Optimal Timing of Zoster Vaccine After Zoster Illness

Shingles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704572
• Other study ID #: H1511046718
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: October 12, 2017
• Start date: March 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Biological:
• Zostavax
Zostavax will be administrated by subcutaneous injection.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. Epub 2007 Oct 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibody titer against glycoprotein of varicella-zoster virus	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.	before Zostavax vaccination and at week 6 after vaccination