE COMPARATORPatients will be vaccinated with Zostavax from 2 years to 5 years after zoster illness.
Interventions
Zostavax will be administrated by subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (6)
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.
PMID: 25985906BACKGROUNDLevin 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.
PMID: 18419349BACKGROUNDMills 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.
PMID: 20416263BACKGROUNDKim 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.
PMID: 26546878BACKGROUNDKang 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.
PMID: 17950022BACKGROUNDLee 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.
PMID: 30600654DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan Beom Park, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 10, 2016
Study Start
March 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
October 13, 2017
Record last verified: 2017-10